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• As with any molecular test, mutations within the target regions of the Abbott ID NOW COV ID-19 test
could affect primer and/or probe binding resulting in failure to detect the presence of the virus.
•
The test cannot rule out diseases caused by other bacterial or viral pathogens.
• ID NOW COVID-19 is intended for testing a swab directly without elution in viral transport media as
dilution will result in decreased detection of low positive samples that are near the limit of detection of
the test.
• Swab samples eluted in VTM are not appropriate for use in this test.
• The clinical performance has not been established in all circulating variants but is anticipated to be
reflective of the prevalent variants in circulation at the time and location of the clinical evaluation.
Performance at the time of testing may vary depending on the variants circulating, including newly
emerging strains of SARS-CoV-2 and their prevalence, which change over time.
CONDITIONS OF AUTHORIZATION FOR LABORATORIES
The ID NOW COVID-19 Letter of Authorization, along with the authorized Fact Sheet for Healthcare
Providers, the authorized Fact Sheet for Patients, and authorized labeling are available on the FDA website:
https://www.fda.gov/medical-de vices/coronavirus-disease-2019-cov id-19-emergency-use-
authorizations-medical-devices/in-vitro-diagnostics-euas.
However, to assist clinical laboratories and patient care settings (authorized laboratories
1
) using the ID
NOW COVID-19 (“your product” in the conditions below), the relevant Conditions of Authorization are
listed below:
A. Authorized laboratories using your product must include with test result reports, all authorized
Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact
Sheets may be used, which may include mass media.
B. Authorized laboratories using your product must use your product as outlined in the package insert.
Deviations from the authorized procedures, including the authorized instruments, authorized
extraction methods, authorized clinical specimen types, authorized control materials, authorized
other ancillary reagents and authorized materials required to use your product are not permitted.
C. Authorized laboratories that receive your product must notify the relevant public health authorities
of their intent to run your product prior to initiating testing.
D. Authorized laboratories using your product must have a process in place for reporting test results
to healthcare providers and relevant public health authorities, as appropriate.
E. Authorized laboratories must collect information on the performance of your product and report
to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA-Reporting@fda.hhs.gov
) and you (via
e m a il : ts.scr@abbott.com) any suspected occurrence of false positive or false negative results and
significant deviations from the established performance characteristics of your product of which
they become aware.
F. All operators using your product must be appropriately trained in performing and interpreting the
results of your product, use appropriate personal protective equipment when handling this kit, and
use your product in accordance with the authorized labeling.
G. Abbott, authorized distributor(s), and authorized laboratories using your product must ensure that
any records associated with this EUA are maintained until otherwise notified by FDA. Such records
will be made available to FDA for inspection upon request.
1
The letter of authorization refers to, “laboratories certified under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived
complexity tests and use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate
of Waiver, Certificate of Compliance, or Certificate of Accreditation” as “authorized la boratories.”
PERFORMANCE CHARACTERISTICS
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