Article ; Online: Evaluation of Production Lots of a Rapid Point-of-Care Lateral Flow Serological Test Intended for Identification of IgM and IgG against the N-Terminal Part of the Spike Protein (S1) of SARS-CoV-2.
2021 Volume 13, Issue 6
Abstract: 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 ... ...
Abstract | 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. |
---|---|
MeSH term(s) | Antibodies, Viral/blood ; Antibodies, Viral/immunology ; COVID-19/diagnosis ; COVID-19/immunology ; COVID-19 Serological Testing/methods ; Humans ; Immunoglobulin G/blood ; Immunoglobulin G/immunology ; Immunoglobulin M/blood ; Immunoglobulin M/immunology ; Point-of-Care Testing ; Sensitivity and Specificity ; Spike Glycoprotein, Coronavirus/immunology |
Chemical Substances | Antibodies, Viral ; Immunoglobulin G ; Immunoglobulin M ; Spike Glycoprotein, Coronavirus ; spike glycoprotein, SARS-CoV |
Language | English |
Publishing date | 2021-05-31 |
Publishing country | Switzerland |
Document type | Evaluation Study ; Journal Article ; Research Support, Non-U.S. Gov't |
ZDB-ID | 2516098-9 |
ISSN | 1999-4915 ; 1999-4915 |
ISSN (online) | 1999-4915 |
ISSN | 1999-4915 |
DOI | 10.3390/v13061043 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
More links
Kategorien
Order via subito
This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.