Something about NG Biotech finally. I am expecting a big, positive drum roll for NG Biotech AB tests based on below.
https://www.medrxiv.org/content/10.1101/2020.09.10.20192260v1.full.pdf
Evaluating ten commercially-available SARS-CoV-2 rapid 2 serological tests using the STARD (Standards for 3 Reporting of Diagnostic Accuracy Studies) method
- this is a pre-print version of the study to be published; no diagrams, graphs etc can be seen for the relevant comments
- should be peer reviewed + announced by NG Biotech in next few weeks
- funded by Assistance Publique Hopitaux de Paris (APHP), Medecins Sans Frontieres (MSF) + French Defence Innovation Agency (AID) (which purchased the NG Biotech-AT1 1.3m tests to date)
The 10 RDTs evaluated:
(RDT 1) NG Test IgG-IgM COVID-19 (NG-Biotech, France)
(RDT 2) Anti SARS-CoV-2 rapid test (Autobio Diagnostic, China),
(RDT 3) Novel Coronavirus -2019-nCOVAntibody IgG/IgM (Avioq Bio-tech CO, China),
(RDT 4) NADAL COVID-19 136 IgG/IgM Test (Nal Von Minden, Germany),
(RDT 5) Biosynex COVID-19 BSS (Biosynex, France),
(RDT 6) 2019-nCoV Ab Test (Innovita Biological Technology,China),
(RDT 7) 2019-nCoV IgG/IgM (Biolidics, Singapore),
(RDT 8) COVID-19-CHECK-1 (Veda.Lab, 140 France),
(RDT 9) Finecare SARS-CoV2 Antibody test (Guangzhou Wondfo, China)
(RDT 10) Wondfo SARS-CoV2 Antibody test (Guangzhou Wondfo, China)
Summary:
- study size is believed to be double any comparable study so far, globally
- 250 serum samples from 159 PCR-confirmed patients (collected from 0-32 days after onset of symptoms) in 2 French hospitals
- Only 4 tests achieved ≥98% specificity (RDT 1, RDT 4, RDT 5 and RDT 9)
- Only 3 tests evaluated met French Health Authorities’ thresholds (≥90% sensitivity + ≥98% specificity) (RDT 1, RDT 4, RDT 9)
+
"Among the three RDTs fulfilling the French health authorities’ criteria, only NG-Test 318 IgG-IgM COVID-19 (NG-Biotech) might be considered a self-test since it includes all materials needed for self-puncture and capillary blood recovery"
+
"Namely, that this bedside fingerprick test confirmed infection in <15 minutes and could be performed by a medical practitioner without specialized training or a pathology laboratory"
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- Ann: Atomo and NG Biotech expand COVID-19 partnership
Ann: Atomo and NG Biotech expand COVID-19 partnership, page-104
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