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Performance evaluation of the Simtomax® CoronaCheck rapid diagnostic test.
Ducrest, P J; Freymond, A; Segura, J-M.
  • Ducrest PJ; GaDia SA, Route de l'ile au bois 1A, 1870 Monthey, Switzerland. Electronic address: percevent.ducrest@gadia.net.
  • Freymond A; Institute of Life Technologies - School of Engineering, HES-SO // University of Applied Sciences Western Switzerland, Sion, Switzerland.
  • Segura JM; Institute of Life Technologies - School of Engineering, HES-SO // University of Applied Sciences Western Switzerland, Sion, Switzerland. Electronic address: jmanuel.segura@hevs.ch.
J Virol Methods ; 294: 114178, 2021 08.
Article in English | MEDLINE | ID: covidwho-1213408
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Reagent Kits, Diagnostic / Immunoassay / COVID-19 Serological Testing / COVID-19 / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Observational study Limits: Adolescent / Adult / Female / Humans / Male / Middle aged / Young adult Language: English Journal: J Virol Methods Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Reagent Kits, Diagnostic / Immunoassay / COVID-19 Serological Testing / COVID-19 / Antibodies, Viral Type of study: Diagnostic study / Experimental Studies / Observational study Limits: Adolescent / Adult / Female / Humans / Male / Middle aged / Young adult Language: English Journal: J Virol Methods Year: 2021 Document Type: Article