Performance evaluation of the Simtomax® CoronaCheck rapid diagnostic test.

Journal of Virological Methods
Percevent J DucrestJ-M Segura

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.

References

May 1, 2020·Nature Medicine·Quan-Xin LongAi-Long Huang
May 7, 2020·JAMA : the Journal of the American Medical Association·Nandini SethuramanAkihide Ryo
Jul 6, 2020·Clinica Chimica Acta; International Journal of Clinical Chemistry·Chenxi LiBing Gu
Jul 22, 2020·European Journal of Clinical Investigation·Diego O AndreyUNKNOWN Geneva Centre for Emerging Viral Diseases

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