1887

Journal of Medical Microbiology logo

Volume 70, Issue 7

Acceptable performance of the Abbott ID NOW among symptomatic individuals with confirmed COVID-19 Open Access

Abstract

The ID NOW is FDA approved for the detection of SARS-CoV-2 in symptomatic individuals within the first 7 days of symptom onset for COVID-19 if tested within 1 h of specimen collection.

Clinical data on the performance of the ID NOW are limited, with many studies varying in their study design and/or having small sample size.

In this study we aimed to determine the clinical performance of the ID NOW compared to conventional RT-PCR testing.

Adults with COVID-19 in the community or hospital were recruited into the study. Paired throat swabs were collected, with one throat swab transported immediately in an empty sterile tube to the laboratory for ID NOW testing, and the other transported in universal transport media and tested by an in-house SARS-CoV-2 RT-PCR assay targeting the E gene.

In total, 133 individuals were included in the study; 129 samples were positive on either the ID NOW and/or RT-PCR. Assuming any positive result on either assay represents a true positive, positive per cent agreement (PPA) of the ID NOW compared to RT-PCR with 95 % confidence intervals was 89.1 % (82.0–94.1%) and 91.6 % (85.1–95.9%), respectively. When analysing individuals with symptom duration ≤7 days and who had the ID NOW performed within 1 h (=62), ID NOW PPA increased to 98.2 %.

Results from the ID NOW were reliable, especially when adhering to the manufacturer’s recommendations for testing.

  • Received:
  • Accepted:
  • Published Online:
Keyword(s): COVID-19 diagnostics , ID NOW and rapid SARS-CoV-2 test
© 2021 The Authors
  • This is an open-access article distributed under the terms of the Creative Commons Attribution License. The Microbiology Society waived the open access fees for this article.
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2021-07-26
2024-04-19
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References

  1. United States Food and Drug Administration ID now COVID-19 – instructions for use; 2020 https://www.fda.gov/media/136525/download
  2. Thwe PM, Ren P. How many are we missing with ID NOW COVID-19 assay using direct nasopharyngeal swabs? Findings from a mid-sized academic hospital clinical microbiology laboratory. Diagn Microbiol Infect Dis 2020; 98:115123 [View Article] [PubMed]
     [Google Scholar]
  3. Basu A, Zinger T, Inglima K et al. Performance of Abbott ID NOW COVID-19 rapid nucleic acid amplification test using nasopharyngeal swabs transported in viral transport media and dry nasal swabs in a New York city academic institution. J Clin Microbiol 2020; 58:e01136–20 [View Article] [PubMed]
     [Google Scholar]
  4. Zhen W, Smith E, Manji R, Schron D, Berry G. Clinical evaluation of three sample-to-answer platforms for the detection of SARS-CoV-2. J Clin Microbiol 2020; 58:e00783–20 [View Article] [PubMed]
     [Google Scholar]
  5. Rhoads DD, Cherian SS, Roman K et al. Comparison of Abbott ID Now, DiaSorin Simplexa, and CDC FDA emergency use authorization methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from individuals diagnosed with COVID-19. J Clin Microbiol 2020; 58:e00760–20 [View Article] [PubMed]
     [Google Scholar]
  6. Harrington A, Cox B, Snowdon J et al. Comparison of Abbott ID Now and Abbott m2000 methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from symptomatic patients. J Clin Microbiol 2020; 58:e00798–20 [View Article] [PubMed]
     [Google Scholar]
  7. Smithgall MC, Scherberkova I, Whittier S, Green DA. Comparison of Cepheid xpert xpress and Abbott ID now to Roche Cobas for the rapid detection of SARS-COV-2. J Clin Virol 2020; 128:104428 [View Article] [PubMed]
     [Google Scholar]
  8. Fung B, Gopez A, Servellita V, Arevalo S, Ho C et al. Direct comparison of SARS-CoV-2 analytical limits of detection across seven molecular assays. J Clin Microbiol 2020; 58:e01535–20 [View Article] [PubMed]
     [Google Scholar]
  9. Moore NM, Li H, Schejbal D, Lindsley J, Hayden MK. Comparison of two commercial molecular tests and a laboratory-developed modification of the CDC 2019-nCoV Reverse transcriptase PCR assay for the detection of SARS-CoV-2. J Clin Microbiol 2020; 58:e00938–20 [View Article] [PubMed]
     [Google Scholar]
  10. Mitchell SL, George KS. Evaluation of the COVID19 ID NOW EUA assay. J Clin Virol 2020; 128:104429 [View Article] [PubMed]
     [Google Scholar]
  11. Lephart PR, Bachman MA, LeBar W et al. Comparative study of four SARS-CoV-2 Nucleic Acid Amplification Test (NAAT) platforms demonstrates that ID NOW performance is impaired substantially by patient and specimen type. Diagn Microbiol Infect Dis 2020; 99:115200 [View Article] [PubMed]
     [Google Scholar]
  12. Comer SW, Fusk D. An extended laboratory validation study and comparative performance evaluation of the Abbott ID NOW COVID-19 assay in a coastal California tertiary care medical center. medRxiv
     [Google Scholar]
  13. Cradic K, Lockhart M, Ozbolt P et al. Clinical evaluation and utilization of multiple molecular in vitro diagnostic assays for the detection of SARS-CoV-2. Am J Clin Pathol 2020; 154:201–207 [View Article] [PubMed]
     [Google Scholar]
  14. Procop GW, Brock JE, Reineks EZ et al. A comparison of five SARS-CoV-2 molecular assays with clinical correlations. Am J Clin Pathol 2020aqaa181
     [Google Scholar]
  15. Serei VD, Cristelli R, Joho K et al. Comparison of Abbott ID NOW COVID-19 rapid molecular assay to cepheid Xpert Xpress SARS-CoV-2 assay in dry nasal swabs. Diagnostic Microbiol Infect Dis 2020; 115208:
     [Google Scholar]
  16. Jin R, Pettengill MA, Hartnett NL et al. Commercial severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) molecular assays: Superior analytical sensitivity of cobas SARS-CoV-2 relative to NxTAG CoV extended panel and ID NOW COVID-19 test. Arch Pathol Lab Med 2020; 144:1303–1310 [View Article] [PubMed]
     [Google Scholar]
  17. Ghofrani M, Casas MT, Pelz RK, Kroll C, Blum N et al. Performance characteristics of the ID NOW COVID-19 assay: a regional health care system experience. MedRxiv 2020
     [Google Scholar]
  18. AHS collection guide Alberta health services. Collection of nasopharyngeal and throat swab for detection of respiratory infection; 2017 https://www.albertahealthservices.ca/assets/wf/plab/wf-provlab-collection-of-nasopharyngeal-and-throat-swab.pdf
  19. Pabbaraju K. Development and validation of reverse transcriptase-PCR assays for the testing of SARS-COV-2. JAMMI 2020e20200026 [View Article]
     [Google Scholar]
  20. Centers for Disease Control and Prevention CDC 2019-novel Coronavirus (2019-NCoV) real-time RT-PCR diagnostic panel: For emergency use only: Instructions for use; 2019 https://www.fda.gov/media/134922/download
  21. Pinninti S, Trieu C, Pati S, Latting M, Cooper J et al. Comparing nasopharyngeal and midturbinate nasal swab testing for the identification of severe acute respiratory syndrome Coronavirus 2. Clin Infect Dis 2020; 72:1253–1255 [View Article]
     [Google Scholar]
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Acceptable performance of the Abbott ID NOW among symptomatic individuals with confirmed COVID-19
J. Med. Microbiol. 70, 001372 (2021); https://doi.org/10.1099/jmm.0.001372
/content/journal/jmm/10.1099/jmm.0.001372
/content/journal/jmm/10.1099/jmm.0.001372
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