QIAstat-Dx Respiratory SARS-CoV-2 Panel Testing in Pooled Nasopharyngeal Specimens for COVID-19 Screening in a Low Prevalence Setting

Abstract Background: COVID-19 screening in healthcare facilities plays a key role in the management of the ongoing pandemic. Rapid and reliable detection of the virus ensures early identification of cases and targeted measures to prevent transmission of the virus. QIAstat-Dx Respiratory SARS-CoV-2 Panel (QRSP) is a fully automated rapid multiplex PCR assay for common respiratory pathogens including SARS-CoV-2 that can provide sample to result in 70 minutes. However, these tests are less suitable as screening tests because of their high cost and lower throughput. Objective: In this study, we evaluated the performance of QRSP on pooled nasopharyngeal specimens to reduce the cost and improve the turn-around time (TAT) for reporting negative COVID-19 results in a low prevalence setting. Methods: Nasopharyngeal (NP) specimens were simultaneously tested by pooled QRSP (~10 specimens/pool) approach and by standard RT-qPCR, and the results were compared. TAT of reporting negative results with pooled QRSP tests were compared to that of standard testing.Results: In 208 specimens, QRSP test results with specimen pooling were in 96% agreement (Kappa=0.92; 95%CI= 0.75-1) with standard RT-qPCR. Despite pooling, CT values obtained with QRSP were correlated with that of standard RT-qPCR (Pearson correlation coefficient r=0.8343, p=0.0027). The median TAT for negative COVID-19 results by QRSP pooled approach was 2.8 hours (n=1305) compared to 5.4 hours by standard methods (n=4471).Conclusion: Pooled QRSP testing can be implemented for COVID-19 screening in low prevalence settings providing significant cost savings and improving TAT without affecting test quality.