The potential of rapid point-of-care (POC) tests has been subject of doubt due to an eventual risk of production errors. The aim was therefore to evaluate the two separate production lots of a commercial POC lateral flow test, intended for the detection of IgM and IgG against the SARS-CoV-2 spike protein (S1). Control samples consisted of serum from individuals with confirmed SARS-CoV-2 infection and pre-COVID-19 negative sera gathered from a biobank. The presence of anti-S1 IgM/IgG in the sera was verified by an in-house Luminex-based serological assay (COVID-19 SIA). One hundred samples were verified as positive for anti-S1 IgG and 74 for anti-S1 IgM. Two hundred samples were verified as negative for anti-S1 IgM/IgG. For the two lots of the POC-test, the sensitivities were 93.2% and 87.8% for IgM and 93.0% and 100% for IgG. The specificities were 100% for IgM and 99.5% for IgG. The positive predictive value was 100% for IgM and 98.9% and 99.0% for IgG. The negative predictive value was 97.6% and 95.7% for IgM, and 96.6% and 100% for IgG. The evaluated POC-test is suitable to assess anti-SARS-CoV-2 S1 IgM and IgG, as a measure of previous virus exposure on an individual level. The external validation of separate lots of rapid POC-tests is encouraged to ensure high sensitivity before market introduction.
【저자키워드】 SARS-CoV-2, lateral flow, specificity, S1, POC-test, lot, IgM/IgG, 【초록키워드】 COVID-19, IgG, IgM, SARS-COV-2 infection, POC, risk, virus, anti-SARS-CoV-2, Spike protein, Predictive value, point-of-care, serum, sensitivity, Biobank, Positive predictive value, Serological assay, Lateral flow test, sera, SARS-CoV-2 spike protein, Control, Anti-S1, Negative predictive value, external validation, IgM and IgG, house, subject, individual, measure, doubt, sensitivities, positive, Specificities, anti-S1 IgM, individual level, evaluate, evaluated, the SARS-CoV-2, 【제목키워드】 Production, Test, Rapid, identification, Flow, IgM and IgG, the Spike, Lateral, Part,