Lab POL Guide - 2023 - 122
Molecular
HOW COULD RAPID
MOLECULAR ASSAY RESULTS
MAKE A DIFFERENCE?
Clinicians often have to make immediate clinical
decisions based only on symptoms.1-3
With that in mind,
the ID NOW™ molecular platform was designed as a true
point-of-care device to improve decision-making
processes in any setting.
ID NOW™
COVID-19 2.0
EUA authorized for
near patient testing
environments4
ID NOW™
STREP A 2
Requires no culture
confirmation for
negative results6
ID NOW™
INFLUENZA A & B 2
Detects up to 20% more
true positives than RADTs5
ID NOW™
RSV
Detects up to 25%
more true positives
than RADTs7,8
1. Stein J, et al. Performance characteristics of clinical diagnosis, a clinical decision rule, and a rapid influenza test in the detection of influenza infection in a community sample of adults.
Annals of Emergency Medicine. 2005;46(5):412-9.
2. Mills J, et al. Rapid testing for respiratory syncytial virus in a paediatric emergency department: Benefits for infection control and bed management. The Journal of Hospital Infection. 2011;77(3):248-51.
3. Cohen JF, et al. Rapid antigen detection test for group A streptococcus in children with pharyngitis. Cochrane Database of Systematic Review. 2013:5-7. doi:10.1002/14651858.cd010502
4. Abbott. ID NOW COVID-19 2.0 Product Insert.
5. CFR - Code of Federal Regulations Title 21. U.S. Food & Drug Administration. Updated March 29, 2022. Accessed July 26, 2022.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=866.3328
6. ID NOW Strep A 2 Product Insert
7. Chartrand, C. et al. Diagnostic Accuracy of Rapid Antigen Detection Tests for Respiratory Syncytial Virus Infection: Systematic Review and Meta-analysis. J Clin Microbiol.
December 2015 vol. 53 no. 12 3738-3749
8. ID NOW RSV Product Insert
ID NOW™ COVID-19 2.0 has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been
authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying
the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)
(1), unless the declaration is terminated or authorization is revoked sooner.
© 2023 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners. Any photos displayed are for illustrative purposes only.
COL-15933-03 04/23
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122
22MS9092
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=866.3328
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Lab POL Guide - 2023
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