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 Ct 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.
Keywords: COVID-19; NAAT; PCR; SARS-CoV-2; VitaPCR™; bedside testing; innovative approach; point-of-care; practicability; sensitivity; specificity.
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