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

Abstract

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-2RNA 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.

A systematic review and meta-analysis comparing the diagnostic accuracy tests of COVID-19

“…Sensitivity and specificity are reported as a mean (95% confidence limits). The forest plot represents the estimated sensitivity and specificity (black squares) and their 95% confidence limits (horizontal black line) [44][45][46][47][48][49][50][51][52][53][54][55][56][57][58]. Sensitivity and specificity are reported as a mean (95% confidence limits).…”

“…Reverse transcription-polymerase chain reaction Fifteen studies based on the RT-PCR technique were selected [44][45][46][47][48][49][50][51][52][53][54][55][56][57][58], in which a total of 6,902 subjects were studied. Sensitivity ranged from 36.8% to 99.2%, with a median of 94.5%, 95%CI (85.1, 98.0), while the test for equality of sensitivities presented a χ 2 = 577.02, df = 38, p-value = 2e -16 .…”

Deploying a Rapid Point-Of-Care Polymerase Chain Reaction Test for Sars-Cov-2 in a Clinical Research Unit to Ensure Healthy Volunteer Safety

“…The assay measures 3 genes. The first is a nucleocapsid N-encoding gene, the second is a conserved sequence from SARS-like viruses and the third gene is a non-virus related human β-globin gene to monitor the cellular content as a surrogate marker of the specimen quality [ 5 ]. The assay was used according to the manufacturer’s instructions with daily checks for each instrument.…”

A retrospective cohort study of the effect of SARS-CoV-2 point of care rapid RT-PCR at the Emergency Department on targeted admission

“…The total analysis time is about 20 min. Sample preparation does not require specialized laboratory setting and the reported sensitivity and specificity for SARS-CoV-2 is 99.3% and 94.7%, respectively [ 7 , 8 ]. This should be compared to the RAD Clinitest Rapid COVID-19 Antigen Test (Siemens Healthineers, Erlangen, Germany) that had a reported sensitivity of 86.5% and a specificity of 99.3% when the Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA).…”