Premium
Performances of the VitaPCR™ SARS‐CoV‐2 Assay during the second wave of the COVID‐19 epidemic in France
Author(s) -
Fitoussi Frédéric,
Dupont Raphaël,
TonenWolyec Serge,
Bélec Laurent
Publication year - 2021
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/jmv.26950
Subject(s) - concordance , virology , covid-19 , medicine , point of care testing , point of care , usability , nucleic acid test , immunology , infectious disease (medical specialty) , disease , pathology , computer science , human–computer interaction
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.