Evaluation of Abbott ID-NOW Rapid Assay with Real-Time Reverse Transcription PCR Assay for Detection of SARS-CoV-2

Abstract

Rapid nucleic acid assays have been approved by FDA for managing the COVID-19 pandemic, however its analytical efficiency has not been thoroughly validated. This study evaluates the detection and identification of COVID-19 virus using Abbott ID-Now to rapidly identify cases and intervention practices in comparison to nucleic acid detection. Nasopharyngeal Swabs collected from 611 participants were tested for Abbott ID-NOW and LabGun COVID-19 ExoFast RT-PCR Kit as per manufacturer’s protocol. The results from the ID NOW™ COVID-19 assay were evaluated by comparing results with the standard RT-PCR, which served as a standard reference. The infection burden of SARS-CoV-2 in the population of UAE was 11.62%. Compared to detection using real time-based platforms, the sensitivity, specificity, positive and negative predictive values of the ID-Now were 84.51%, 99.81%, 98.36% and 98.00% respectively for COVID-19. A stratified analysis was also carried out using cycle threshold (Ct) values categorizing as Ct>33 as with low viral loads while those with Ct<33 as high. This demonstrated statistically significant (P<0.0001) decrease in sensitivity in samples (97.87% in low Ct value samples versus 58.33% in high Ct value samples). Even though the sensitivity for Abbott ID NOW™ in this study was lower, the specificity, positive predictive values and negative predictive values were significant in low viral load samples. It is easy to use and interpret, giving early information to support clinical decision-making ID-NOW could be possibly used as a point-of-care test after evaluation in epidemic and endemic settings.