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Clinical performance of Abbott ID NOW™ COVID-19 2.0 rapid molecular point-of-care test compared to three real-time RT-PCR assays

ABSTRACT Timely diagnosis of SARS-CoV-2 is important for infection control and treatment. Real-time reverse transcriptase PCR (rRT-PCR) tests are the reference standard for diagnosis but often require a centralized laboratory, making them time-intensive and unsuitable for resource-limited settings. The Abbott ID NOW™ COVID-19 2.0 assay is a rapid point-of-care (POC), isothermal molecular test for qualitative detection of SARS-CoV-2. We prospectively evaluated its clinical performance against three reference rRT-PCR tests: Hologic Panther Fusion, Roche Cobas, and CDC 2019-nCoV RT-PCR Diagnostic Panel. Investigators enrolled 3,530 subjects, with 3,146 evaluable. In symptomatic subjects ( n = 914), the test showed a positive percent agreement (PPA) of 91.7% (95% confidence interval [CI]: 87.8, 94.4) and a negative percent agreement (NPA) of 98.4% (95% CI: …

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