Instructions for Use3 SARS-CoV-2 Fluorescent PCR Instructions for Use Doc. Rev. 1.0 Intended Use...

SARS-CoV-2 Fluorescent PCR Kit

For Research Use Only (RUO)

Instructions for Use

Catalog Number

BUSGN7101109 32 tests



2

SARS-CoV-2 Fluorescent PCR Instructions for Use

Doc. Rev. 1.0

Content

Intended Use .......................................................................................................... 3

Product Description ............................................................................................... 3

Summary and Explanation .................................................................................... 3

Contents and Storage ............................................................................................. 4

Equipment and Consumables Required ................................................................ 5

Warnings and Precautions ..................................................................................... 6

Workflow ............................................................................................................... 7

Specimen Collection and Preparation ................................................................... 8

Extract RNA with Nucleic Acid Extraction Kit .................................................... 9

Perform RT-PCR ................................................................................................. 11

Analyze the Data ................................................................................................. 12

Results Interpretation .......................................................................................... 13

Assay Limitations ................................................................................................ 14

Conditions of Authorization for the Laboratory ................................................. 14

Performance Characteristics ................................................................................ 16

Limit of Detection (LoD) ............................................................................ 16

Inclusivity .................................................................................................... 16

Cross-reactivity ........................................................................................... 16

Interference Substances Studies .................................................................. 19

Clinical Evaluation ...................................................................................... 19

Disposal ............................................................................................................... 20

Manufacturer and Distributors ............................................................................ 21

3


Doc. Rev. 1.0

Intended Use

SARS-CoV-2 Fluorescent PCR Kit is a real-time RT-PCR test intended for the qualitative

detection of nucleic acid from the SARS-CoV-2 in oropharyngeal swab and sputum specimens

from individuals with signs and symptoms of infection who meet CDC criteria for SARS-CoV-

2 testing.

Testing is limited to qualified laboratories designated by CDC and, in the United States,

certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.

§ 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories

The SARS-CoV-2 RNA is generally detectable in oropharyngeal swabs and sputa during the

acute phase of infection. Positive results are indicative of presence of SARS-CoV-2 RNA,

clinical correlation with patient history, clinical observations and other diagnostic information

is needed to determine patient infection status. Laboratories within the United States and its

territories are required to report all positive results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis

for patient management decisions. Negative results must be combined with clinical

observations, patient history, and epidemiological information.

The SARS-CoV-2 Fluorescent PCR Kit is intended for use by experimental operators who have

received professional training in genetic amplification or molecular biological method testing,

and have relevant experimental operation qualifications. The SARS-CoV-2 Fluorescent PCR

Kit is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Product Description

The SARS-CoV-2 Fluorescent PCR Kit contains 3 primer/probe sets which designed to detect

RNA from the SARS-CoV-2 in oropharyngeal swabs and sputa from patients with signs and

symptoms of infection who are suspected of COVID-19, the 3 primer/probe sets target ORF1ab,

N and E gene, respectively.

Summary and Explanation

A cluster of unknown pneumonia cases was reported in Wuhan City, Hubei Province, People’s

Republic of China in late December 2019, which later became a pandemic outbreak known as

coronavirus disease 2019 (COVID-19). Severe acute respiratory syndrome coronavirus 2

(SARS-CoV-2), previously known by the provisional name 2019-nCoV, is the cause of COVID-

4


Doc. Rev. 1.0

19. SARS-CoV-2 is a positive-sense single-stranded RNA virus, belonging to genus

Betacoronavirus. Patients infected with the SARS-CoV-2 may be asymptomatic or develop

symptoms such as fever, cough, fatigue, sputum production, shortness of breath, or muscle pain.

Further development can lead to severe pneumonia, acute respiratory distress syndrome, sepsis,

septic shock, and death.

The SARS-CoV-2 Fluorescent PCR Kit is a molecular in vitro diagnostic test that aids in the

detection and diagnosis SARS-CoV-2 and is based on widely used nucleic acid amplification

technology. The product contains oligonucleotide primers and dual-labeled hydrolysis probes

and control material used in real time RT-PCR for the in vitro qualitative detection of SARS-

CoV-2 RNA in respiratory specimens.

Contents and Storage

Table 1 SARS-CoV-2 Fluorescent PCR Kit

Component Storage 32 Tests 64 Tests 96 Tests

qRT-PCR Reaction Mix -30℃ to -10℃ 544 μL×1 1088 μL×1 816 μL×2

qRT-PCR Enzyme Mix -30℃ to -10℃ 96 μL×1 192 μL×1 288 μL×1

Negative Control -30℃ to -10℃ 450 μL×1 900 μL×1 1350 μL×1

Positive Control -30℃ to -10℃ 450 μL×1 900 μL×1 1350 μL×1

Internal Control -30℃ to -10℃ 64 μL×1 128 μL×1 192 μL×1

Table 2 Nucleic Acid Extraction Kit, Manual Version (Cat. No. GN7102903, 48 tests)

Component Ingredient Storage 48 Tests

Extraction reagent ① Proteinase K 2°C to 8°C 500 μL×1

Extraction reagent ② Lysis Buffer 2°C to 8°C 31 mL×1

Extraction reagent ③ Magnetic nanoparticles 2°C to 8°C 250 μL×1

Extraction reagent ④ Wash Buffer 1 2°C to 8°C 41 mL×1

Extraction reagent ⑤ Wash Buffer 2 2°C to 8°C 36 mL×1

Extraction reagent ⑥ Mineral oil 2°C to 8°C 5 mL×1

Extraction reagent ⑦ Elution Buffer 2°C to 8°C 1.8 mL×1

5


Doc. Rev. 1.0

Table 3 Nucleic Acid Extraction Kit, Fast Version (Cat. No. GN7101909, 32 tests)

Component Ingredient Storage 32 Tests

Extraction reagent

Tris Hydrochloride, Triton X-

100, Sodium hydroxide,

Carrier RNA, DEPC treated

water

-30℃ to -10℃ 1.8 mL×1

Equipment and Consumables Required

Vortex mixer

Microcentrifuge

DynaMag-2 Magnet (Invitrogen, Cat. No. 12321D)

Micropipettes (2 or 10 μL, 200 μL and 1000 μL)

Aerosol barrier pipette tips

Racks for 1.5 mL microcentrifuge tubes

Disposable powder-free gloves and surgical gowns

1.5 mL microcentrifuge tubes (DNase/RNase free)

0.2 mL PCR reaction plates, or 0.2 mL Flat PCR tube 8-cap strips

QIAamp Viral RNA Mini Kit (QIAGEN)

7500 Real-Time PCR Systems with v2.3 software (Applied Biosystems)

6


Doc. Rev. 1.0

Warnings and Precautions

For Research Use Only.

Follow standard precautions. All patient specimens and positive controls should be considered

potentially infectious and handled accordingly.

Do not eat, drink, smoke, apply cosmetics or handle contact lenses in areas where reagents and

human specimens are handled.

Modifications to assay reagents, assay protocol, or instrumentation are not permitted, and are

in violation of the product Emergency Use Authorization.

Handle all specimens as if infectious using safe laboratory procedures. Refer to Interim

Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with

SARS-CoV-2 https://www.cdc.gov/coronavirus/2019-nCoV/lab-biosafety-guidelines.html.

Specimen processing should be performed in accordance with national biological safety

regulations.

Dispose of waste in compliance with the local, state, and federal regulations.

7


Doc. Rev. 1.0

Workflow

The workflow begins with nucleic acids extraction from oropharyngeal swabs which arrive in

the testing site in sample transport/preservation media and sputa. Nucleic acid isolated and

purified using Nucleic Acid Extraction Kit (Maccura), Fast version and Manual version are

provided respectively. For Fast version (only compatible with swab sample), inputting 200μL

sample, 50μL nucleic acid is then eluted, for Manual version, inputting 200μL sample, nucleic

acid is eluted with the volume of 35μL. QIAamp Viral RNA Mini Kit (QIAGEN) is the

alternative for RNA Isolation, 140μL sample input, elution volume is recommended as 80μL.

The purified nucleic acid is reverse transcribed and amplified in One-Step using qRT-PCR

Reaction Mix and qRT-PCR Enzyme Mix, 20μL RNA template is added in qRT-PCR mix, and

the RT-PCR is performed in Applied Biosystems™ 7500 Real-Time PCR instrument. In the

process, the probe anneals to a specific target sequence located between the forward and reverse

primers. During the extension phase of the PCR cycle, the 5’ nuclease activity of Taq

polymerase degrades the probe, causing the reporter dye to separate from the quencher dye,

generating a fluorescent signal. With each cycle, additional reporter dye molecules are cleaved

from their respective probes, increasing the fluorescence intensity. Fluorescence intensity is

monitored at each PCR cycle by Applied Biosystems™ 7500 Real-Time PCR Systems.

Extract RNA from OP or sputum specimens using Nucleic Acid Extraction Kit

Perform RT-PCR using the Applied Biosystems™ 7500 Real-Time PCR Instrument

Analyze data using the Applied Biosystems™ 7500 Real-Time PCR Systems with

v2.3 software

Review results interpretation for patient samples

Prepare qRT-PCR Mix (17 μL qRT-PCR Reaction Mix + 3 μL qRT-PCR Enzyme Mix)

Add sample and control (20 μL RNA template)

8


Doc. Rev. 1.0

Specimen Collection and Preparation

For oropharyngeal swabs

Put the collected oropharyngeal swabs into the disposable virus sampling tube containing virus

preservation solution, discard the tail and tighten lid.

For sputa

Sputum specimen should be liquefied with phosphate buffer which contains 1g/L proteinase K,

then tighten lid and seal with sealing film. The sputum specimen should be sent for test within

30 minutes as far as possible.

Before the test of sputum specimen, incubate the specimen at 55℃ for 15 minutes to inactivate

virus. Add proteinase K after incubation if sputum collection cup not containing proteinase K,

then repeat the incubation step.

General requirements for specimen transport and inactivation

It is recommended to test the specimen as soon as possible. Specimens may be stored for up to

24 hours at 2°C~8°C, otherwise shall be stored at -70°C for longer storage, however, multiple

freeze-thaw cycles of specimens should be avoided.

For inactivating virus, preheat a constant temperature water bath to 56℃ in advance, spray the

sealed package containing the specimen with 75% ethanol in a biosafety cabinet. After wiping

the sealed package with absorbent paper, place the specimen in the water bath for 30min. Cover

the collection tube with heavy objects to prevent it from floating. Gently blend the specimen

per 10min.

9


Doc. Rev. 1.0

Extract RNA with Nucleic Acid Extraction Kit

Before you begin

Take out and equilibrate all extraction reagent components and Internal Control (from SARS-

CoV-2 Fluorescent PCR Kit) at ambient temperature, vortex and transfer to the sample area.

Manual Version (Cat. No. GN7102903)

Sample preparation

This step requires laboratory’s own magnetic separator (DynaMag-2 Magnet (Invitrogen, Cat.

No. 12321D) is recommended).

1. Mark 1.5mL or 2.0mL centrifuge tube and add 10μL of Extraction reagent ① to each tube.

2. Add 200~300μL of specimen to each tube, close the lid, vortex for 5 seconds, and spin down

briefly.

3. Prepare Magnetic beads Mix:

Name Reagent Volume/test Number of tests

Magnetic beads Mix

Extraction reagent ③ 5μL N=n+2

Internal Control 2μL

Note: The number of tests is N = n + 2, where n is the number of samples to be tested, and 2

indicate Negative Control and Positive Control. Based on laboratory conditions, due

consideration shall be given to the losses in the mixture dispensing process.

4. Add 600μL of Extraction reagent ②, 7μL of Magnetic beads Mix to each tube, close the lid,

vortex for 10 seconds, and incubate for 10 minutes at ambient temperature.

5. Spin down briefly and place the tube on the magnetic separator, hold for 3 minutes, then

slowly pipette out and discard the supernatant (avoid touching the brown sediment attached to

the wall of the tube).

6. Add 800µL of Extraction reagent ④ to each tube, close the lid, vortex for 5 seconds, spin

down briefly and place the tube on the magnetic separator, hold for 3 minutes, then slowly

pipette out and discard the supernatant (avoid touching the brown sediments attached to the

wall of the tube).

7. Add 700µL of Extraction reagent ⑤ and 100µL of Extraction reagent ⑥ to each tube,

close the lid, vortex for 5 seconds, spin down briefly and place the tube on the magnetic

separator again.

8. After holding for 3 minutes, two layers of supernatant are obviously visible, insert the pipette

tip to the bottom, slowly pipette out and discard the bottom layer, vortex for 30 seconds and

place the tube on the magnetic separator again.

9. After holding for 3 minutes, pipette out and discard residual supernatant.

10. Add 35µL of Extraction reagent ⑦ to each tube, vortex to resuspend brown sediments

10


Doc. Rev. 1.0

completely in the solution, then incubate at 60℃ for 10 minutes.

11. Spin down briefly, place the tube on the magnetic separator and hold for 3 minutes, the

supernatant can be used for subsequent tests, or transferred to a clean Eppendorf tube and stored

at -20℃ or below.

Fast Version (Cat. No. GN7101909)

Sample preparation (only compatible with oropharyngeal swab)

1. Transfer 200μL of specimen, add 2μL Internal Control to 1.5mL centrifuge tube, centrifuge

at ambient temperature for 10min at 13,000 xg.

2. After centrifugation, remove supernatant by pipetting. (avoid touching the sediment if there

is any).

3. Add 50μL of Extraction Reagent, vortex for 10 seconds, and incubate for 10 minutes at

ambient temperature for later use.

Note: If nucleic acid is extracted with QIAamp Viral RNA Mini Kit (QIAGEN), remember to

add 2μL Internal Control with per sample. Recommended volume of extraction and elution is

as follows:

Extraction reagent Volume of sample Volume of elution buffer

QIAamp Viral RNA Mini Kit 140μL 80μL

11


Doc. Rev. 1.0

Perform RT-PCR

Reagent preparation (in reagent preparation area)

1. Take out and equilibrate all reagent components at ambient temperature, vortex briefly.

2. Prepare qRT-PCR Mix according to the following table:

Name Reagent Volume/test Number of tests

qRT-PCR Mix qRT-PCR Reaction Mix 17μL

N=n+2 qRT-PCR Enzyme Mix 3μL

Note: The number of tests is N = n + 2, where n is the number of samples to be tested, and 2

indicate negative control and positive control. Based on laboratory conditions, due

consideration shall be given to the losses in the mixture dispensing process.

3. Aliquot qRT-PCR Mix (20μL/test) into PCR reaction tube/plate.

Sample preparation (in the sample preparation area)

1. Add 20μL RNA template (nucleic acid extracted from Negative Control, Positive Control

and specimen) to the PCR reaction tube/plate containing qRT-PCR Mix, Final volume should

be 40μL/test.

2. Close the lid or seal the plate immediately to avoid contamination. Spin down briefly and get

ready to perform PCR reaction.

PCR amplification (in the thermal-cycling area)

1. Set up the Applied Biosystems™ 7500 Real-Time PCR Instrument.

Reaction volume: 40μL.

Passive reference: None

Assay is as follows:

IMPORTANT!

• The experiment workflow is recommended to be carried out in segmented PCR

laboratories.

• To prevent contamination, prepare reagents in a PCR workstation or equivalent

amplicon-free area, always use aerosol barrier pipette tips processing samples and

positive controls, and do not reuse the pipette.

• Run the plate / strip within two hours of preparation.

• Include one Positive Control and one Negative Control per run, at least.

12


Doc. Rev. 1.0

Fluorescence channel setting:

Reporter Dye FAM VIC / HEX ROX CY5

Quencher None None None None

Detector ORF1ab Internal Control E gene N gene

Set up the plate layout by assigning a unique sample name to each well.

Set and confirm the thermal-cycling protocol:

Step Temperature Time Cycles

1 Reverse transcription 55℃ 15min 1

2 Taq polymerase activation, pre-denaturing 95℃ 2min 1

3 Denaturation 95℃ 15sec

40 Annealing, extension, fluorescence acquisition 58℃ 35sec

4 Instrument cooling 40℃ 10sec 1

2. Save file, start run.

Analyze the Data

1. Set the Ct Threshold

Please save the result after run is completed at first. Threshold level, Start value and End value

of baseline of different channel could be manually adjusted as follows: Start value sets to 3~15,

end value sets to 5~20. Threshold level should be adjusted according to fluorescence

background and Negative Control (NC): higher than fluorescence background and NC. FAM,

ROX, CY5 amplification curve of NC should be horizontal or lower than Threshold level. Click

“Analyze” and view the results on the Report screen.

13


Doc. Rev. 1.0

2. Quality control

Any experiment should meet the following requirements, otherwise the sample results are

invalid and should be retested.

Control Name FAM VIC / HEX ROX CY5

Positive Control ≤32 ≤38 ≤32 ≤32

Negative Control >38 or no Ct value ≤38 >37 or no Ct value >38 or no Ct value

3. Export data

Select the well containing samples and controls, export file (XLSX) to a folder.

Results Interpretation

Interpretation of Ct value of the target gene

Result of judgement Negative (-) Positive (+)

FAM channel (ORF1ab）＞38 or no Ct value ≤38

ROX channel（E gene）＞37 or no Ct value ≤37

Cy5 channel（N gene）＞38 or no Ct value ≤38

HEX or VIC channel（Internal Control） ≤38 /

Based on the above test results, the sample interpretation is as follows:

Test result Result interpretation

ORF1ab, N gene and E gene are all (+)

SARS-CoV-2 positive ORF1ab (+) and N gene (+)

ORF1ab (+) and E gene (+)

Only ORF1ab gene (+) Repeat the test (on the same sample). If it is still (+), it will be

interpreted as SARS-CoV-2 positive

Only ORF1ab gene (-) Repeat the test. If ORF1ab, and N gene and/or E gene are (+),

interpret the result as SARS-CoV-2 positive; Otherwise

interpret the result as suspect who need to be retested the other

time.

ORF1ab (-) and N gene (+)

ORF1ab (-) and E gene (+)

ORF1ab, N gene and E gene are all (-) SARS-CoV-2 negative

14


Doc. Rev. 1.0

Assay Limitations

• The test result of this product is positive, which can indicate the presence of SARS-CoV-2

in the tested samples. The clinical diagnosis and treatment of patients should be considered

in combination with other symptoms/signs, medical history, other laboratory tests and

treatment responses.

• The results of sample testing are related to the process of sample collection, transfer,

storage and processing, and any mistakes may lead to inaccurate results. If cross-

contamination is not properly controlled during sample processing, false positive results

may occur.

• The test is limited to the specified extraction reagents, specimen types, and applicable

instruments. Other unverified situations require laboratory verification before use.

• During the design of this product, relatively conservative fragments of viral nucleic acids

were selected for amplification and detection, but the virus gene is possible to mutate.

Although the mutation rate in the conservative region which selected for amplification

detection is very small, but the possibility cannot be completely avoided theoretically.

• This product cannot be used for the differential diagnosis of SARS.

• Test results shall be determined according to the “result interpretation”.

Conditions of Authorization for the Laboratory

The SARS-CoV-2 Fluorescent PCR Kit Letter of Authorization, along with the authorized Fact

Sheet for Healthcare Providers, the authorized Fact Sheet for Patients and authorized labeling

are available on the FDA website:

Use of the SARS-CoV-2 Fluorescent PCR Kit must follow the procedures outlined in these

manufacturer’s Instructions for Use and the conditions of authorization outlined in the Letter of

Authorization. Deviations from the procedures outlined are not permitted under the Emergency

Use Authorization (EUA). To assist clinical laboratories running the SARS-CoV-2 Fluorescent

PCR Kit, the relevant Conditions of Authorization are listed verbatim below, and are required

to be met by laboratories performing the EUA test.

Authorized laboratories1 will include with reports of the results of the SARS-CoV-2

Fluorescent PCR Kit, all authorized Fact Sheets. Under exigent circumstances, other

appropriate methods for disseminating these Fact Sheets may be used, which may include mass

media.

Authorized laboratories will perform the SARS-CoV-2 Fluorescent PCR Kit as outlined in the

15


Doc. Rev. 1.0

SARS-CoV-2 Fluorescent PCR Kit Instructions for Use. Deviations from the authorized

procedures, including the authorized RT-PCR instruments, authorized extraction methods,

authorized clinical specimen types, authorized control materials, authorized other ancillary

reagents and authorized materials required to perform the SARS-CoV-2 Fluorescent PCR Kit

are not permitted.

Authorized laboratories will have a process in place for reporting test results to healthcare

providers and relevant public health authorities, as appropriate.

Authorized laboratories will collect information on the performance of the test and report to

DMD/OHT7-OIR/OPEQ/CDRH (via email: [email protected]) and CDC

([email protected]) any suspected occurrence of false positive or false negative results and

significant deviations from the established performance characteristics of the test of which they

become aware.

16


Doc. Rev. 1.0

Performance Characteristics

Limit of Detection (LoD)

LoD studies determine the lowest detectable concentration of SARS-CoV-2 at which

approximately 95% of 20 replicates test positive. The LoD was determined by limiting dilution

studies using contrived samples which prepared by oropharyngeal swab and sputum matrix,

respectively, and spiked with viral genomic RNA at several concentrations and processed

through the SARS-CoV-2 Fluorescent PCR Kit workflow.

Extraction Reagent LoD

Oropharyngeal swab Sputum

Nucleic Acid Extraction Kit (Manual) 1000 copies/mL 1000 copies/mL

Nucleic Acid Extraction Kit (Fast) 1000 copies/mL Not compatible

QIAamp Viral RNA mini Kit 1000 copies/mL 1000 copies/mL

Inclusivity

In silico analysis including NCBI Nucleotide BLAST and MegAlign analysis, typical SARS-

CoV-2 isolate sequences (published on GISAID and NCBI) from different country were chosen

to analyze. Results show ORF1ab primer/probe set is the most specific primer/probe set among

the three, targeting all SARS-CoV-2 strains, but not any other human coronavirus, while N gene

and E gene primer/probe sets not only targeting SARS-CoV-2, but also targeting SARS-CoV

or bat coronavirus.

Thus, ORF1ab + E + N was used in combination to interpret result, and ORF1ab result serves

as the most important and final determination to indicate the presence of SARS-CoV-2 RNA.

N gene and E gene results serve as the measure to prevent false negative result. Thus in silico

inclusivity results were acceptable for this product.

Cross-reactivity

In silico analysis of the following microorganisms:

Microorganism

Alignment between primer/probe and sequence

ORF1ab E gene N gene

Primer Set Probe Primer Set Probe Primer Set Probe

Human coronavirus 229E No PCR product

17


Doc. Rev. 1.0

Microorganism




Human coronavirus HKU1 No PCR product

18


Doc. Rev. 1.0

Microorganism




Respiratory syncytial virus No PCR product

19


Doc. Rev. 1.0

The In silico analysis including Primer-BLAST and probe blastn. Primer-BLAST results

indicate SARS-CoV has potential amplification of ORF1ab, E gene and N gene, while blastn

results indicate the probe of E gene and N gene have 100% identity with SARS-CoV, the probe

of ORF1ab has 88% identity. Given the low prevalence of SARS-CoV, the in silico results are

clinically irrelevant. Other selected organism isolates show no PCR product of ORF1ab, E gene

and N gene, probe blastn results show alignments have

20


Doc. Rev. 1.0

that the comparator assay and the evaluated assay are highly consistent.

In between clinical diagnosis and the evaluated assay, a total number of 537 samples were

statistically analyzed, in which 231 samples were clinically diagnosed as positive for SARS-

CoV-2, while 306 samples were excluded for SARS-CoV-2. As a result, 230 samples are

consistently positive between clinical diagnosis and the evaluated assay, and the positive

coincidence rate is 99.57% [95%CI：97.59%~99.92%], while 306 samples are consistently

negative, and the negative coincidence rate is 100%[95%CI：98.76%~100%]. Total coincidence

rate is 99.81% [95%CI：98.95%~99.97%]. Kappa coefficients is 0.996, which is higher than

0.8, indicating that clinical diagnosis and the evaluated assay are highly consistent.

To summarize, the evaluated assay (Maccura) is equivalent to similar NMPA approved

comparator assays as well as clinical diagnosis. The analytical sensitivity and analytical

specificity of the evaluated assay is sufficient to meet clinical needs.

Disposal

Dispose of hazardous or biologically contaminated materials according to the practices of your

institution.

21


Doc. Rev. 1.0

Manufacturer and Distributors

Manufacturer information

Manufacturer Name: Maccura Biotechnology Co., Ltd.

Address: 16#, Baichuan Road, Hi-tech Zone, 611731 Chengdu, PEOPLE'S REPUBLIC OF CHINA

Post-sale Service Unit: Maccura Biotechnology Co., Ltd.

Tel: +86 28 8782 6777

Fax: +86 28 8782 5783

E-mail: [email protected]

Production Address: 16#, Baichuan Road, Hi-tech Zone, 611731 Chengdu, PEOPLE'S REPUBLIC OF CHINA

Distributor information

Maccura Biotechnology (USA) LLC

11300 Rockville Pike, Suite 715, Rockville, MD 20852

Tel: 240-669-9948

Fax:240-833-3956

Symbols for use in the labeling

Symbols Definition

PROTECT FROM SUNLIGHT

STORAGE TEMPERATURE LIMITATION

IN VITRO DIAGNOSTIC USE

UPWARD

DISPOSE IN TRASH AFTER USE

RECYCLABLE MATERIAL

CONSULT INSTRUCTIONS FOR USE

BATCH CODE

CATALOGUE NUMBER

USE BY

DATE OF MANUFACTURE

MANUFACTURER

SUFFICIENT FOR TESTS

Date post:	30-Jan-2021
Category:	Documents
Upload:	others
View:	6 times
Download:	0 times

Instructions for Use3 SARS-CoV-2 Fluorescent PCR Instructions for Use Doc. Rev. 1.0 Intended Use...

Documents