Performances of the VitaPCR™ SARS‐CoV‐2 Assay during the second wave of the COVID‐19 epidemic in France

Fitoussi, Frédéric; Dupont, Raphaël; Tonen‐Wolyec, Serge; Bélec, Laurent

To assess the practicability (usability and satisfaction) and analytical performances of the VitaPCR™ SARS‐CoV‐2 Assay (Credo Diagnostics Biomedical Pte. Ltd.), a rapid point‐of‐care nucleic acid amplification test (NAAT), by reference to real‐time reverse‐transcription polymerase chain reaction (rRT‐PCR) for respiratory viruses. The practicability of the VitaPCR™ Assay and Instrument was assessed from usability evaluation and a satisfaction questionnaire. Nasopharyngeal swabs were collected from 239 patients with coronavirus disease 2019 (COVID‐19)‐like illness during the second epidemic wave, in Paris, France. Overall, the usability of the VitaPCR™ Instrument was high. The satisfaction questionnaire indicated a high appreciation of the VitaPCR™ NAAT mainly for the short duration of analysis in only 20 min. A total of 140 and 99 samples were positive and negative for SARS‐CoV‐2 RNA by rRT‐PCR, respectively. In the event of significant viral load (i.e., N gene C (t) values 33), the platform's analytical performances dropped significantly, with lower sensitivity, concordance, and accuracy, while its specificity remained high. The VitaPCR™ SARS‐CoV‐2 Assay is an accurate rapid point‐of‐care NAAT, suitable for clinical practice for the rapid diagnosis of COVID‐19, especially in patients with COVID‐19‐suspected symptoms.