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Multiple studies · IgG-IgM COVID-19 rapid serological tests enable reliable estimates of...

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Page 1: Multiple studies · IgG-IgM COVID-19 rapid serological tests enable reliable estimates of SARS-CoV-2 prevalence offering valuable insights for epidemiological studies, while they
Page 2: Multiple studies · IgG-IgM COVID-19 rapid serological tests enable reliable estimates of SARS-CoV-2 prevalence offering valuable insights for epidemiological studies, while they
Page 3: Multiple studies · IgG-IgM COVID-19 rapid serological tests enable reliable estimates of SARS-CoV-2 prevalence offering valuable insights for epidemiological studies, while they

For a rapid diagnostic anywhere…

AP-HP*: group of Parisian public Hospitals and Medical centres.

Multiple studies

Study Location Type of study Number of

samplesType of samples

SENSITIVITY> 15 days ofsymptoms

SPECIFICITY Objectives Publication

AP-HP* PERFORMANCEEVALUATION 107 Sera 100% 100% CE marking

(PRO) Data on the IFU

AP- HP* PERFORMANCEEVALUATION 306 Sera 97% 100% publication

Dortet, L. et Al., Rapid Determination of SARS-CoV-2 Antibodies Using a Bedside, Point-of-Care, Serological Test. The Lancet (2020) (4/20/2020). DOI: http://dx.doi.org/10.2139/ssrn.3582814

AP-HP*

PERFORMANCEEVALUATION

+ COMPETITORS (10 LFIA and 3

ELISA)

504 Sera 95,30% 100% publication Submitted – publication in progress

AP-HP* CLINICAL CASES N-A Sera N-A N-A publication Submitted – publication in progressAP-HP and a Parisian

Private Hospital

PERFORMANCEEVALUATION 92 Capillary

whole blood 100% 100% publication Submitted Emergency Medicine Journal –publication in progress

CHU Angers (university hospital– Angers - France)

PERFORMANCEEVALUATION

+ COMPETITORS (2 ELISA and 1 LFIA)

293 Sera 100% 95,3% publication

Nicole,T. et Al., Assessment of SARS-CoV-2 serological tests for the diagnosis of COVID-19 through the evaluation of three immunoassays: two automated immunoassays (Euroimmunand Abbott) and one rapid lateral flow immunoassay (NG Biotech), Journal of Clinical Virology (2020), DOI: https://doi.org/10,1016/j.jcv.2020.104511

NG-Test® IgG-IgM COVID-19 rapid serological tests enable reliable estimates of SARS-CoV-2 prevalence offering valuable insights for epidemiological studies, while they are useful for the evaluation of asymptomatic individuals, symptomatic patient with suggestive clinical or imaging signs with negative RT-PCR (or if RT-PCR is not possible before day7 post-symptoms) or for any a posteriori diagnosis.

Page 4: Multiple studies · IgG-IgM COVID-19 rapid serological tests enable reliable estimates of SARS-CoV-2 prevalence offering valuable insights for epidemiological studies, while they

For a rapid diagnostic anywhere…www.ngbiotech.com


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