Validation of the COVID-19 IgG/IgM Rapid Test Cassette (BNCP – 402 and BNCP402) in a South African setting
Southern African Journal of Infectious Diseases
| Field | Value | |
| Title | Validation of the COVID-19 IgG/IgM Rapid Test Cassette (BNCP – 402 and BNCP402) in a South African setting | |
| Creator | Mensky, Gilad Pillay, Tristan von Klemperer, Alexander Tsitsi, Merika J. Venter, Michelle Menezes, Colin N. van Blydenstein, Sarah A. | |
| Description | Background: Different diagnostic tools could improve early detection of coronavirus disease 2019 (COVID-19). A number of antibody-based serological point-of-care tests have been developed to supplement real-time reverse transcriptase polymerase chain reaction (RT-PCR)-based diagnosis. This study describes the validity of an antibody test, namely the immunoglobulin G (IgG)/immunoglobulin M (IgM) Rapid Test Cassette® (BNCP – 402 and BNCP402), manufactured by Spring Healthcare Services.Methods: A prospective cohort validation study was undertaken at Chris Hani Baragwanath Academic Hospital between 16 July 2020 and 12 August 2020. A total of 101 patients admitted as COVID-19 cases under investigation were included in the study. They were divided into two categories depending on time since symptom onset: testing performed within seven days (early cohort) and after seven days (late cohort). The rapid antibody test was compared to the RT-PCR.Results: Overall, the test has a sensitivity and specificity of 85.2% and 80.0%, respectively, for a combination of IgG and IgM. Sensitivity and specificity of IgG testing alone were 81.5% and 85%. Sensitivity improved for testing with increasing time from symptom onset; however, specifity was not significantly different.Conclusion: The study data adds to the body of evidence that because of relatively low sensitivity and specificity, there is a limited role for antibody-based point-of-care testing in the acute phase of COVID-19 infection, as was the case with this IgG/IgM Rapid Test Cassette (BNCP – 402 and BNCP402). There may exist a role for such testing in patients recovered from prior COVID-19 infection or in seroprevalence studies; however, additional evaluations at later timepoints from symptom onset are required. | |
| Publisher | AOSIS Publishing | |
| Date | 2022-08-31 | |
| Identifier | 10.4102/sajid.v37i1.431 | |
| Source | Southern African Journal of Infectious Diseases; Vol 37, No 1 (2022); 6 pages 2313-1810 2312-0053 | |
| Language | eng | |
| Relation |
The following web links (URLs) may trigger a file download or direct you to an alternative webpage to gain access to a publication file format of the published article:
https://sajid.co.za/index.php/sajid/article/view/431/1035
https://sajid.co.za/index.php/sajid/article/view/431/1036
https://sajid.co.za/index.php/sajid/article/view/431/1037
https://sajid.co.za/index.php/sajid/article/view/431/1039
https://sajid.co.za/index.php/sajid/article/view/431/1038
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