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. 2021 Aug:294:114178.
doi: 10.1016/j.jviromet.2021.114178. Epub 2021 May 4.

Performance evaluation of the Simtomax® CoronaCheck rapid diagnostic test

P J Ducrest  1 , A Freymond  2 , J-M Segura  3
Affiliations

Performance evaluation of the Simtomax® CoronaCheck rapid diagnostic test

P J Ducrest et al. J Virol Methods. 2021 Aug.

Abstract

The aim of this study was to evaluate the diagnostic performance of Simtomax® CoronaCheck, a serology rapid diagnostic test (RDT) for the detection of IgG and IgM against SARS-CoV-2. 48 plasma samples positive for SARS-CoV-2 based on RT-PCR and 98 negative control samples were studied. Diagnostic performance of the IgG/IgM RDT was assessed against RT-PCR and the electro-chemiluminescence immunoassay (ECLIA) Elecsys® Anti-SARS-CoV-2 total Ig. Overall, the RDT sensitivity was 92 % (95 % confidence interval [95 %CI]: 79-97), specificity 97 % (95 % CI: 91-99 %), PPV 94 % (95 % CI: 81-98) and the NPV 96 % (95 % CI: 89-99). When considering only samples collected ≥ 15 days post-symptoms (DPS), the sensitivity increased to 98 % (95 %CI: 86-100) and the specificity was 97 % (95 % CI: 91-99 %). Two samples with 180 DPS were still positive for IgG. Globally, this IgG/IgM RDT displayed a high diagnostic accuracy for SARS-CoV-2 IgG/IgM detection in plasma samples in high COVID-19 prevalence settings. It could be effectively used, in absence of facilities for routine diagnostic serology, for samples with a DPS between 15 and 180 days.

Keywords: COVID-19; Lateral flow immunoassay; Rapid test; SARS-CoV-2; Serology.

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Conflict of interest statement

Percevent J Ducrest has a R&D mandate with Augurix SA, the manufacturer of the RDT used in this study. Augurix SA had no role in the study design, the realization nor in result interpretation. The other authors have no conflict of interest to disclose.

Figures

Fig. 1
Fig. 1
Description of the plasma samples used in this study.
See this image and copyright information in PMC

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