Dataset Information

Abbott ID NOW™ COVID-19 assay: do not discard the swab.

ABSTRACT: We compared the performance of ID NOW™ COVID-19 assay nasal swabs with RT-PCR of nasopharyngeal swabs for SARS-CoV-2 in an outbreak setting, determining whether addition of RT-PCR of residual nasal swabs (rNS) (post ID NOW™ elution) would increase overall analytic sensitivity. Devices were placed at 2 long term and 1 acute care sites and 51 participants were recruited. Prospective paired nasopharyngeal and nasal samples were collected for RT-PCR and ID NOW™. ID NOW™ had a positive and negative categorical agreement of 86% and 93% compared to RT-PCR of nasopharyngeal swabs. Sensitivity and specificity of the ID NOW™ was 86% and 100%, positive and negative predictive value was 100% and 95% (COVID-19 positivity rate: 8%). Addition of rNS RT-PCR increased the positive and negative categorical agreement to 93% and 97%. Based on these results, we propose an alternative workflow which includes complementary testing of rNS on a secondary assay.

SUBMITTER: MacDonald C

PROVIDER: S-EPMC9556880 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Abbott ID NOW™ COVID-19 assay: do not discard the swab.

MacDonald Clayton C Desruisseaux Claudine C Eckbo Eric E Li Lisa L Locher Kerstin K Wong Titus T Grant Jennifer J Lavergne Valery V Schaeffer David F DF Hoang Linda M N LMN Charles Marthe M

Diagnostic microbiology and infectious disease 20221013 4

We compared the performance of ID NOW™ COVID-19 assay nasal swabs with RT-PCR of nasopharyngeal swabs for SARS-CoV-2 in an outbreak setting, determining whether addition of RT-PCR of residual nasal swabs (rNS) (post ID NOW™ elution) would increase overall analytic sensitivity. Devices were placed at 2 long term and 1 acute care sites and 51 participants were recruited. Prospective paired nasopharyngeal and nasal samples were collected for RT-PCR and ID NOW™. ID NOW™ had a positive and negative ...[more]

PMID: 36731196

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Project description: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.

Dataset Information

Abbott ID NOW™ COVID-19 assay: do not discard the swab.

Publications

Abbott ID NOW™ COVID-19 assay: do not discard the swab.

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