Evaluation of a SARS-CoV-2 lateral flow assay using the plaque reduction neutralization test.
Diagn Microbiol Infect Dis
; 99(2): 115248, 2021 Feb.
Article
in English
| MEDLINE | ID: covidwho-866639
ABSTRACT
As new tests and technologies advance our understanding and diagnostic capabilities of the severe acute respiratory syndrome coronavirus 2 and the coronavirus disease 2019, they must be appropriately validated to make sure test performance is following manufacturer claims. In this study, we evaluated the Vazyme 2019-nCoV IgG/IgM Detection Kit, which is a lateral flow assay (LFA), by the plaque reduction neutralization test (PRNT) using 100 patient plasma/serum samples. As compared to the PRNT results, the Vazyme LFA had 95.9% sensitivity and 96.1% specificity. Along with the increased need for rapid, effective, and affordable point of care tests to help provide meaningful epidemiological data, we demonstrated that the Vazyme LFA performed well on IgG detection but cannot be judged on the performance of IgM detection using PRNT alone. However, our observation of the low IgM-positive rate supported the poor performance of IgM detection of this LFA which led to the disapproval of its Emergency Use Authorization recently.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Viral Plaque Assay
/
Neutralization Tests
/
SARS-CoV-2
/
COVID-19
/
Antibodies, Viral
Type of study:
Diagnostic study
/
Experimental Studies
/
Observational study
/
Prognostic study
Limits:
Humans
Language:
English
Journal:
Diagn Microbiol Infect Dis
Year:
2021
Document Type:
Article
Affiliation country:
J.diagmicrobio.2020.115248
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