- This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
- Negative results should be treated as presumptive and tested with an alternative FDA authorized molecular assay.
- False-negative results may occur if a specimen is improperly collected, transported, or handled. False-negative results may also occur if amplification inhibitors are present in the specimen, or if inadequate levels of viruses are present in the specimen. 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.
- As with any molecular test, mutations within the target regions of the Abbott ID NOW COVID-19 test could affect primer and/or probe binding resulting in failure to detect the presence of the virus.
- This test has not been FDA cleared or approved; this test has been authorized by FDA under a EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, in a patient care settings operating under a CLIA Certificate of Waiver.
- STAT Research, by offering this test, does not replace the advice or care of the patient’s physician. It is intended for educational purposes. The lab test result is not a medical diagnosis, a treatment, or a form of medical advice. Patients are solely responsible for promptly talking with my physician about the lab test results. I understand that only my health care provider can interpret the test results.
- Payment for this test is required prior to service. This test cannot be billed to insurance, or a third-party payor such as medicare, Medicaid, or any other state or federal health program.