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: 97.1, 99.1). The PPA improved with lower cycle threshold (Ct) values: 94.7% (95% CI: 91.2, 97.2) for Ct ≤36, 97.6% (95% CI: 94.5, 99.2) for Ct ≤33, and 99.4% (95% CI: 96.8, 100.0) for Ct ≤30. Discordant results were observed among the three reference rRT-PCR tests across evaluable subjects with suspected COVID-19 infection. For 1,630 cases of symptomatic and asymptomatic subjects suspected of COVID-19, where all three rRT-PCR methods were evaluable, CDC test results differed the most, with 144 discordant results with Roche and 119 with Panther rRT-PCR tests. Roche and Panther test results differed in 67 cases. In summary, the Abbott ID NOW™ COVID-19 2.0 assay can serve as a valuable diagnostic tool in acute symptomatic subjects in point-of-care settings.IMPORTANCEThe Abbott ID NOWTM COVID-19 2.0 assay is a suitable rapid test for diagnosing COVID-19 in acute symptomatic subjects and can be used in point-of-care settings and low-resource settings. With results reported in 12 minutes or less, Abbott ID NOWTM COVID-19 2.0 facilitates timely diagnosis, enabling linkage to appropriate antiviral medication.