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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.
For a rapid diagnostic anywhere…www.ngbiotech.com