Evaluation of sample pooling for SARS-CoV-2 RNA detection in nasopharyngeal swabs and salivas on the Roche Cobas 6800.

ABSTRACT

The Roche Cobas SARS-CoV-2 test recently received an Emergency Use Authorization from the U.S. Food and Drug Administration UA for pooling of up to six nasopharyngeal swab samples (NPS). We evaluated the 6-pool approach on both NPS and saliva samples using 564 samples (20 positive NPS and saliva samples each and 262 negative NPS and saliva samples each). The sensitivity of the Roche SARS-CoV-2 RNA test for pooled NPS samples was 100 % (95 %CI 83.2-100 %) and the sensitivity for pooled saliva samples was 90 % (95 % CI 68.3-98.8 %). Given the high throughput of the Roche Cobas 6800, pooling of 6 samples has the potential to significantly increase testing capacity without significant loss in sensitivity.