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. 2022 Aug 31;37(1):431.
doi: 10.4102/sajid.v37i1.431. eCollection 2022.

Validation of the COVID-19 IgG/IgM Rapid Test Cassette (BNCP - 402 and BNCP402) in a South African setting

Gilad Mensky  1   2 , Tristan Pillay  2   3 , Alexander von Klemperer  2   4 , Merika J Tsitsi  2   5 , Michelle Venter  2   5 , Colin N Menezes  2   5 , Sarah A van Blydenstein  2   6
Affiliations

Validation of the COVID-19 IgG/IgM Rapid Test Cassette (BNCP - 402 and BNCP402) in a South African setting

Gilad Mensky et al. S Afr J Infect Dis. .

Abstract

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.

Keywords: COVID-19; South Africa; antibody test; immunoassay; point of care; rapid testing; sensitivity; serological test.

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Figures

FIGURE 1
FIGURE 1
Common presenting complaints of patients under investigation of COVID-19.
FIGURE 2
FIGURE 2
IgG/IgM Rapid Test Cassette (BNCP–402 and BNCP402) – Comparing the sensitivities of (a) IgM, (b) IgG and (c) combined and how they changed with time.
FIGURE 3
FIGURE 3
IgG/IgM Rapid Test Cassette (BNCP–402 and BNCP402) – Comparing the specificities of (a) IgM, (b) IgG and (c) combined and how they changed with time.
See this image and copyright information in PMC

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References

    1. Zhu N, Zhang D, Wang W, et al. . A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med. 2020;382(8):727–733. 10.1056/NEJMoa2001017 - DOI - PMC - PubMed
    1. Huang C, Wang YLi, X, et al. . Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395(10223):497–506. 10.1016/S0140-6736(20)30183-5 - DOI - PMC - PubMed
    1. Xu X, Yu C, Qu J, et al. . Imaging and clinical features of patients with 2019 novel coronavirus SARS-CoV-2. Eur J Nucl Med Mol Imaging. 2020;47(5):1275–1280. 10.1007/s00259-020-04735-9 - DOI - PMC - PubMed
    1. South African Department of Health . Minister Zweli Mkhize reports first case of Coronavirus Covid-19 [homepage on the Internet]. 2020. [cited 2020 Mar 5]. Available from: https://www.gov.za/speeches/health-reports-first-case-covid-19-coronavir...
    1. Viana R, Moyo S, Amoako DG, et al. . Rapid epidemic expansion of the SARS-CoV-2 Omicron variant in southern Africa. Nature. 2022;603(7902):679–686. 10.1038/s41586-022-04411-y - DOI - PMC - PubMed

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