Applications of Clear Dx Whole Genome Sequencing System in SARS-CoV-2 Diagnostics

Abdullah K., Iwen P.C. & Abdalhamid B.

Abstract

The use of whole genome sequencing in clinical microbiology laboratories for diagnostic purposes is expanding. The Clear Dx SARS-CoV-2 assay (Clear Labs, San Carlos, CA) has been approved for Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) for the diagnosis of COVID-19 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In this letter, the authors evaluated the use of the Clear Dx SARS-CoV-2 test for the diagnosis of COVID-19. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of Clear Dx SARS-CoV-2 test were 93.6%, 99.1%, 99.6%, 87.8% and 95.3%, respectively.

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