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

Abstract

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 VitaPCR™ 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 VitaPCR™ 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 VitaPCR™ was more sensitive that our routine RT-PCR assay. Conclusion The VitaPCR™ 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.

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

“…Our observations confirm the previous analytical evaluation of the VitaPCR™ platform for SARS-CoV-2 RNA molecular detection by Fournier and colleagues, 16 | 4355 late phase of the infection typically associated with a low viral load.…”

Clinical performance of the Abbott Panbio with nasopharyngeal, throat, and saliva swabs among symptomatic individuals with COVID-19

“…All studies examined paired NP swabs tested with the Panbio and a PCR-based platform, with two of the four studies using the Allplex (Seegene, South Korea) [3,4]. One study [2] used the VitaPCR SARS-CoV-2 (Credo diagnostics, Singapore) that has limited data available on its performance, which may explain why 7 samples were Panbio positive but VitaPCR SARS-CoV-2 negative [10]. Gremmels et al performed testing on the Panbio up to 2 h from collection, which may account for the lower sensitivity detected (72.6%) [3].…”

Real-World Clinical Performance of the Abbott Panbio with Nasopharyngeal, Throat and Saliva Swabs Among Symptomatic Individuals with COVID-19

“…3,4 One study used the VitaPCR SARS-CoV-2 (Credo diagnostics, Singapore) that has limited data available on its performance, which may potentially explain why 7 samples were Panbio positive but VitaPCR SARS-CoV-2 negative. 9 Gremmels et al performed testing on the Panbio up to 2 hours from collection, which may account for the lower sensitivity detected (72.6%). 3 Of the studies that examined positivity rate based on symptom duration, one study found no difference in positivity rate with duration of symptom onset 3 , whereas another found higher sensitivity in individuals with symptom onset < 7 days (sensitivity 86.5%) compared to individuals with symptom onset ≥ 7 days (sensitivity 53.8%).…”

“…3,4 One study 2 used the VitaPCR SARS-CoV-2 (Credo diagnostics, Singapore) that has limited data available on its performance, which may potentially explain why 7 samples were Panbio positive but VitaPCR SARS-CoV-2 negative. 9 Gremmels et al . performed testing on the Panbio up to 2 hours from collection, which may account for the lower sensitivity detected (72.6%).…”