COVID-19 TESTING AND TRACING: LESSONS LEARNED AND A LOOK AHEAD

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Ramana N.V. Gandham Ronald Mutasa Suresh Kunhi Mohammed Guru Rajesh Jammy Aarushi Bhatnagar

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COVID-19 TESTING AND TRACING:

LESSONS LEARNED AND A LOOK AHEAD

Ramana N.V. Gandham Ronald Mutasa, Suresh Kunhi Mohammed,

Guru Rajesh Jammy, and Aarushi Bhatnagar

August 30, 2020

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Health, Nutrition, and Population Discussion Paper This series is produced by the Health, Nutrition and Population (HNP) Global Practice of the World Bank. The papers in this series aim to provide a vehicle for publishing preliminary results on HNP topics to encourage discussion and debate. The findings, interpretations, and conclusions expressed in this paper are entirely those of the author(s) and should not be attributed in any manner to the World Bank, to its affiliated organizations, or to members of its Board of Executive Directors or the countries they represent. Citation and the use of material presented in this series should take into account this provisional character. The World Bank does not guarantee the accuracy of the data included in this work. The boundaries, colors, denominations, and other information shown on any map in this work do not imply any judgment on the part of the World Bank concerning the legal status of any territory or the endorsement or acceptance of such boundaries. For information regarding the HNP Discussion Paper Series, please contact the Editor, Jo Hindriks, at jhindriks@worldbank.org, or Erika Yanick at eyanick@worldbank.org.

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Health, Nutrition, and Population (HNP) Discussion Paper

COVID-19 TESTING AND TRACING: Lessons Learned and a Look Ahead

Ramana N.V. Gandham,a Ronald Mutasa,b Suresh Kunhi Mohammed,c Guru Rajesh Jammy,d and Aarushi Bhatnagare a Technical Advisor/Consultant (Health, Nutrition, and Population, South Asia Region) b Senior Health Specialist, Task Team Leader (Health, Nutrition, and Population, South Asia Region) c Senior Health Specialist, Co-Task Team Leader (Health, Nutrition, and Population, South Asia Region) d Epidemiologist/Consultant (Health, Nutrition, and Population, South Asia Region)

e Health Economist (Health, Nutrition, and Population, South Asia Region)

Funding from the Gates Foundation for the COVID-19 Technical Assistance is gratefully acknowledged. Abstract: The COVID-19 pandemic has ravaged the global economy, either reversing or slowing ongoing efforts to eliminate extreme poverty in many countries. Despite recent progress, including increased recoveries and lower death rates, India is ranked third globally in absolute numbers of COVID-19 reported cases. India’s chronic underinvestment in health, coupled with a hard-hit economic sector, has further entrenched segments of India’s population in vulnerability and poverty. The exodus of millions of migrants from the cities has contributed to the spread of infection from urban to rural areas, where health systems are weaker. As economic activities are revived following a period of lockdowns, policy makers must make smart choices that prevent and rein in the spread of COVID-19. In the absence of effective treatment and a vaccine, preventive measures combined with testing and tracing—followed by quarantine/isolation and supportive treatment—are critical to minimize the spread of COVID-19 and rejuvenate livelihoods to restore India’s economy. In this paper, we bring together promising testing and tracing lessons and approaches from India and globally, based on a desk review of various initiatives and analyses of secondary data. Key lessons and findings are that (i) testing and tracing is central to an effective COVID-19 response; (ii) a robust response to an unprecedented pandemic requires creative approaches, such as active case finding, pooled testing, testing environmental samples, triangulation of microdata, effective contact tracing, and partnering with the private sector; (iii) optimizing COVID-19 testing capacity should not negatively impact ongoing disease control programs; (iv) containment of COVID-19 should go hand-in-hand with preparation for future pandemics. We also summarize innovations and bottlenecks to rapidly scale up testing capacities at the state level, including strategies for optimizing the role of the private sector and introducing new technologies to enhance access to testing in rural populations. This paper offers options especially relevant to Indian policy makers, with a focus on sustained health systems strengthening.

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Keywords: COVID-19, testing, contact tracing, India Disclaimer: The findings, interpretations, and conclusions expressed in the paper are entirely those of the authors, and do not represent the views of the World Bank, its Executive Directors, or the countries they represent. Correspondence Details: Dr. Ronald Mutasa, The World Bank, 1818 H Street, NW, Washington DC, USA. www.worldbank.org.

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Table of Contents ACKNOWLEDGMENTS ................................................................................... VIII

PART I – KEY MESSAGES ............................................................................. - 1 -

PART II – INTRODUCTION ............................................................................. - 2 -

PART III – LIMITATIONS ................................................................................. - 3 -

PART IV – EPIDEMIOLOGY ........................................................................... - 4 -

PART V – TESTING ........................................................................................ - 5 - WHY IS TESTING SO CRITICAL? ........................................................................... - 5 - WHO SHOULD BE TESTED? ................................................................................ - 6 - STRONG PROGRESS, YET MORE TO DO ............................................................... - 7 - IS INDIA TESTING ENOUGH? ............................................................................... - 9 - HOW TO OPTIMIZE TESTING? ............................................................................ - 11 - HOW TO CREATE DEMAND FOR TESTING? .......................................................... - 15 - HOW TO ENSURE TEST QUALITY? ..................................................................... - 15 -

PART VI – TRACING ..................................................................................... - 16 - WHY CONTACT TRACING IS CRITICAL? ............................................................... - 16 - WHAT INNOVATIONS CAN IMPROVE TRACING? .................................................... - 17 - TRADITIONAL METHODS OF CONTACT TRACING .................................................. - 17 - DIGITAL CONTACT TRACING ............................................................................. - 19 -

PART VII – TESTING AND TRACING FOR VULNERABLE GROUPS ......... - 23 - MIGRANT LABOR AND FOREIGN RETURNEES ...................................................... - 23 - URBAN RESIDENTS .......................................................................................... - 25 - FRONTLINE WORKERS ..................................................................................... - 27 -

PART VIII – WAY FORWARD ....................................................................... - 29 - IMMEDIATE MEASURES .................................................................................... - 29 - MEDIUM-TERM MEASURES .............................................................................. - 30 -

ANNEX I: COMPARISON OF DIFFERENT TESTING METHODS FOR SARS-COV-2 ............................................................................................................ - 31 -

ANNEX II: PRELIMINARY UNIT COST ESTIMATES OF ICMR-APPROVED COVID-19 DIAGNOSTIC TESTS ................................................................... - 31 -

ANNEX III: UNIVERSAL SCREENING AND TARGETED TESTING — COSTS AND EFFICIENCY .............................................................................................. 36

ANNEX IV: TESTING AND TRACING – ROLES AND RESPONSIBILITIES AT DIFFERENT LEVELS OF SERVICE DELIVERY ................................................ 37

REFERENCES ................................................................................................... 39

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List of Figures:

FIGURE 1: DISTRIBUTION OF STATES BY POSITIVE TESTS (PERCENT) - 4 -

FIGURE 2: DAILY NEW COVID-19 TESTS ..................................................... - 9 -

FIGURE 3: STATES PERFORMING MORE THAN 140 TESTS PER DAY (PER MILLION POPULATION) ................................................................................. - 9 -

FIGURE 4: COMPARISON OF DAILY AND CUMULATIVE TEST POSITIVITY IN SELECTED COUNTRIES ................................................................................ - 9 -

FIGURE 5: COMPARISON OF DAILY AND CUMULATIVE TEST POSITIVITY IN SELECTED INDIAN STATES ........................................................................ - 10 -

FIGURE 6: STATES OPTIMIZING TESTING CAPACITY ............................. - 11 -

FIGURE 7: STATES UNDERUTILIZING TESTING CAPACITY .................... - 11 -

FIGURE 8: MARKET FORCES AFFECTING PRIVATE SECTOR PRODUCTION ....................................................................................................................... - 13 -

FIGURE 9: CONTACT TRACING AND TEST POSITIVITY IN SELECTED INDIAN STATES AND DELHI(PERCENT) .................................................... - 16 -

FIGURE 10: EARLY INTRODUCTION OF EFFECTIVE CONTACT TRACING, TESTING, AND ISOLATION ARE AN IMPORTANT PART OF KERALA’S RESPONSE TO COVID-19 PANDEMIC ........................................................ - 19 -

FIGURE 11: REGIONAL DISTRIBUTION AND EPIDEMIOLOGICAL LINKS OF COVID-19 CASE CLUSTERS IN SELECTED REGIONS OF SOUTH KOREA - 20 -

FIGURE 12: CONTRIBUTION OF INTERSTATE MIGRATION TO COVID-19 IN MAHARASHTRA ........................................................................................... - 24 -

FIGURE 13: DISTRIBUTION OF STATES BY EXISTING TESTING CAPACITY (PER MILLION, JULY 15, 2020) .................................................................... - 25 -

FIGURE14: FRAMEWORK FOR EFFICIENT DIGITAL CONTACT TRACING - 30 -

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List of Tables:

TABLE 1: COMPARISON OF TWO TESTING APPROACHES....................... - 5 -

TABLE 2: ICMR STRATEGY TO RAPIDLY EXPAND LABORATORY NETWORK FOR COVID-19 TESTING ............................................................................... - 8 -

TABLE 3: COVID-19 TESTS APPROVED IN INDIA ........................................ - 8 -

TABLE 4: CASE COUNT—THE CHANGING PICTURE ............................... - 23 -

TABLE 5: DISTRIBUTION OF COVID-19 CONFIRMED CASES, DEATHS AND RECOVERIES IN SEVEN INDIAN CITIES (AS OF JUNE 23, 2020) ............. - 25 -

List of Boxes:

BOX 1: PRIORITIES FOR COVID-19 TESTING (NUCLEIC ACID OR ANTIGEN) ......................................................................................................................... - 6 -

BOX 2: ICMR TESTING STRATEGY .............................................................. - 6 -

BOX 3: UNIT COST FOR RT-PCR TESTS ................................................... - 12 -

BOX 4: BHILWARA MODEL .......................................................................... - 18 -

BOX 5: AAROGYA SETU .............................................................................. - 20 -

BOX 6: KARNATAKA, “THE CORE OF COVID-19 CONTAINMENT IS CONTACT TRACING” ................................................................................... - 21 -

BOX 7: UNIVERSAL SCREENING AND TARGETED TESTING IN CONTAINMENT ZONES ............................................................................... - 26 -

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ACKNOWLEDGMENTS

This discussion paper was peer reviewed by Abdo Yazbeck, Former Lead Economist/World Bank; Miriam Schneidman, Lead Health Specialist; Owen Smith, Senior Health Economist; Mickey Chopra, Global Solutions Lead for Service Delivery; David Wilson, Global AIDS Program Director; and Sara Hersey, Senior Health Specialist.

The authors gratefully acknowledge the guidance and input of Trina Haque, Practice Manager for South Asia/World Bank and Junaid Ahmad, Country Director for India/World Bank.

The authors acknowledge Leah Jones, Knowledge Management Consultant for reviewing and editing the manuscript.

The authors thank the World Bank for publishing this report as an HNP Discussion Paper.

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PART I – KEY MESSAGES

1. Testing and tracing is key to an effective COVID-19 response. The carnage of COVID-19 in terms of loss of life and increased poverty is already an historic global tragedy, with South Asia emerging as one of the pandemic’s epicenters. The novelty of the virus means that the public health sector has limited tools to fight it. In the absence of an effective vaccine or treatment, individual preventive measures coupled with testing and tracing—followed by quarantine/isolation and supportive treatment—are critical to limiting new infections and future deaths, while allowing a relatively safe pathway to opening up the economy to fight deeper levels of poverty.

2. Mounting a robust response to an unprecedented pandemic. In India, early lockdowns gave the government room to assemble a robust response to the pandemic. India’s pandemic response included surging public health systems capacity and partnering with the private sector to ramp up laboratory capacity to increase and sustain testing. Still, more intensive and strategic actions are needed, with lessons to apply from within India and globally. These strategic actions include the following:

• Creative approaches to protect most vulnerable groups, including urban slum residents, migrants, and frontline workers. Such approaches include (i) active case finding in densely populated containment zones, (ii) pooled testing and periodic serological surveys covering high-risk groups, and (iii) testing environmental samples.

• Triangulation of micro data to identify clusters of disease to update containment measures, as done in Japan and the Republic of Korea, as well as in Dharavi a large slum in Mumbai, India, Kerala, and Karnataka two southwestern states of India.

• Effective contact tracing in lowering positive testing rates in the Indian states of Assam, Himachal Pradesh, Karnataka, Kerala, Uttarakhand, and Haryana, and complementing digital contact tracing with tracing by trusted frontline workers, local governments, self-help groups, private practitioners, and civil society stakeholders.

• Partnering with the private sector to address supply chain bottlenecks for test kits and reagents; and introducing new technologies (such as TrueNAT) to improve testing access for rural underserved populations and antigen tests for point-of-care diagnosis in dense urban containment zones (as done in Delhi)

3. Optimize COVID-19 testing capacity without negatively impacting ongoing disease control programs. India’s COVID-19 testing response rightly leveraged the existing testing platforms for tuberculosis (TB) and, to a limited extent, human immunodeficiency virus (HIV). It is, however, important to ensure that diagnostic capacity built over the past decade for these priority public health diseases is balanced with the sudden increase in demand for COVID-19 testing. The Ebola outbreak in West Africa demonstrated the importance of taking measures to protect existing disease control programs during epidemics.

4. Effectively tracking COVID-19 while preparing for future pandemics. To better prepare for future pandemics, India must expand testing infrastructure, especially in states where capacities are weak; create a competent public health workforce at district and subdistrict levels for disease prevention, surveillance, and contact tracing; clarify roles and responsibilities of key institutions; and establish a legal framework for digital contact tracing to ensure privacy.

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PART II – INTRODUCTION The COVID-19 pandemic is the world's most severe human health tragedy of this century. The pandemic has ravaged the global economy and slowed ongoing efforts to eliminate extreme poverty. Globally, COVID-19 is expected to push an estimated 70 million people into extreme poverty (World Bank 2020), 42 million of those would be from South Asia, with the largest share from India. Despite increasing recoveries and lowering death rates, as of July 15, 2020, India ranks third in the world in absolute number of COVID-19–positive cases reported. India's first reported case of COVID-19 on January 30, 2020, originated in China. The government of India’s (GOI) prompt response slowed the exponential spread of the epidemic. On March 24, 2020, the prime minister ordered a nationwide lockdown for 21 days, which was subsequently extended three more times (on April 14, May 1, and May 17) through May 31, 2020. The initial lockdowns undertaken across the globe helped many countries, including India, to better prepare their health systems to handle the rapidly evolving pandemic. However, steep increases in COVID-19 case numbers, coupled with chronic underinvestment in health and fallout from hard-hit economies, impacted lives of the poorest and most vulnerable segments of India’s population. With the exodus of millions of suddenly unemployed migrants returning to their rural homes, the pandemic—hitherto confined mostly to urban India—spread to rural areas as well, where health systems are much weaker. This movement of migrants from cities to labor-exporting states rendered the challenge of testing and contact tracing more complex. As lockdowns are lifted in a phased manner and economic activities are revived, policy makers must make smart choices that rein in the spread of COVID-19. In the absence of effective treatment or a vaccine, preventive measures1 combined with testing and tracing, followed by quarantine/isolation and supportive treatment, are critical to minimize the spread of COVID-19 and help rejuvenate livelihoods and the economy. Several innovations are being tried within India and globally to optimize the impact of testing and tracing. Taking these innovations to scale requires detailed analysis of available knowledge to distill key factors contributing to enhanced testing efficiency and optimized strategies for contact tracing. This note brings together promising approaches from India and globally on use of testing and tracing, combined with prevention, as a key strategy for containing COVID-19. It documents lessons from previous outbreaks (such as of severe acute respiratory syndrome [SARS]) and infectious disease control programs (tuberculosis [TB] and polio), as well as evolving evidence on COVID-19. This note also summarizes innovations—and bottlenecks—to rapidly scale up testing capacities at the state level, including strategies for optimizing the role of the private sector and introducing new technologies to enhance access to rural populations. Target audiences for this note are key policy makers and program managers at national and state levels. The note offers options relevant to the Indian context, with a focus on sustained health systems strengthening. This paper is organized into six sections. The first two sections (Limitations and Epidemiology) describe the context of COVID-19 in India. The next two sections (Testing and Tracing) detail Indian and global experiences and distill key lessons. The fifth section focuses on vulnerable groups, while the sixth section presents immediate and medium-term options for scaling up testing and tracing, based on evolving lessons.

1. Physical distancing, use of masks, and hand hygiene.

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PART III – LIMITATIONS Despite a wealth of knowledge accumulated over the past few months, COVID-19 is still a new disease characterized by many unknowns. Existing knowledge from successful infectious disease control programs such as for TB2 and polio3 is relevant. However, this knowledge requires appropriate adaptation for this novel coronavirus. In the absence of robust randomized trials and research, most policy decisions on COVID-19 containment are still based on modeling techniques used for earlier pandemics and evolving experiences from countries in their first wave. This paper is based on the situation in India through mid-July 2020 and does not capture subsequent unfolding of the pandemic in India, nor the commendable progress the country has made in scaling up testing. Considering the wide variation in population characteristics within India, and among its states’ health systems capacity, responsiveness, and ways governments function, it is difficult to generalize emerging lessons.

2. Identify and treat infective persons, and use innovative technology to test drug resistance on-site at district/subdistrict–level laboratories. 3. Strong syndromic surveillance at district level, efficient use of hub-and-spoke model with swift specimen transportation to reference labs and sewage sample testing for wild virus circulation in environment.

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Figure 1: Distribution of States by Positive Tests (Percent)

PART IV – EPIDEMIOLOGY As of July 15, 2020, the Ministry of Health and Family Welfare (MOHFW) had confirmed a total of 936,181 positive cases, 592,031 recoveries, and 24,309 deaths due to COVID-19 in India. Despite having the largest number of confirmed cases in Asia, India's mortality rates remained low at about 2.8 per 100,000 population. Two states (Maharashtra and Tamil Nadu) and National Capital Territory (NCT) of Delhi accounted for more than half of the cases; five out of every ten cases reported were from eight cities: Delhi, Mumbai, Chennai, Thane, Pune, Hyderabad, Ahmadabad, and Bangalore. However, with the reverse migration of workers to their home states, the disease is spreading to rural areas, with steady increases in the labor-exporting states of Bihar, Uttar Pradesh, West Bengal, Assam, Chattisgarh, and Jharkhand. The Indian Council of Medical Research (ICMR) provided a comprehensive descriptive epidemiology covering time, place, and person for 1,021,518 individuals tested for COVID-19 between January 22 and April 30, 2020 (ICMR COVID Study Group 2020). The median age of cases was 37 years, with nearly three-fourths of cases in the age group of 20 to 59 years. Two-thirds of confirmed cases were men, and the most common presenting symptoms were cough (64.5 percent), fever (60.0 percent), breathlessness (31.9 percent), and sore throat (26.7 percent). Attack rate (per million population) was the highest among those age 50–59 and 60–69 (64.9 percent and 61.8 percent, respectively) and was lowest among those under 10 years old (6.1 percent). The highest test positivity rates were noted among symptomatic contacts of laboratory confirmed cases (10.3 percent), followed by hospitalized persons suffering from SARS (6.1 percent) and asymptomatic direct contacts (5.1 percent). Among states, highest positivity rate was observed in Maharashtra followed by NCT of Delhi, Gujarat, and Madhya Pradesh (Figure 1).

Source: ICMR Covid Study Group; Laboratory surveillance for SARS-CoV-2 in India: Performance of testing & descriptive epidemiology of detected COVID-19, January 22 - April 30, 2020; Indian J Med Res, Epub ahead of print DOI: 10.4103/ijmr.IJMR_1896_20

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PART V – TESTING

COVID-19 testing involves analyzing samples to assess the current (virus) or past (antibodies) presence of SARS-CoV-2 virus. Tests for viral presence include Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and antigen tests. Real Time RT-PCR is considered the gold standard for diagnosis of COVID-19, and India is currently using both open and closed systems of RT-PCR platforms (open system RT-PCR machines and TrueNAT and CBNAAT, also popularly known as GeneXpert). India recently introduced antigen testing to ramp up testing in containment zones for point-of- care diagnosis. Despite lower sensitivity compared to RT-PCR platforms, the antigen test helps to promptly diagnose individual cases and allows public health authorities to trace and contain outbreaks. ICMR guidelines specify that all symptomatics who test negative for antigen tests should be subjected to an RT-PCR test. Antibody tests show whether someone had the disease in the past and thus help in the study of disease prevalence and trends and in estimation of the infection fatality rate. More information on these tests is presented in Annex 1.

WHY IS TESTING SO CRITICAL? Testing is a core element of controlling spread of infectious diseases. Testing helps in identification of infection, and subsequent treatment/isolation prevents further spread. Recent progress made in TB and polio control/eradication is largely due to systematically improving access to quality laboratory services for diagnosis. Evolving global evidence on COVID-19 shows that countries that fail to test large or representative portions of their population find it extremely difficult to assess the scale of infection and to estimate health resources required to effectively respond. The case of Bergamo in Italy, where the virus circulated undetected for weeks, is a case in point. A comparison of the town of Vo’ in Italy and the Diamond Princess Cruise Ship—which had a comparable number of people and implemented a similar isolation process—serves as a natural experiment (Ricciardi, Verme, and Serajuddin 2020). Despite having a higher number of cases initially, Vo’ finally ended up having only six cases compared to 712 (Table 1) on the Diamond Princess. However, it is neither practical nor possible to test everyone.

Table 1: Comparison of Two Testing Approaches Parameters Vo’ Italy Diamond Princess

Population 3,305 3,711 Test approach Census Suspicious cases Cases (1st test) 87 10 Infection rate (1st test) 2.6 0.3 Policy Isolation of all cases Isolation of all cases Cases (final test) 6 712 Infection rate 0.2 19.2

Source: Ricciardi, Verme, and Serajuddin 2020

Republic of Korea (population of 51.5 million) learned a harsh lesson about the cost of delayed action from the Middle East respiratory syndrome (MERS) in 2015, which killed 36 people, infected 186, and forced thousands into quarantine in an outbreak that was traced to a single visitor from overseas. Korea quickly developed the capability to test an average of 12,000 people (sometimes as many as 20,000) a day at hundreds of drive-through and walk-in testing centers. The mobile centers conducted the tests free of charge within 10 minutes, and results were sent to people’s phones within 24 hours. By mid-March more than 270,000 people had been tested (McCurry 2020). This helped the country to aggressively flatten the COVID-19 curve without massive lockdowns.

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Source: US Centers for Disease Control and Prevention; May 3, 2020

The rapid containment of the SARS outbreak by Singapore (population of 5.6 million) in 2003 involved the introduction of several stringent control measures. These measures had a profound impact on the health care system and community and were associated with significant disruptions to normal life and business. Singapore’s wide-net surveillance, isolation, and quarantine policy was effective for early isolation of probable SARS cases. However, it resulted in nearly 8,000 contacts being put on home quarantine and 4,300 on telephone surveillance, with 58 individuals ultimately being diagnosed with probable SARS. Having a rapid and highly sensitive test for SARS infection would have substantially reduced the number of individuals that needed to be quarantined, without decreasing the effectiveness of the measure (Tan 2006). WHO SHOULD BE TESTED? According to US Centers for Disease Control and Prevention (CDC), SARS-CoV-2 can cause asymptomatic, presymptomatic, and minimally symptomatic infections, leading to viral shedding that may result in transmission to others who are particularly vulnerable to severe disease and death. Even mild signs and symptoms (e.g., sore throat) of COVID-19 should be evaluated among potentially exposed health care personnel, due to their extensive and close contact with vulnerable patients in health care settings. The most recent CDC-recommended criteria (presented in Box 1) distinguish high-priority and priority cases. CDC guidelines provide considerable flexibility to local health departments and clinicians to test persons without symptoms. The update of June 25, 2020, also lists people at increased risk of severe COVID-19 disease.

In India, the National Task Force on COVID-19 testing constituted by the ICMR issued its first advisory on March 9, 2020. This is being reviewed and updated periodically. The latest testing advisory (Version 5, dated May 18, 2020, Box 2) targets symptomatic (i.e., symptoms of influenza-like Illness or ILI) individuals with history of

Box 1: Priorities for COVID-19 Testing (Nucleic Acid or Antigen)

Box 1: ICMR Testing Strategy

Source: Indian Council of Medical Research, Strategy for COVID-19 testing in India (Version 5, 18 May 2020) Notes: ILI = Influenza-like illness; SARI = Severe acute respiratory infection.

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international travel, symptomatic contacts of confirmed cases, symptomatic health care and frontline workers, patients with severe acute respiratory syndrome (SARS), symptomatic cases in hot spots and containment zones, hospitalized patients who develop symptoms, symptomatic returnees, and migrants within seven days of onset of illness and asymptomatic direct and high-risk contacts of confirmed cases between 5 and 10 days of coming in contact. The ICMR further updated its strategy on June 23, allowing the use of COVID-19 antigen kits in containment zones, government facilities, and accredited private facilities registered with the ICMR.4 These guidelines clearly recommend that all COVID-19 symptomatic negative for the antigen test should be followed up with RT-PCR. The ICMR also provided guidelines for possible groups to be tested for serological surveys.5 Considering the complex nature of this pandemic and its ongoing spread from densely populated cities to rural areas, testing criteria should allow flexibility for customization based on local needs. However, strong oversight will be required; some states have tried to interpret these guidelines in ways that allow them to save on costs and ended up with steep increases in cases. STRONG PROGRESS, YET MORE TO DO The ICMR led India’s phenomenal progress in testing, despite initial limitations in reference laboratory capacity (78 labs) and global shortage of reagents. To rapidly expand India’s testing capacity, the ICMR issued guidelines for the participation of private sector laboratories on March 21, 2020. As of July 15, 2020, 392 government labs and 243 private labs were performing open RT-PCR tests for screening COVID-19. In addition, the ICMR approved cartridge-based COVID-19 tests, currently available at 447 government and 52 private labs, and 35 government and 65 private facilities, respectively for TrueNAT and CBNAAT.6 These closed cartridge-based tests—that allow point-of-care testing and carry lower risk of biomedical hazards—help to improve access for people residing in more remote areas, especially those receiving migrants (Table 2). Table 3 provides a comprehensive summary of approved COVID-19 tests in India.

4. Antigen (Ag) test to be done at containment zones and hotspots for all symptomatic and asymptomatic high-risk contacts; health care setting—all ILI cases, asymptomatic cases undergoing chemo, treatment for HIV, transplants, elderly with comorbidity; asymptomatic patients undergoing aerosol procedures in—neurology, ear nose and throat (ENT), gastrointestinal (GI) endoscopy, dialysis. 5. Possible groups for antibody test (IgG) to be done for immuno-compromised patients – HIV, TB, dialysis, COPD, SARI; individuals in containment zones; health care workers; security personnel, police, press corps, paramilitary; rural, tribal population after reverse migration; industrial workforce; farmer vendors visiting large markets; staff of municipal bodies; drivers; bank, post office, telecom, courier offices; shops, air travel–related staff; international operations; congregate settings— slums, old age homes, orphanage, asylums, prisons, etc. 6. Cartridge-based Nucleic Acid Amplification Test.

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Table 2: ICMR Strategy to Rapidly Expand Laboratory Network for COVID-19 Testing

Source: Indian Council of Medical Research testing strategies and approved COVID-19 testing laboratories (https://www.icmr.gov.in/cteststrat.html)

Table 3: COVID-19 Tests Approved in India Description RT-PCR Closed Molecular

Diagnosis (TrueNat/ CBNAAT)

Antigen test Antibody test

How does it work

Detects current infection—replication of viral RNA

Detects current infection—replication of viral RNA

Detects current infection—viral proteins

Detects past infection (immune response-IgG or IgM)

Sample type

Nasopharyngeal, nasal or oropharyngeal swab

Nasopharyngeal, nasal or oropharyngeal swab

Nasopharyngeal, nasal or oropharyngeal swab

Finger prick blood/ venous blood

Time taken 6–8 hours 2 hours 30 min–1 hour 30 min–1 hour Sensitivity 71–98% TrueNat: 100%

CBNAAT: 95.8% 50-80% Varied 56–100%

Specificity 98.8% TrueNat: 100% CBNAAT: 99.5%

100% Varied 90–100%

Role Diagnostic (Confirmation of active infection)

Diagnostic (Confirmation of active infection)

Diagnostic (Confirmation of active infection) —Negative test requires RT-PCR reconfirmation

Surveillance and research purpose

Source: www.finddx.org/wp-content/uploads/2020/05/FIND_COVID-19_RDTs_18.05.2020.pdf https://en.wikipedia.org/wiki/COVID-19_testing

March April May June • Reserved

testing • Expansion of testing

with molecular methods and private sector

• Expansion of testing and reintroduction of antibody testing

• Introduction of rapid antigen test

• Mainly symptomatic travelers and contacts

• Symptomatic testing • Antibody testing

introduced • TrueNat for

screening introduced

• Pooled sample for TR-PCR introduced

• Symptomatic migrants, hospitalized patients added

• Returnee migrants • Antibody tests

reintroduced for special settings

• TrueNat and CBNAAT allowed for confirmation

• Testing capacity ramped up

• Rapid antigen testing added in addition to the earlier test

• Antigen tests allowed in containment zones and health care settings

• Private sector not yet roped in

• Private sector slowly introduced

• Private sector participation increased

• Private sector participation increased

• 126 labs for testing

• 321 government labs

• 118 private labs (as of May 5, 2020)

• 874 government labs • 360 private labs (as

of July 15, 2020)

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Figure 4: Comparison of Daily and Cumulative Test Positivity in Selected Countries

Source: Worldometer – www.worldmeters.info

IS INDIA TESTING ENOUGH? In absolute numbers, the United States has conducted more COVID-19 tests than any other country. In terms of number of daily tests, India now stands second in the world (Figure 2). According to the MOHFW, India was conducting 201 tests per million population as of July 14, 2020. The GOI advised states to scale up testing to 140 tests per day per million population, which is considered by the WHO as comprehensive testing volume. Currently, 22 states are meeting this benchmark, acco rd ing t o the data shared by the MOHFW (Figure 3).

Source: Worldometer – www.worldmeters.info Source: MOH data from PTI on July 14, 2020

There is no expert consensus on a recommended target for the rate of tests per capita. Also, there is wide variation in how countries report testing data, which makes comparison difficult. Therefore, looking at the positivity rate (i.e., how many COVID-19 positives of all tests conducted) is the most reliable way to determine if a government is testing enough. A high rate of positive tests indicates that a government is only testing the sickest patients who seek out medical attention and is not casting a wide enough net.

WHO guidance recommends that governments should see positivity rates below 5 percent for at least 14 days before relaxing social distancing measures. Figure 4 presents global test positivity data compiled by Johns Hopkins Coronavirus Resource Center based on data available on July 15, 2020. While overall test positivity for India is estimated to be 8.7 percent, there are wide variations across states.

Figure 2: Daily New COVID-19 Tests Figure 3: States Performing More Than 140 Tests per Day (per Million Population)

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Available data on state-level test positivity as of July 12, 2020 shows wide variations in daily positivity rates and cumulative test positivity (Figure 5). Kerala and Punjab sustained low levels of test positivity. Aggressive testing in containment zones using a combination of antigen and RT-PCR tests seems to have helped Delhi to decrease test positivity. Maharashtra and Tamil Nadu continue to have high test positivity; however, steep increases in positivity rates in Telangana, Karnataka, and Andhra Pradesh are a cause for concern. There is also increased test positivity among the labor-exporting states of West Bengal, Orissa, and Bihar, suggesting spread of pandemic to rural areas7.

Source: www.covid19india.org

Indian states are increasingly using micro-data to inform their COVID responses. Local lockdowns were imposed by several states based on locale-specific data. Central and state governments came together to scale up testing in Delhi by three times and introduced antigen testing in containment zones. By June, Delhi reported almost daily record surges in COVID-19 cases, which overran capacity of labs and public hospitals, creating chaos and anxiety. By the end of the month, Delhi responded with a flurry of measures, from door-to-door health check-ups to increased testing and effective follow-up—including isolation and home-based care for mild cases and asymptomatic contacts, with the use of antigen tests. Despite the lower sensitivity of antigen tests, these efforts seem to be paying off. Delhi's daily case count has been dropping sharply, even as testing remains consistent. By mid-July Delhi recorded 1,200 to 1,600 new cases a day—about half of its daily count during the last week of June, when it was reporting more than 3,000 new cases a day. Delhi's reported COVID-19 daily deaths have fallen from 62 at the end of June to 41 by mid-July. It has now dipped below even Tamil Nadu, which has consistently reported fewer COVID-19 deaths than Delhi or Maharashtra since the pandemic began. According to Professor K. Srinath Reddy, president of the Public Health Foundation of India, "There is more emphasis on public health, more household visits, more testing, better public communication. The public alarm helped, and there is a lot more energy in the system, and much better coordination between the center and the state." (BBC 2020)

District-level data in Maharashtra showed that more than 50 percent of new cases reported in 15 out of 33 districts are from returning migrants or their close contacts. It is therefore important to promote such locale-specific data analysis and response, since factors contributing to pandemic spread are different across as well as within the states.

7. https://indscicov.in/for-scientists-healthcare-professionals/

Figure 5: Comparison of Daily and Cumulative Test Positivity in Selected Indian States

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Figure 6: States Optimizing Testing Capacity Figure 7: States Underutilizing Testing

HOW TO OPTIMIZE TESTING? Several innovations are being tried within India and globally to optimize testing. Below is a summary of these approaches, which include pooled testing, partnering with the private sector, use of molecular diagnostics for nucleic acid amplification, environmental sampling, and use of hub-and-spoke approaches. Optimizing existing capacity: During the lockdown period, the GOI made tremendous effort under the leadership of the ICMR to ramp up the existing laboratory network for COVID-19 testing, as well as domestic production of test kits. We estimate (as of July 15, 2020) that if the full potent ial of current laboratory capacity is used, India should be able to perform close to 335,000 tests per day. We estimated potential for fully utilizing existing capacity compared with maximum tests that could be done in a day with average number of tests being done (elasticity of the system). While many states are increasingly utilizing the full potential of expanded laboratory capacity (Figure 6) some states are still lagging behind (Figure 7).

Source: www.covid19india.org Notes: AP - Andhra Pradesh; AS- Assam; CT – Chhattisgarh; PJ – Punjab; KL – Kerala; HR – Haryana; BH – Bihar; GO – Goa; JH – Jharkhand; PY – Puducherry; TS – Telangana; UK – Uttarakhand; HP – Himachal Pradesh; OR – Odisha; WB – West Bengal; MH – Maharashtra Partnering with the private sector. Global evidence suggests that an effective pandemic response requires a whole systems approach, pooling all available resources from public and private sectors. Iceland is an excellent example of preparedness and partnership with the private sector—with clear segregation of roles—to quickly ramp up testing. Iceland had already been updating and testing its response to a global pandemic since 2004. When hit by COVID-19, Iceland's testing capacity was helped by a bio-pharmaceutical company, Decode Genetics, which quickly teamed up with health authorities to ramp up public testing. Over six weeks, Iceland managed to test almost 50,000 people—more than 13 percent of its population, the largest proportion covered by any country during the early phase of the COVID-19 pandemic. People already feeling sick or in quarantine were tested in hospitals, while Decode used its facilities to test a cross-section of the population, identifying scores of new cases, including people with mild or no symptoms (Bjarnason 2020). India also quickly leveraged the capacity of private sector laboratories to boost testing capacity. The ICMR issued notification for private laboratories early on March 21, 2020. As of July 15, of 1,234 total laboratories approved by the ICMR for COVID-19 testing, nearly a third (360) were private sector labs. However, the share of tests done by private sector labs appears to be low (about a fifth) and has varied across states. To what extent the variance is due to price, state-specific approach (some states initially limited testing to public sector), initial national guidelines (e.g., every positive sample needs

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Capital costs: This incudes costs of equipment, biosafety requirements, initial consumables, infrastructure, and initial training. The total capital cost was then converted to annualized cost, assuming a five-year life cycle for equipment. The annualized cost was again converted to daily capital cost assuming 300 working days in a year and unit capital cost, taking into consideration throughput for each method as shown below: - RT-PCR: 140 tests per a six to eight–hour shift, and we assumed two shifts in a day, yielding a total

output of 280 tests/day. The cost and output will vary by type of equipment used - TrueNAT: Five test runs of four tests in a six to eight–hour shift, yielding an output of 32 tests/day Recurring costs: This includes cost of kits, sample collection, transport, reagents, lab consumables, biosafety requirements, and technician time. For quality assurance the Kerala model of three positive and negative, each twice a month, was used.

Estimated Unit Costs:

Open RT-PCR and GeneXpert Rs 3,000 TrueNat Rs 2,000

reconfirmation by National Institute of Virology [NIV] Pune), or other logistics issues needs to be studied further. We have estimated unit costs of all three methods of RT-PCR tests approved by the ICMR (Annex 2). We included both capital and recurring costs to arrive at total costs, which is summarized in Box 3, including assumptions used. There are also huge capital costs for RT-PCR, which limits its expansion in poorer states. Therefore, the pricing issue needs to be addressed nationally, especially with the inclusion of COVID-19 testing and treatment under the GOI’s flagship health insurance program, the Pradhan Mantri Jan Arogya Yojana (PM-JAY).

Source: Authors estimates

A Center for Global Development report also argues that criterion used for selecting private laboratories—that they need National Accreditation Board certification specifying real-time PCR for RNA—are more stringent compared to guidelines for public laboratories, which affects involvement of the private sector (Yadav et al. 2020). Some states like Andhra Pradesh used innovative approaches to address such constraints. The government gave space in public centers to private labs not authorized to conduct tests. The private labs shifted their equipment and provided additional staff to enhance testing by these government facilities.

The GOI also partnered with the private sector to enhance local production of diagnostic material. Now three Indian companies manufacture more than 200,000 swabs per day, and production of viral transport medium was dramatically scaled up from 500,000 units per year to 500,000 units per day. Out of the 53 RT-PCR kits found to be satisfactory by ICMR by June 19, 21 are indigenous. Bigtec Laboratories of Bangalore developed a battery-operated portable micro-PCR device, TrueNat MTB, which is being used for TB diagnosis. Responding to urgent need to rapidly scale up access to COVID-19 testing, Molbio Diagnostics promptly developed a micro-PCR device to enable COVID testing by TrueNat machines (Sharma 2020). The ICMR recommended its use as COVID-19 screening test on April 4, 2020. There are about 1,800 TrueNat devices in India that are increasingly being used for COVID-19.

Box 3: Unit Cost for RT-PCR Tests

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With samples being collected in a viral lysis medium that inactivates the virus, the biosafety and biosecurity requirements are minimal for this approach. As the GOI redeploys many of these devices to boost laboratory capacity in districts receiving migrants, it is important to ensure that ongoing TB surveillance is not adversely affected. Doorstep delivery of these materials is being carried out in partnership with courier companies (ICMR 2020).

Sustaining such proactive engagement with the private sector requires better understanding of market forces depicted in F i g u r e 8 . Market uncertainties about pandemic progress and the evolution of new testing methods affect aggressive investments. The holding problem could be a result of slower-than-envisaged procurement, as witnessed by some states, coupled with export restrictions, which lead to stockpiling. Steep increases in tax-free imports could also contribute to this problem. Finally, if vaccine development happens earlier than envisaged, the industry has to suddenly stop production or find alternate uses for capital investments made for development of diagnostics kits and reagents.

Scaling Up pooled testing: Germany used a “pooled testing” approach to COVID-19 test a large number of asymptomatic people. Germany’s experience suggests that pooling of up to 30 samples per pool can increase test capacity with existing equipment and test kits and detect positive samples with sufficient diagnostic accuracy (Lohse et al. 2020). It was, however, cautioned that borderline positive single samples might escape detection in large pools. Rwanda also successfully used this approach and estimated that it could cut the cost of testing from US$9 to US$0.75 per person.

In an effort to snuff out future problems, Seoul Special City and the Korean Disease Control and Prevention Agency (KDCA) are currently expanding pooled testing to facilities where they perceive a high risk of rapid contagion, such as care homes and crowded university dormitories. Under this approach, officials test about 5 to 10 people from the same facility at one time. If a single positive result is found, testing is quickly expanded to everybody at the site. The system was successfully used at several care homes in Daegu in April. Such pooled exercises could help in testing a much greater percentage of those people with the highest number of social contacts, such as delivery staff, vendors, and salon staff.

Based on a pilot study conducted in King George Medical College, Lucknow, Uttar Pradesh, the ICMR issued guidelines for pooled testing on April 13, 2020 for the purpose of COVID-19 surveillance in low-prevalence areas. These guidelines recommend five people be included in a pool and that pooled testing is carried out in areas with positivity of 2 to 5 percent for community survey or surveillance among asymptomatic individuals. Kerala used this approach for surveillance of asymptomatic health workers using a pool of 10 to 20 samples. Anecdotal reports suggest that other Indian states are also

Figure 8: Market Forces Affecting Private Sector Production

UNCERTAINITY

1. Pandemic progress 2. New technologies

HOLDING PROBLEM

1. Slow procurement 2. Export restrictions 3. Tax-free imports

HOLDING PROBLEM

Early development of vaccine

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using pooled sampling. As the country is opening up, the option of using pooled testing at periodic intervals for some high-risk asymptomatic spreaders (such as vendors, delivery boys, and barbers) and vulnerable population groups in containment zones (e.g., elderly and those with comorbidities) could be explored.

Exploring new molecular diagnostic techniques: Promising approaches that still need ICMR validation are being developed by Indian research institutions in partnership with the private sector. The Next Generation Sequencing (NGS) Kit developed by the Center for Cellular and Molecular Biology (CCMB) in partnership with Syngene is one such approach. This kit sequences several parts of the virus genomic material and thereby lessens the chances of inaccurate testing. By eliminating the need for isolation of RNA, this method reduces the time and cost, compared to that of the classical RT-PCR test. Moreover, this kit allows collection centers to pick large number of samples (up to 1,000) in a go, which makes it more practical for urban containment zones.

A new RT-Loop-mediated Isothermal Amplification (RT-LAMP)–based diagnostic kit was developed by the Council for Scientific and Industrial Research (CSIR) Jammu in partnership with Reliance Industries Limited. Similar technology was also developed by Harvard University, which filed a patent application (Rabe and Cepko 2020). This nucleic acid–based test is carried out from nasal/throat swab samples and uses synthetic templates. The test is rapid (takes 45 to 60 minutes) and can be carried out in a single tube with minimal expertise in a very basic lab set-up, like mobile units/kiosks, which makes is easy for testing at airports, railways stations, bus stands, and other public places. The advantage is easy availability of all components of this kit in India.

Use of the hub-and-spoke approach: In countries where viral laboratory resources are extremely constrained, the hub-and-spoke approach is generally used. India has been using this approach for polio surveillance. The speed of COVID-19 spread has challenged lab capacities even in high-income countries, and the ICMR has used this approach in India.

Experiences from the United Kingdom, however, raise concerns about over-centralization of laboratory networks in its National Health Service, which was ill-prepared for COVID-19 due to 10 years of austerity measures (Banatvala 2020). India could benefit from a modified hub-and-spoke model, focusing on geographic areas that have large clusters of cases (urban areas and home communities of migrants) to widen testing access at lower-level health facilities or mobile collection centers. Considering the huge capital cost implications of open RT-PCR machines, this approach could be an option for the private sector, especially in states where public health laboratory capacity is still evolving.

Introducing environmental testing: Environmental testing involves testing for viruses in sewers. This can be used as an early warning sign of community transmission before human testing is picking up cases. Environmental sampling can inform decisions to implement or relax public health measures and restrictions, and provide timely information on outbreak dynamics. A study of primary sewage sludge during the spring COVID-19 outbreak in a northeastern United States metropolitan area detected SARS-CoV-2 RNA in all environmental samples. When adjusted for the time lag, the virus RNA concentrations were highly correlated with the COVID-19 epidemiological curve (R2 = 0.99) and local hospital admissions (R2 = 0.99). SARS-CoV-2 RNA concentrations provided a seven-day lead, ahead of compiled COVID-19 testing data and led local hospital admissions data by three days (Peccia et al. 2020). India has been using this approach for polio, and pilot programs in Ahmadabad and Hyderabad suggest that this could easily be introduced for COVID-19 surveillance.

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Immunological observation: An innovative concept proposed by immunologist and epidemiologist Michael Mina involves watching for outbreaks by looking for antibodies to infectious agents in regularly collected, anonymized blood samples from every possible source: blood banks; plasma collection centers; even the heel needle sticks of newborns, which are taken to identify genetic diseases. This could be used as a surveillance strategy, and to ensure confidentiality, samples should only be identified only by geographical area. Chip-based platforms that can identify hundreds of thousands of antibodies, which are already being produced commercially by companies, can be used to identify any potential outbreaks. The Kenya Medical Research Institute (KEMRI)/Wellcome Trust developed indigenous Enzyme Linked Immunosorbent Assay (ELISA), validated with a panel from the World Health Organization (WHO). Between April 4 to June 6, 2020, 2,535 blood samples donated from several locations were tested and observed; their SARS-CoV-2 antibodies ranged between 1.1 percent (95% CI 0.6-3.5) to 12.4 percent (95% CI 7.8-19.0). Based on this, the KEMRI team estimated the population exposed, and compared that with actual number of cases being detected by testing and tracing done by the rapid response teams. The findings showed a large gap between confirmed cases and estimated exposures, highlighting the need to enhance testing and tracing (KEMRI/ Wellcome Trust 2020). HOW TO CREATE DEMAND FOR TESTING? Stigma and other sociocultural factors have a major impact on demand for testing. There are several reports of communities not coming forward for testing as well as refusing to provide accommodation to frontline workers due to fear of COVID-19 spread. There have also been instances of individuals providing wrong addresses and incorrect phone numbers. In addition to these social concerns, price barriers also affect utilization of testing offered by the private sector. Strategic risk communication by trusted leaders is critical to dispel rumors and enhance understanding. New Zealand’s Prime Minister Jacinda Ardern used this approach by clearly explaining that COVID-19 is not an unknown threat but a disease that can only be eliminated if every citizen complies with social distancing and hygiene practices and promptly reports at a health care facility when symptoms appear. Such communication needs to be reinforced, targeting specific high-risk groups (the elderly and those with comorbidities) by trusted local health workers, as Japan has done. With the inclusion of COVID-19 testing under India’s Pradhan Mantri Jan Arogaya Yojana (PM-JAY) health insurance scheme, financial barriers for the poor will be addressed. HOW TO ENSURE TEST QUALITY? The ICMR has established a network of institutions to validate different testing kits available in India. There is also a quality assurance system that includes private laboratories. Each private lab is mapped to a quality control lab and has to send random samples of 10 positive and 5 negative tests per month. The efficacy of RT-PCR (both open and closed), which is the main diagnostic tool for SARS-CoV-2 and antigen tests, could be affected at the operational level due to (a) carrying out tests either too early or too late, when viral load is less; (b) noncooperation of clients due to discomfort when swabs go deep into the throat; (c) failure to store tests at appropriate temperatures (2 to 8 degrees Celsius) or store beyond 72 hours without using deep freezers; and (d) using nonstandardized kits. Several serological tests are available to retrospectively identify COVID-19 infection. Their diagnostic accuracy, however, is quite variable, which makes comparisons difficult unless the same kit and methodology are used. Training and standardization of technical skills, as well as external quality control, are critical for all tests.

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PART VI – TRACING

WHY CONTACT TRACING IS CRITICAL? The CDC defines a contact as a person who has spent at least 15 minutes within six feet of a COVID-19 case starting two days before that person gets sick. Effective contact tracing is a critical contributor of the early successes achieved by Kerala and Korea. In Korea, people who tested positive were asked to describe their recent movements, aided by GPS phone tracking, surveillance camera records, and credit card transactions. Those details enabled the KDCA to issue alerts, in real time, about where infected people had been before their positive status was confirmed. As lockdown measures are relaxed in a phased manner, effective containment of the pandemic by India will be possible only when all contacts of index cases are identified rapidly before they have a chance to infect others. Findings from the ICMR study summarized in the graph below (Figure 9) show that states that carried out better tracing and testing of symptomatic contacts and asymptomatic family members generally had lower case positivity rates (Himachal Pradesh, Karnataka, Uttarakhand). Delhi, Maharashtra, Gujarat, and West Bengal carried out relatively low levels of contact tracing compared to the national average (six per case) and had higher test positivity rates. Figure 9: Contact tracing and test positivity in selected Indian states and Delhi(Percent)

Source: ICMR Covid Study Group; Laboratory surveillance for SARS-CoV-2 in India: Performance of testing & descriptive epidemiology of detected COVID-19, January 22 - April 30, 2020; Indian J Med Res, Epub ahead of print DOI: 10.4103/ijmr.IJMR_1896_20

Asymptomatic contacts could remain so or may begin to show symptoms after the incubation (presymptomatic) period. On average, an infected person begins showing symptoms five days after becoming infected (the incubation period) and begins infecting others two to three days before symptoms appear (He et al. 2020). An estimated 44 percent of viral transmissions occur within this period. In addition to this, a significant number of infected people never show symptoms but are nevertheless contagious (Healthline 2020). Therefore, if transmission of this disease is to be blocked effectively, people must be tested and isolated before they begin to show symptoms. Like testing,

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success of contact tracing is directly linked to quarantine, isolation, and treatment protocols.

WHAT INNOVATIONS CAN IMPROVE TRACING?

Several innovations in contact tracing are being tried within India and globally, which could broadly be grouped under two categories: traditional approaches and digital methods. Most countries use a combination of these methods. TRADITIONAL METHODS OF CONTACT TRACING China managed to contain COVID-19 effectively using a combination of containment and suppression measures. Other countries that successfully contained COVID-19 with case identification and close-contact identification and management include Iceland, Mongolia, Singapore, Korea, and Vietnam (Zhongjie et al. 2020). The core intervention in these countries has been timely detection and management of suspected and confirmed cases and identification and management of close contacts. Singapore maximized detection of suspected patients through a public prevention clinic network and tightly implemented home quarantine for patients with mild illness. Korea greatly expanded the scope of testing early by establishing more than 600 screening sites collecting COVID-19 samples for RT-PCR, including public health care clinics, drive-through centers, and walk-in screening sites. Japan effectively used traditional methods of contact tracing using a two-pronged approach (Saito 2020): • Optimizing the use of existing public health infrastructure: Japan is fortunate to have

469 local public health centers with more than 25,000 staff, who worked hard to conduct contact tracing even before the virus became prevalent in the country. With no tracing apps (given patients’ reluctance to disclose full information), contact tracing involved calling patients and politely asking them to name the people they had met with in the last fortnight. The system has worked well.

• Cluster-focused approach: Japan at an early stage identified that efforts to find cases through testing those who had contact with patients was not particularly effective. While many patients do not infect anyone, some infect many, thereby forming “clusters” of infected people from a single source. Therefore, in addition to contact tracing, Japan focused on a retrospective tracking of links between patients and found unrecognized cases surrounding the possible source, thereby identifying clusters that enabled the government to provide the public with an effective early warning.

A partnership between the state of Massachusetts in the United States with Partners in Health (PIH) involved designing and implementing a robust contact tracing program for the state. The governor dedicated US$40 million for this initiative. The key innovation was to divide contact tracers into three specific job categories: (a) case investigators, who quickly call people who test positive to interview them extensively about their contacts; (b) contact tracers, the largest group, who call each of the contacts and ask them to isolate for 14 days—and then follow up frequently for development of symptoms; and (c) care-resource coordinators, who are essentially social workers who help people in isolation/quarantine to solve problems related to food, housing, and management of addictions (Wallace-Wells 2020).

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Within three days of the first positive case, by March 22, the Health Department and the district administration in Bhilwara constituted nearly 850 teams and conducted house-to-house surveys at 56,025 houses and of 280,937 people.

• Nearly 2,250 people were identified to be suffering from influenza-like illness (ILI) symptoms and were kept in home quarantine. Intense contact tracing was also carried out of those patients who tested positive, with the Health Department preparing detailed charts of all the people whom they had met since being infected.

• A list of 498 people from five states Himachal Pradesh, Madhya Pradesh, Rajasthan, Uttar Pradesh, and Gujarat—was compiled by March 22. These were patients who had visited the hospital for treatment since the time when the staff got infected.

• By March 26, 6,445 people who were suspected of infection were kept in home quarantine. Official documents show that in the next five days—between March 22 and 27—435 thousand houses and 2.2 million people of Bhilwara, which has an estimated population of 3 million, were surveyed.

The state health department also took incorporated technology, using an app to monitor the conditions of those under home quarantine on a daily basis, along with keeping a tab on them through a geographical information system (GIS). The administration backed up the surveys by imposing a total lockdown on the district, with the local police ensuring strict implementation of the curfew. The frequency of cases went down after March 30, and on March 31, for the first time since the outbreak, the district, completely cordoned off from all communication, didn’t report a single case on March 31.

Box 4: Bhilwara Model

Excellent contact tracing strategies within India are well-documented by researchers and media. Rajasthan effectively used a strict containment strategy in Bhilwara (Box 4) to undertake census and identify persons suffering from influenza-like illness and those with travel history. This was followed by testing, home quarantine of suspected cases, testing, and contact tracing (Mukherjee 2020). Kerala8 established its control room and started screening, testing, and isolation and quarantining of travelers in all four international airports by January 2020, when COVID-19 was still confined to China. The contact tracing machinery published detailed route maps of people who tested positive via social and conventional media, which helped to recognize potential contacts early. A sample route map is presented in Figure 10.

Source: Deep Mukherjee; Explained: The ‘Bhilwara Model’ of ‘Ruthless Containment’ to Stop the Coronavirus.

8. https://medium.com/@aswathithandassery/lessons-from-the-3rd-world-how-kerala-a-small-state-in-india-

fought-and-almost-won-the-9059279c5ee6

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Figure 10: Early Introduction of Effective Contact Tracing, Testing, and Isolation Are an Important Part of Kerala’s Response to COVID-19 Pandemic

Source:https://medium.com/@aswathithandassery/lessons-from-the-3rd-world-how-kerala-a-small-state-in-india-fought-and-almost-won-the-9059279c5ee6 Rigorous planning also meant that by the time the first case was reported (traveler from Wuhan), 12 laboratories were already set up across Kerala for testing, and 20 percent of hospital beds were earmarked for COVID treatment and isolation. Rigorous monitoring and isolation helped to curtail community spread. The effectiveness of these measures is illustrated by the fact that at one stage, 5 percent of the state's population was under home or hospital isolation. DIGITAL CONTACT TRACING Digital contact tracing, especially if widely deployed, may be more effective than traditional methods of contact tracing. Numerous applications were developed or proposed with official government support in some territories and jurisdictions. Several privacy concerns have been raised, especially about systems that are based on tracking the geographical location of app users. While GPS-based tracking programs provide data to a centralized server that allows effective analysis and response, less intrusive alternatives include the use of Bluetooth signals to log a user's proximity to other cellphones. On April 10, 2020, Google and Apple jointly announced that they would integrate functionality to support such Bluetooth-based apps directly into their Android and iOS operating systems. Republic of Korea has one of the best contact tracing records in the world. When a person tests positive, a team of two investigators immediately begins contact tracing. They go to the scene and check CCTV footage and investigate whom the patient was in contact with and promptly have them tested and placed under self-quarantine. If those people test positive, the investigators start contact tracing again. This cycle of contact tracing is usually finished within a day.

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The app has four functions:

• User status (informs users of their risk of getting COVID-19) • Self-assess (helps users identify COVID-19 symptoms and their risk profile) • COVID-19 updates (gives updates on local and national COVID-19 cases) • E-pass integration (If applied for E-pass, it will be available)

The app provides information on how many COVID-19 positive cases are likely in a radius of 500 meters, 1 kilometer (km), 2 km, 5 km, and 10 km from the user. The app is built on a platform that can provide an Application Programming Interface (API) so that other computer programs, mobile applications, and web services can make use of the features and data available in Aarogya Setu. Recently the source code of the app was made public and a bug bounty program was launched to promote security and integrity.

Box 5: Aarogya Setu

The teams have identified and managed about 100 separate flare-ups or clusters and tested more than one million people since February (Jung-a et al. 2020). The key clusters include churches—starting with Shincheonji Church, which contributed to nearly 40 percent of cases reported as of July 2, 2020—night clubs, hospitals, nursing homes, and table tennis centers. Information on clusters is disclosed in the KDCA press releases every day (Figure 11). Figure 11: Regional Distribution and Epidemiological Links of Covid-19 case clusters in selected regions of South Korea

Source: Author’s analysis based on data disclosed by KDCA India's COVID-19 tracking app Aarogya Setu (Box 5) became the world's fastest-growing application with 50 million users in the first 13 days of its release on April 2, 2020. Source: https://en.wikipedia.org/wiki/Aarogya_Setu

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Source: https://www.deccanherald.com/state/top-karnataka-stories/contact-tracing-24x7-coordination-close-watch-on-the-quarantined-in-covid-19-war-room-in-karnataka-836531.html Several Indian states also introduced innovative digital contact tracing approaches; we provide a summary of such initiatives in Karnataka (Box 6) The GOI and several Indian states have also developed digital approaches to respond to the COVID-19 pandemic, which, in addition to contact tracing, facilitate online laboratory information systems, hospital bed availability tracking, mobile-based access to ambulance services in partnership with ride-hailing companies, help-lines, etc. Digital contact tracing approaches/platforms can be classified under three broad categories, according to Jeffry Kahn, who leads the Johns Hopkins Project on Ethics and Governance of Digital Contact Tracing Technologies (Kahn 2020):

(a) Maximal approach (such as in Korea) involving centralized and triangulated data collection

(b) Minimal approach (typified by the Apple/Google decentralized privacy-preserving proximity tracking [PPPT] and contact notification)

(c) Middle-ground approaches that augment manual contact tracing with the collection of digital data that can be shared with public health authorities.

The Johns Hopkin’s project recommends the following key parameters for digital contact tracing:

• This is no one-size-fits-all approach, and technology design should be dynamic and capable of evolving depending on local conditions, new knowledge, and technologies.

• Technology companies alone should not be controlling the terms, conditions, and capabilities.

• The Balabrooie Guesthouse in the city now functions as the state COVID-19 War Room to give a single point of all data, IT, and coordination at the state level to mount the fight against COVID-19. It informs citizens and guides field teams through its IT and data management system. It works 24/7 and in two shifts and has a team of 25 who work from the location and another 40 working remotely.

• A cloud-computing network enables digital data movement between the War Room and other sources and nodes of information, including district administration offices and the health department. The focus is on identifying those who are likely to infect and get infected, and then giving citizens the best possible information.

• At the crux of the efforts lie six categories: COVID-19 patients, primary and secondary contacts, migrant workers, healthy individuals, vulnerable individuals, and those under or “to be under” quarantine. As people move from one category to another, the systems in place track the movements, collate data, and give information.

For instance, the Corona Watch app, using GIS mapping, informs citizens about COVID-19 patients’ whereabouts, cases near the user’s house, and COVID-19–designated government hospitals. The Health Watch app is used by field workers to collect health data from individuals in the containment zone.

• “When a person tests positive, information about his primary and secondary contacts is fed to the contact tracing app, who are then accessed by concerned field teams. They follow up until the contacts are under quarantine.” Currently, contact tracing goes on for up to 72 hours in some cases, while the ideal period is 24 hours.

• Two toll-free helplines, powered by an Interactive Voice Response system and an in-house call center, address people’s COVID-19-related (and also other) grievances.

Box 6: Karnataka, “The Core of COVID-19 Containment Is Contact Tracing”

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• The design should ensure basic features that protect privacy with layers of additional capabilities authorized users may choose to activate.

• Data collected should be made available to public health professionals and researchers in de-identified form to support population-level epidemiological analysis.

• Those who authorize the use of data should continuously and systematically monitor its performance, including its benefits and harms.

• Governments should not enforce mandatory use of digital contact tracing, given the uncertainty about potential benefits and burdens.

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PART VII – TESTING AND TRACING FOR VULNERABLE GROUPS

MIGRANT LABOR AND FOREIGN RETURNEES India has a large number of migrant laborers; 2011 census estimates suggest nearly 120 million interdistrict and 56 million interstate migrants. In addition, a large number of Indians are working abroad, especially in the Middle and Far East. Many migrants tend to be neglected and marginalized, live in precarious conditions, and face barriers to accessing public health and social services. Further, the COVID-19 pandemic has created broad economic insecurity, especially for low-skilled migrants. Loss of wages is coupled with the fear of contacting infection in crowded slums. Social security, family support, access to the public distribution system, as well as an enhanced rural employment guarantee scheme prompted large numbers of migrants to return to their rural homes, triggering spread of infection. These factors considerably complicated the control of the COVID-19 pandemic in India. Overseas migrant workers residing in overcrowded and poorly ventilated camps in Singapore and in many countries in the Middle East suffered from large-scale outbreaks. Sri Lanka, which is known for its legacy of decades-long investment in health systems and a well-established disease surveillance system successfully contained COVID-19. The country with a population of 21.5 million had only 1,950 cases and 11 deaths as of June 22, 2020. Having a clear game plan helped Sri Lanka to prevent a second surge of COVID-19 due to repatriation of more than 60,000 Sri Lankans who wanted to return home (of an estimated one million migrant workers based overseas). Institutional quarantine was made mandatory and repatriation was synchronized with accommodation available in existing quarantine facilities. According to the GOI’s report to the Supreme Court, 5.7 million migrants returned to their homes by special trains and another 4.1 million by road. Anecdotal information suggests increased COVID-19 cases as migrants returned home; as a result, states that managed to contain the spread of the pandemic are now experiencing new challenges (Table 4). Of the 4,275 samples collected in Bihar from migrants who returned onboard Shramik special trains between May 4 and May 13, 320 (or 7.50 percent) tested positive for COVID-19. This is far above the positivity rate for the state, which was about 2.75 percent during that period. This highlights the increasing risks of pandemic spread to rural areas, where health systems are much weaker.

Table 2: Case Count—The Changing Picture

Key states Samples tested Positive cases Migrants Foreign returnees

Uttar Pradesh 11,425 389 111 0

Tamil Nadu 13,219 1,685 31 5

Rajasthan 11,681 369 60 NA

Kerala 3,813 91 27 53

Andhra Pradesh 15,085 216 69 1

Karnataka 7,036 161 91 24

Punjab 4,544 56 2 4 Source: Indian Express 2020. Note: State Data for last 24 hours updated up to 9 pm on June 9; NA= Not available

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Figure 12: Contribution of Interstate Migration to COVID-19 in Maharashtra

Source: Author’s Summary based on The Indian Express reports during June 2020 Figure 12 highlights the importance of interdistrict movements within the state of Maharashtra. So far, most epicenters among high-burden states are in urban areas. However, district-level data from Maharashtra show that movement of migrants is causing spread of COVID-19 in rural areas. Of 33 districts that reported data on migrants/close positive contacts, 15 had more than 50 percent of cases attributed to reverse migration. We tried to estimate how the current ramped-up laboratory capacity translates into

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number of tests that could be done in a day at state level (Figure 13). The analysis suggests wide variation across states. The main concern is that major labor exporting states Bihar, Jharkhand, Uttar Pradesh, Madhya Pradesh, West Bengal have lower capacity to perform tests/million in a day with the current capacity. There is an urgent need to bridge this gap in testing.

Source: Author’s estimate based on COVID-19 testing laboratories approved by ICMR, as of July 15, 2020 Assam is one of few states in India that astutely handled an influx of migrant workers. A mandatory 14-day quarantine was introduced for everyone, including railway and airline passengers. The state encountered enormous challenges in creating capacity to accommodate the huge influx. However, this strategy helped immensely, as 98 percent of the 3,319 cases detected by June 23, 2020 were from quarantine facilities (Deb 2020). Orissa followed the home quarantine approach for returning migrants. The Ganjam District had 70,000 returnees in home quarantine during April. After noting that 15 persons accommodated in institutional quarantine were infected by COVID-19, the district administration undertook two successive mega health screening programs involving more than 20,000 women self-help group members and volunteers to check for community spread in the district. During the screening process, special teams checked for COVID-19 –related symptoms and home quarantine issues. URBAN RESIDENTS COVID-19 has had a major impact on India’s densely populated urban areas. Nearly half of the total reported cases and deaths due to COVID-19 in India are contributed by seven cities (Table 5). Overcrowding and poor housing limits the benefits of social distancing interventions. While testing infrastructure is relatively better in urban areas—with their large public facilities and private sector presence—the main challenge is with tracing contacts, especially in urban slums, due to weak public health extension capacity.

Table 3: Distribution of Covid-19 Confirmed Cases, Deaths and Recoveries in Seven Indian Cities (as of June 23, 2020)

City Confirmed Deaths Recovered Mumbai 67,635 3,735 34,119 Delhi 66,655 2,909 36,602 Chennai 44,205 674 24,670 Ahmedabad 19,386 1,363 14,394 Kolkata 4,815 339 2,599 Indore 4,427 203 3,278 Bangalore 1,505 73 435 Total (7 cities) 208,628 9,296 116,097 % of Indian cases 47 66 47

Source: Covid-19 statistics data from google search with data sources from Wikipedia, government health ministries, the New York times and other sources.

Figure 13: Distribution of States by Existing Testing Capacity (per Million, July 15, 2020)

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1. Screening of all households by teams of four persons with digital thermometers and pulse

oximeters to identify all persons with influenza-like illness (ILI) and severe acute respiratory infections (SARIs) who will be labeled symptomatic.

2. All identified symptomatics will be subjected to antigen test. 3. All those symptomatic negative for antigen test will be subjected to RT-PCR test. 4. For all confirmed cases (antigen or RT-PCR), all household contacts will be kept in home

quarantine for 14 days and closely monitored for development of symptoms. 5. All those household contacts developing symptoms will be subjected to antigen test. 6. We assume that household contacts that remained asymptomatic would be much less

infectious after 14 days. 7. The symptomatic household contacts who are positive for antigen test will be handled as per

the guidelines for positive cases of COVID-19. 8. The symptomatic household contacts negative for antigen test will be tested with RT-PCR. We

looked at three options for follow-up RT-PCR in this group: a. Testing each antigen test negative symptomatic contact with RTPCR b Pooled testing of antigen test negative symptomatic contact in a pool of 5

Box 7: Universal Screening and Targeted Testing in Containment Zones

One success story of COVID-19 containment is emerging from large slum area of Dharavi in Mumbai. With Dharavi’s population of nearly one million living in a 2.5 square kilometer area, and houses just 10×12 feet, providing shelter to large families of seven to eight members, preventive measures such as social distancing and lockdowns cannot be easily implemented, nor was it possible to test everyone. Instead, municipal authorities focused on rigorous contact tracing, testing, and quarantining of COVID-19 cases as well as cleaning community toilets to maintain hygiene since most slum residents depend on these. To tackle the crisis, the Brihanmumbai Municipal Corporation (BMC):

• Set up teams to reach out door-to-door to almost 700,000 people in Dharavi

• Employed 350 local private practitioners with whom patients had a certain level of comfort and trust

• Ran fever clinics to allow people to get themselves checked

• Checked people’s oxygen saturation levels using simple pulse oximeters; if their levels were below 95 percent, they were taken to quarantine centers, where they were looked after

• Allowed people found to have symptoms the option of being quarantined even without getting tested

• Converted local clubs and schools into quarantine facilities where free food and health checkups were provided throughout the day. Until June more than 8,500 were quarantined in such facilities.

• Some quarantine centers also provided more holistic and innovative care such as aerobics, yoga, and breathing exercises, which kept people active and helped them to relax.

• About 2,000 older people, who are most at risk, were taken to "protective quarantine."

By the beginning of June, there were no deaths in Dharavi. The rise of positive cases in Dharavi is now 1.57 percent a day, while that of Mumbai is about 3.00 percent. The doubling rate in Dharavi is now 44 days while in Mumbai it is 22 days. The doubling time in India for active cases is about 26 to 27 days. While the Dharavi story is not yet over, it represents a big change (Gupta 2020). We estimated costs of universal screening and targeted testing of one million urban population in containment zones complementing ICMR guidelines with innovations in Dharavi (Annex 3) and summarized in Box 7. Depending on different assumptions used, we estimate that for each positive case it would cost between Rs 650 to Rs 810 (US$8.6 to US$10.7).

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Source: Author’s Estimate FRONTLINE WORKERS COVID-19 frontline workers include health care staff, contact tracers, police personnel, volunteers, and administrative staff. In China, an estimated 3,000 health care workers (HCWs) have been infected and at least 22 have died (Bai et al. 2020). A sero-surveillance study of 554 health care workers from University Hospitals Birmingham who were at work and asymptomatic showed 2.39 percent (n = 13/544) point prevalence for SARS-CoV-2 RNA (RT-PCR). However, serum samples available for 516 participants showed an overall sero-conversion in the cohort was 24.4 percent (n = 126/516). Individuals who previously experienced a symptomatic illness consistent with COVID-19 had significantly higher sero-conversion rates. Sero-conversion rates were highest among those working in housekeeping (34.5 percent) and acute medicine (33.3 percent), with lower rates among participants working in intensive care (14.8 percent) and emergency medicine (13.3 percent) (Adrian M Shields et al. 2020). This trend was probably due to use of personal protective equipment (PPE) and other safety precautions in intensive and emergency care. A case-control study by ICMR used its data portal, which contained test results and contact details of 23,898 symptomatic health care workers. Out of the 21,402 records obtained, 1,073 (5 percent) were confirmed to be infected with SARS-Cov-2 (Chatterjee et al. 2020). The highest odds were seen among health care workers who never used PPE (3.72 percent), followed by those doing endotracheal intubation (2.5 percent) and those who worked in ICU with suspected or confirmed COVID-19 cases on ventilator (1.36 percent). Press reports suggest that since March, more than 1,200 doctors and nurses tested positive in major Delhi hospitals. It was argued that if other staff such as lab technicians, nursing orderlies, and sanitation workers are added, this number could surpass 2,0009. Press reports from many states, especially Maharashtra (more than 1,000 health staff and 400 police) tested positive, suggest large numbers of cases among health staff, as well as police and municipal staff who were supporting lockdowns. Recognizing that symptoms of COVID-19 may be mild, there is need for pragmatic policies for health care workers who have respiratory illness. All health care workers must consider themselves at elevated risk of exposure, including those involved in support functions such as housekeeping. They must self-monitor and report even mild symptoms. In light of increased vulnerability of health care workers’ families, psychosocial support and appropriate protocols after returning from work are required, including taking off shoes, removing and washing, clothing, and immediately showering. The models used by Korea to undertake pooled samples for health care workers on a regular basis need to be explored. In addition, serological studies—both cohort and cross-sectional—can help to identify specific tasks/practices that make frontline workers vulnerable and introduce new protocols and policies.

9. Media report from News 18 Channel on June 10, 2020

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PART VIII – WAY FORWARD IMMEDIATE MEASURES Enhance what’s working:

• Strategically optimize testing capacity without affecting ongoing priority disease control programs. Under the ICMR’s leadership, India has made phenomenal progress expanding the laboratory network for COVID-19 diagnosis. States should maximize the use of these laboratory networks, especially in the private sector. India’s achievements in control of important infectious diseases, especially TB, should not be compromised while using shared testing platforms. Complementing RT-PCR with antigen testing in urban containment zones, along with periodic serological surveys, helps with early identification of COVID-19 cases and understanding of prevalence and vulnerable populations to inform targeted containment measures.

• Ensure effective compliance with clarified roles and responsibilities of health staff and others key stakeholders in Surveillance, Testing, Tracing, and Risk Communication (Annex 4).

• Generate demand for testing and tracing. Stigma affects demand and compliance for testing and tracing. Targeted risk communication and the involvement of trusted local functionaries and self-help groups to complement frontline workers remains critical to overcome this stigma. Japan is a good example of effectively using staff from existing health facilities for tracing.

• Sustain partnerships with the private sector to complement diagnostic capacity. Addressing market failures, right pricing, and using existing mechanisms such as PM-JAY can create demand for private sector expansion to underserved states. With the potential shown, India can rapidly become a manufacturing hub for diagnostic kits and reagents. Enabling policies are required for export.

Innovate:

• Introduce active case search in urban containment zones with active transmission. Innovations in Dharavi and Delhi suggest active case search and targeted testing using a combination of RT-PCR and antigen tests in urban areas with high test positivity rates helps in containment. For metropolitan areas where infection has not yet reached peak levels or where containment was effective in reducing number of cases, sewage testing can offer an early warning of COVID-19 spread.

• Promote targeted testing of all returning migrants in rural India. As in Kerala, Assam, and Orissa, focusing on testing and tracking returning migrants should be prioritized by both labor exporting and hosting states. Establishing an electronic database of migrant workers helps in providing a more comprehensive response.

• Explore setting up immunological observatory. Laboratory surveillance can be complemented with sero-surveillance of samples already being collected by blood banks using molecular methods to monitor trends of multiple viral diseases. Following this approach, Kenya has shown that SARS-CoV-2 infection rates are much higher than actual cases being reported.

• Promote data triangulation to inform local decisions. Korea demonstrates the benefits of effectively using micro-data for identifying local clusters. These approaches involve district surveillance teams sharing data with local academic institutions to identify hot spots early on.

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MEDIUM-TERM MEASURES • Provide targeted attention to enhance testing infrastructure in states where

capacities are currently weak. Wide variation among states in public health laboratory capacity needs to be addressed by enhancing GOI investments in laboratory infrastructure. States should complement such initiatives with competent human resources and sustained supply of consumables.

• Promote research to develop new testing methods and innovations to enhance efficiency of available methods. The ICMR needs to sustain the momentum in COVID-19 diagnostics by establishing an innovation hub for validating and taking to scale new diagnostics such as RT-Loop-mediated Isothermal Amplification (RT-LAMP) and Next-Generation Sequencing (NGS) kits. Techniques such as pooled sampling and environmental sampling need to be used more extensively.

• Clarify roles and responsibilities of key institutions responding to future pandemics. It is important to revisit roles and responsibilities of three key institutions—the ICMR, the National Center for Disease Control (NCDC), and the National Disaster Management Agency (NDMA)—involved in India’s pandemic response as required by International Health Regulations. We provide an indicative approach below in Figure 14 below.

Figure14: Framework for Efficient Digital Contact Tracing

Source: Authors depiction of roles and responsibilities

Notes: NDMA = National Disaster Management Agency; IHR = International Health Regulations; NCDC = National Center for Disease Control.

• Create a legal framework for digital contact tracing that ensures efficiency without compromising confidentiality. Benefits of digital contact tracing need to be balanced with privacy concerns. As done by Korea, creating an appropriate legal framework that balances these two priorities will help India to be better prepared.

Research promotion

1. Molecular Research

2. Population-based studies

3. Research on exotic and evolving zoonotic diseases

4. Collaborative research -regional and international

5. External quality assurance for viral laboratories

6. Platform for engaging private sector to build diagnostic capacity test kits, reagents, and new testing approaches

7. Population-based studies

8. Research on exotic and evolving zoonotic diseases

9. Collaborative research—

ICMR

Stewardship for disease surveillance

1. Ensure India’s compliance on IHR

2. One health platform coordination

3. Nation-wide Surveillance capacity building -Field Epidemiology Training

4. Digital technology for tracking diseases

5. Alerts on new and exotic diseases

6. Weekly Epidemiological and outbreak reports

7. Internal quality Assurance- laboratories

8. Pandemic preparedness assessment -Table top exercises

NCDC

NDMA 1. Strengthening legal framework for

pandemic response 2. Support responses-lockdowns/large-

scale evacuations 3. Maintaining stockpile for responding to

pandemics

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ANNEX I: COMPARISON OF DIFFERENT TESTING METHODS FOR SARS-COV-2

Description RT-PCR Closed Molecular

Diagnosis (TrueNat /

CBNAAT)

Antigen test Antibody test

How does it work Directly detects the presence of the virus, indicating active infection

Directly detects the presence of the virus, indicating active infection

Directly detects the presence of the virus, indicating active infection

Detects the body’s immune response to the virus, in the form of antibodies (IgG / IgM), which are produced during active infection, but persist after the virus is no longer detected, indicating previous infection

Diagnosis of active infection

Yes Yes Yes No

Sample type Nasopharyngeal, nasal, or oropharyngeal swab

Nasopharyngeal, nasal, or oropharyngeal swab

Nasopharyngeal, nasal, or oropharyngeal swab

Finger stick blood/venous blood

Duration of test 8 hours 2 hours 30 min–1 hour 30 min–1 hour Who can perform Trained lab

Technicians Trained lab Technicians

Trained lab technicians

Trained lab technicians

Training required Extensive technical training

Training for operating samples and processing

Minimal for RDT Minimal for RDT, training required if ELISA method

Sample processing

Highly infectious Moderately infectious

Moderately Infectious

Less infectious

PPE required Yes Yes Yes Yes BSL2/3 required Yes Yes Yes No Uses Triage of suspect cases

Yes Yes Yes No/Depends on performance

Monitor disease progression

Yes Yes Depending on performance

No

Screening of contacts

May be impractical

May be feasible Yes No

Screen contacts for exposure to disease

No No No Yes

Population surveillance

No No No Yes

Source: www.finddx.org/wp-content/uploads/2020/05/FIND_COVID-19_RDTs_18.05.2020.pdf https://en.wikipedia.org/wiki/COVID-19_testing. Notes: RDT = Rapid diagnostic test; ELISA = Enzyme Linked Immunosorbent Assay; PPE = Personal protective equipment; BSL = Biosafety level.

ANNEX II: PRELIMINARY UNIT COST ESTIMATES OF ICMR-APPROVED COVID-19 DIAGNOSTIC TESTS

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Purpose: Prepare preliminary unit cost estimates of Real Time Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) test and molecular methods (TrueNat and GeneXpert) of tests approved by the Indian Council of Medical Research (ICMR) for screening COVID-19 infected persons. Limitations: These estimates are based on information shared by laboratories in charge and assumptions were based on anecdotal data. The estimates for RT-PCR are based on one manufacturer’s data (cost of equipment and output), and these can vary if another make is used. We also assumed that this equipment is exclusively used for COVID-19 testing, which is not the case in routine settings, as they will also be used for testing other diseases (HIV, TB, etc.). As more comprehensive information becomes available, these estimates could be improved further. All assumptions are stated explicitly so that relevant changes could be made when more precise data become available. Approach: The approach used takes into consideration both capital and recurring costs for tests. Capital costs: These included costs of equipment, biosafety requirements, initial consumables, infrastructure, and initial training. The total capital cost was then converted to annualized cost, assuming a five-year life cycle for equipment. The annualized cost was again converted to daily capital cost, assuming 300 working days in a year and unit capital cost per each, taking into consideration throughput for each method, as shown below.

• RT-PCR: 140 tests per a six to eight–hour shift; we assumed two shifts in a day, yielding a total output of 280 tests/day. The cost and outputs will vary by type of equipment used.

• TrueNat: Five test runs of four tests in a six to eight–hour shift, yielding an output of 40 tests/day

• GeneXpert: Four test runs of four tests in a six to eight–hour shift, yielding an output of 32 tests/day

Recurring costs: These include cost of kits, sample collection, transport, reagents, lab consumables, biosafety requirements, and technician time. Again, assumptions for each method are made clear, and they can be changed as new information becomes available. For quality assurance, Kerala’s model of three positive and three negative samples twice a month were used. Preliminary Results:

• The startup capital costs are nearly tenfold higher for RT-PCR compared to molecular tests.

• With the assumed throughput, the capital cost per test is estimated at Rs 28.93, Rs 21.07, and Rs 25.17, respectively for RT-PCR, TrueNat, and GeneXpert tests.

• The recurrent costs per test come to Rs 2,828, Rs 2,069, and Rs 3,066, respectively.

• Thus, average cost per test is Rs 2,857, Rs 2,090, and Rs 3,091 (rounded off), respectively, for three methods.

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Quick Takeaway Messages:

• Among the three tests included in the unit cost analysis, TrueNat is cheaper by a third, but like GeneXpert, it can only do a limited number of tests per day. However, being battery operated and not requiring air conditioning, TrueNat can be used effectively in rural primary care settings (including a mobile van), which is critical, especially in districts where migrants are returning.

• Considering the huge initial capital outlay required, private players making new investments in RT-PCR in underserved states should be assured contracts for at least three years.

34

CAPITAL COSTS FOR COVID-19 TESTING Description RT-PCR TrueNat GeneXpert

Cost (Rs) Assumptions Cost (Rs) Assumptions Cost (Rs) Assumptions

Instrument

10,000,000

Abbott machine roughly costs 10 to 12 million but can be negotiated if bulk requirement

800,000

4 tests per run; NA extraction 25 mins and test run 45 mins

1,600,000

4 tests per run can go up to 16 tests—each runs 90 mins

Biosafety (Hood or BSL3)

250,000

Biosafety cabinet—BSL2 cabinet

250,000

BSL2 cabinet recommended—may not need if room with good ventilation and light

250,000

BSL2 cabinet recommended—May not need if room with good ventilation and light

Infrastructure (civil works, wiring, ventilation, etc.)

300,000

Minor civil works and wiring

100,000

AC is not needed

100,000

AC is needed

Others

1,500,000

Ancillary equipment such as freezer, pipette, lab centrifuge, micro centrifuge, etc.

100,000

2 pipettes with aerosol barrier tips (per tip INR- 2)

150,000

2 pipettes with aerosol barrier tips (per tip INR - 2)

Initial training cost

100,000

7 people per lab; cost of 1,000 per participant and training for 2 days

14,000 7 people per lab; cost of 1,000 per participant and training for 2 days

14,000 7 people per lab; cost of 1,000 per participant and training for 2 days

Total 12,150,000 1,264,000 2,114,000 Annualized costs (assuming life of 5 years)

2,430,000

252,800

422,800

Daily costs (assuming 300 working days)

8,100 843 1,409

Capital cost per test

28.93

2 shifts each day with each doing 140 tests with a total of 280 tests/day

21.07

40 tests per day (5 runs per shift = 20 per shift)

25.17

56 tests (7 runs per shift = 28 tests per shift)

35

Source: Author estimations Notes: NA – Nucleic Acid; BSL – Bio Safety level; VTM – Viral ransport Medium; VLM – Viral Lysis Medium; PPE – Personal Protective Equipment; INR – Indian National Rupee

RECURRENT COSTS

Description RT-PCR TrueNat GeneXpert

Cost Rs Assumptions Cost Rs Assumptions Cost Rs Assumptions Test kits 1,000 Per test kit 1,200 Inclusive of consumables

and reagents

2,000 Inclusive of all consumables and reagents

Sample collection 305 470 tests per 24:57 mins run; per day samples of 470, i.e., ~160 tests (20,000/(160*26) = 5 + 300 for VTM/VLM

38 1 staff for 6 hours shift collect sample; @ rate of 20 tests per shift and 520 tests per month

48 For 6 hours shift 4 test runs, i.e., 16 tests; 16*26 days = 416 tests.

Transport 238 Considering 470 samples transported per day as hub-and-spoke within 200Km range = 6 carriers (60,000)+ (26 days*2,000 per day)

575 Considering 80 samples transported per day as hub-and-spoke within 100Km range = 2 carriers (20,000)+ (26 days*1,000 per day)

719 Considering 64 samples transported per day as hub-and-spoke within 100Km range = 2 carriers (20,000)+ (26 days*1,000 per day)

Reagents 500 Rough estimate

Lab consumables 750 Rough estimate + 250 for nasal swabs

PPE (Sample collection and testing)

21 If 3 people for collection and 6 lab technicians and 1 data entry technician and in a day will do 470 tests; 1,000 per PPE and 10 PPE per day

88 If 3 people for collection and 3 lab technicians and 1 data entry technician, in a day will do (24*60/70) = 20 runs = 20*4 =80 tests; 1,000 per PPE and 7 PPE per day

109 If 3 people for collection and 3 lab technicians and 1 data entry technician in a day will do (24*60) / 90 = 16 runs, i.e.,16*4 = 64 tests; 1,000 per PPE and 7 PPE per day

Technician time 22 For each shift 140 tests*26 days = 3,640 tests per month per shift. Rs 20,000 per technician. 3 technicians and 1 data entry person per shift

77 For 6 hours shift 5 test runs, i.e., 20 tests; 20 tests*26 days = 520 tests in a month

96 For 6 hours shift 4 test runs, i.e., 16 tests; 16*26 days = 416 tests

Quality control

77

INR 1,000 per transport of 6 samples to referral lab

77

INR 1,000 per transport of 6 samples to referral lab

77

INR 1,000 per transport of 6 samples to referral lab

Biomedical waste management

4

PPE + other consumables for 470 tests

14

PPE + other consumables for 80 tests

17

PPE + other consumables for 64 tests

Recurrent cost per test

2,828 2,069 3,066

36

ANNEX III: UNIVERSAL SCREENING AND TARGETED TESTING — COSTS AND EFFICIENCY

We tried to estimate the costs of universal screening and targeted testing of one million population in containment zones, complementing ICMR guidelines with innovations being used by states applying active case search. This involves the following:

1. Screening of all households by teams of four with digital thermometers and pulse oximeters to identify all persons with influenza-like illness (ILI) and severe acute respiratory infections (SARIs) who will be labeled symptomatic.

2. All identified symptomatics will be subjected to antigen test. 3. All those symptomatic negative for antigen test will be subjected to RT-PCR test. 4. For all confirmed cases (antigen or RT-PCR), all household contacts will be kept in

home quarantine for 14 days and closely monitored for development of symptoms. 5. All those household contacts developing symptoms will be subjected to antigen

test. 6. Household contacts that remained asymptomatic assumed to be much less

infectious after 14 days. 7. Symptomatic household contacts who are positive for antigen test will be handled

as per the guidelines for positive case of COVID-19 8. Symptomatic household contacts negative for antigen test will be tested with RT-

PCR. We looked at three options for follow-up RT-PCR in this group: a. Testing each antigen test negative symptomatic contact with RT-PCR b. Pooled testing of antigen test negative symptomatic contact in a pool of five c. Pooled testing of antigen test negative symptomatic contacts in a pool of 13

9. We estimate that for each case detected, the unit intervention cost at a prevalence rate of 5 percent would be US$13.1, US$10.4, and US$8.3, respectively for the above three options.

Table 3A: Cost estimates for various testing scenarios

Source: Authors estimations

Preval ence Rate

%

Estima ted

cases

Sympt omatic cases (40%)

High-risk contacts (4 per sympt. case)

Scenario 1: Initial antigen test followed by RT-PCR for each tested negative

Scenario 2: Initial antigen test followed pooled RT-

PCR for negative symptomatic contacts in

pool of 5

Scenario 3: Initial antigen test followed by Pooled

RT-PCR for negative symptomatic contacts in

pool of 13

INR US$ INR US$ INR US$ 1 10,000 4,000 16,000 8,952,000 114,769 7,434,720 95,317 6,243,729 80,048 2 20,000 8,000 32,000 15,904,000 203,897 12,869,440 164,993 10,487,458 134,455 3 30,000 12,000 48,000 22,856,000 293,026 18,304,160 234,669 14,731,188 188,861 4 40,000 16,000 64,000 29,808,000 382,154 23,738,880 304,345 18,974,917 243,268 5 50,000 20,000 80,000 36,760,000 471,282 29,173,600 374,021 23,218,646 297,675

37

ANNEX IV: TESTING AND TRACING – ROLES AND RESPONSIBILITIES AT DIFFERENT LEVELS OF SERVICE DELIVERY

Levels of care Health Department

staff Others Roles

Surveillance Testing Tracing Risk communication *

Community • Accredited social health activists (ASHAs)

• Anganwadi workers (AWWs)

• Village Health Sanitation and Nutrition Committee

• Self-help groups • Elected representatives

of panchayat and municipal local bodies

• Village Volunteers (NCC, NSS, NYKS, Students)

• NGOs and RWA

• Undertake community surveillance to identify symptomatic—severe acute respiratory infection (SARI) or influenza-like illness (ILI)

• Refer symptomatics/ contacts of confirmed cases for testing

• Identify contacts of suspected/confirmed cases,

• Facilitate home isolation/quarantine

• Monitor contacts daily

• Interpersonal communication

Health subcenter (SC) /subcenter-level health & wellness centers (HWCs)

• Community health officer (CHO)

• Multipurpose health workers (MPHWs)—female and male

Same as above • Syndromic Surveillance as per IDSP guidelines

• IDSP reporting—weekly/SOS S forms

• Real time reporting of ILI and SARI cases

• Refer persons with SARI or ILI for testing

• Identify contacts of confirmed cases

• Support home isolation/quarantine and monitor symptoms

• Interpersonal communication

• Group talks • Role-plays

38

Levels of care Health Department staff

Others Roles Surveillance Testing Tracing Risk

communication * Primary health center (PHC)/ PHC-level HWC

• Medical officers • Ayush doctors • Nurses • Lab

technicians

• Private doctors • Nursing homes • Charitable health

facilities • Microbiology

students

• Identify provisional cases

• IDSP reporting— weekly/SOS P forms

• Surveillance of frontline workers and health care workers (HCW)

• Refer provisional cases for testing

• Specimen collection, packaging, and transportation

• Antigen testing (as per state policies)

• Support home-based care

• Monitor effectiveness of contact tracing, undertaking spot check

• Identify symptoms among frontline staff and HCWs

• Interpersonal communication

• Group talks • Video shows

District • Medical officers • Specialists • Nurses • Laboratory

technicians • District surveillance

unit

• Private hospitals • Charitable

hospitals • Medical colleges • Local industry

• Laboratory confirmation

• IDSP reporting Weekly/S, P and L forms

• Data analysis and identification of hot spots

• HCW surveillance

• RT-PCR Testing

• Management of severe cases (ICU and Ventilation)

• Planning and implementing periodic serological surveys

• Feedback to PHC/SC on confirmed cases to enable contact tracing

• Support and oversight for contact tracing

• Facilitate intersectoral coordination for containment

• Interpersonal communication

• Group talks • Video shows • Radio/TV talks

*Individual responsibility; benefits of wearing masks, social distancing and hygiene practices; common symptoms of COVID-19; importance of testing and isolation/quarantine; respecting human values and avoiding stigma; psychosocial support. Source: Authors understanding of roles and responsibilities Notes: IDSP – Integrated Disease Surveillance Project ; ICU – Intensive care Unit;

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REFERENCES

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In this paper, we bring together promising testing and tracing lessons and approaches from India and globally, based on a desk review of various initiatives and analyses of secondary data. Key lessons and findings are that (i) testing and tracing is central to an effective COVID-19 response; (ii) a robust response to an unprecedented pandemic requires creative approaches, such as active case finding, pooled testing, testing environmental samples, triangulation of microdata, effective contact tracing, and partnering with the private sector; (iii) optimizing COVID-19 testing capacity should not negatively impact ongoing disease control programs; (iv) containment of COVID-19 should go hand-in-hand with preparation for future pandemics. We also summarize innovations and bottlenecks to rapidly scale up testing capacities at the state level, including strategies for optimizing the role of the private sector and introducing new technologies to enhance access to testing in rural populations. This paper offers options especially relevant to Indian policy makers, with a focus on sustained health systems strengthening. .

ABOUT THIS SERIES: This series is produced by the Health, Nutrition, and Population Global Practice of the World Bank. The papers in this series aim to provide a vehicle for publishing preliminary results on HNP topics to encourage discussion and debate. The findings, interpretations, and conclusions expressed in this paper are entirely those of the author(s) and should not be attributed in any manner to the World Bank, to its affiliated organizations or to members of its Board of Executive Directors or the countries they represent. Citation and the use of material presented in this series should take into account this provisional character. For free copies of papers in this series please contact the individual author/s whose name appears on the paper. Enquiries about the series and submissions should be made directly to the Editor Martin Lutalo (mlutalo@ worldbank.org) or HNP Advisory Service (askhnp@worldbank.org, tel 202 473-2256). For more information, see also www.worldbank.org/hnppublications.

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