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ID NOW COVID-19
For Use Under an Emergency Use Authorization – US only (EUA)
For use with the ID NOW Instrument
For use with anterior nasal, throat or nasopharyngeal specimens
For in vitro Use
Rx Only
INTENDED USE
ID NOW COVID-19 assay performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic
test utilizing an isothermal nucleic acid amplification technology intended for the qualitative detection of
nucleic acid from the SARS-CoV-2 virus in direct anterior nasal (nasal), nasopharyngeal or throat swabs
from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of
the onset of symptoms. Testing is limited to laboratories certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high,
moderate, or waived complexity tests. The ID NOW COVID-19 assay is also authorized for 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.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in
respiratory samples during the acute phase of infection. Positive results are indicative of the presence of
SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary
to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with
other viruses. The agent detected may not be the definite cause of disease. Testing facilities within the
United States and its territories are required to report all results to the appropriate public health authorities.
Negative results should be treated as presumptive and, if inconsistent with clinical signs and symptoms or
necessary for patient management, should be tested with different authorized or cleared molecular tests.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient
management decisions. Negative results should be considered in the context of a patient’s recent
exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.
The ID NOW COVID-19 test is intended for use by medical professionals or trained operators who are
proficient in performing tests using the ID NOW Instrument. The ID NOW COVID-19 test is only for use
under the Food and Drug Administration’s Emergency Use Authorization.
SUMMARY AND EXPLANATION OF THE TEST
Coronaviruses are a large family of viruses which may cause illness in animals or humans. SARS-CoV-2 is
an enve loped, single-stranded RNA virus of the β genus. The virus can cause mild to severe respiratory
illness and has spread globally, including the United States.
ID NOW COVID-19 is a rapid (13 minutes or less), instrument-based isothermal test for the qualitative
detection and diagnosis of SARS-CoV-2 from nasal, nasopharyngeal and throat swabs. The ID NOW
Instrument has a small footprint and easy to use graphical user interface for convenience within a busy
hospital or near patient testing environments. The ID NOW CO V ID-19 kit contains all components required
to carry out an assay for SARS-CoV-2 on the ID NOW Instrume nt.
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