Contribution of VitaPCR SARS-CoV-2 to the emergency diagnosis of COVID-19

Fournier, Pierre-Edouard; Zandotti, Christine; Ninove, Laetitia; Prudent, Elsa; Colson, Philippe; Gazin, Céline; Million, Matthieu; Tissot-Dupont, Hervé; Fenollar, Florence

BACKGROUND: With the persistent COVID-19 pandemic, there is an urgent need to use rapid and reliable diagnostic tools for highly urgent cases. Antigen tests are disappointing with their lack of sensitivity. Among molecular tools allowing a diagnosis in less than an hour, only one, the Cepheid Xpert Xpress SARS-CoV-2 assay, has exhibited a good sensitivity. However, we are also facing a global shortage of reagents and kits. Thus, it is imperative to evaluate other point-of-care molecular tests. METHODS: We evaluated the VitaPCRâ„¢ RT-PCR assay, whose sample analysis time is of approximately 20 min, in nasopharyngeal secretions from 534 patients presenting to our Institute, for the diagnosis of COVID-19, and compared it to our routine RT-PCR assay. We also compared the two assays with tenfold dilutions of a SARS-CoV-2 strain. RESULTS: Compared to our routine RT-PCR and the previous diagnosis of COVID-19, the sensitivity, specificity, positive and negative predictive values of VitaPCRâ„¢ can be evaluated to be 99.3 % (155/156), 94.7 % (358/378), 88.6 % (155/175) and 99.7 % (358/359), respectively. Tenfold dilutions of a SARS-CoV-2 strain show that the VitaPCRâ„¢ was more sensitive that our routine RT-PCR assay. CONCLUSION: The VitaPCRâ„¢ SARS-CoV-2 is an accurate rapid test, suitable for clinical practice that can be performed as part of a point-of-care testing, for the rapid diagnosis of COVID-19.