Evaluation of the MP Rapid 2019-NCOV IgM/IgG combo POCT test vs. an established platform-based method.
Evaluation of new methods
laboratory methods
point-of-care testing
Journal
Annals of clinical biochemistry
ISSN: 1758-1001
Titre abrégé: Ann Clin Biochem
Pays: England
ID NLM: 0324055
Informations de publication
Date de publication:
07 2021
07 2021
Historique:
pubmed:
9
2
2021
medline:
13
7
2021
entrez:
8
2
2021
Statut:
ppublish
Résumé
Accurate and rapid testing for SARS-COV-2 antibodies could improve the diagnosis and management of COVID-19. In this study, we aim to evaluate the diagnostic accuracy of a commercially available point-of-care lateral flow kit independently and in comparison to an established platform-based system. Samples from 144 PCR-confirmed COVID-19 cases and 130 pre-pandemic negative controls were tested in parallel by MP Rapid 2019-NCOV IgM/IgG Combo test and Roche Elecsys. Comparison of results based on serum and capillary blood testing was undertaken. Sensitivity at day 15 onwards was 100% for both methods. Between days 1 and 7 post admission, the IgM/IgG Combo test and Roche Elecsys shown sensitivity of 74% (95% In comparison to Roche Elecsys, our data show that the MP Rapid 2019-NCOV IgM/IgG Combo test provides a high-confidence assay system for the detection of previous exposure to SARS-COV-2 infection with advantage of affording near-patient testing.
Sections du résumé
BACKGROUND
Accurate and rapid testing for SARS-COV-2 antibodies could improve the diagnosis and management of COVID-19. In this study, we aim to evaluate the diagnostic accuracy of a commercially available point-of-care lateral flow kit independently and in comparison to an established platform-based system.
METHOD
Samples from 144 PCR-confirmed COVID-19 cases and 130 pre-pandemic negative controls were tested in parallel by MP Rapid 2019-NCOV IgM/IgG Combo test and Roche Elecsys. Comparison of results based on serum and capillary blood testing was undertaken.
RESULTS
Sensitivity at day 15 onwards was 100% for both methods. Between days 1 and 7 post admission, the IgM/IgG Combo test and Roche Elecsys shown sensitivity of 74% (95%
CONCLUSION
In comparison to Roche Elecsys, our data show that the MP Rapid 2019-NCOV IgM/IgG Combo test provides a high-confidence assay system for the detection of previous exposure to SARS-COV-2 infection with advantage of affording near-patient testing.
Identifiants
pubmed: 33554608
doi: 10.1177/0004563221995551
doi:
Substances chimiques
Antibodies, Viral
0
Immunoglobulin G
0
Immunoglobulin M
0
Types de publication
Evaluation Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM