INTENDED USE

The Alinity m SARS-CoV-2 assay is a real-time reverse transcriptase (RT) polymerase chain reaction (PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasal swabs, self-collected at a health care location or collected by a healthcare worker, nasopharyngeal (NP) and oropharyngeal (OP) swabs collected by a healthcare worker or bronchoalveolar lavage fluid (BAL) from patients suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.§263a, to perform moderate or high complexity tests.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase ofinfection. 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. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.  The Alinity m SARS-CoV-2 assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Alinity m SARS-CoV-2 assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

LIMITATIONS OF THE PROCEDURE

For use under an Emergency Use Authorization only.

• This assay is for in vitro diagnostic use under FDA Emergency Use Authorization only.
• Use of the Alinity m SARS-CoV-2 assay is limited to personnel who have been trained in the procedures of a molecular diagnostic assay and the Alinity m System.
• Laboratories are required to report all positive results to the appropriate public health authorities.
• The instrument and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the positive controls or specimens must be controlled by good laboratory practices and careful adherence to the procedures specified in this package insert.
• Optimal performance of this test requires appropriate specimen collection, storage, and transport to the test site (refer to the SPECIMEN COLLECTION, STORAGE, AND TRANSPORT TO THE TEST SITE section of this package insert). The performance for testing specimens in phosphate-containing buffer has not been evaluated with the Alinity m SARS-CoV-2 assay.
• Detection of SARS-CoV-2 RNA may be affected by sample collection methods, patient factors (eg, presence of symptoms), and/or stage of infection.
• False-negative results may arise from degradation of the viral RNA during storage and transport of the specimens.
• The impacts of vaccines, antiviral therapeutics, antibiotics, chemotherapeutic or immunosuppressant drugs have not been evaluated.
• As with any molecular test, mutations within the target regions of Alinity m SARS-CoV-2 assay could affect primer and/or probe binding resulting in failure to detect the presence of virus.
• Due to inherent differences between technologies, it is recommended that, prior to switching from one technology to the next, users perform comparison studies in their laboratory to qualify technology differences. One hundred percent agreement between the results should not be expected due to aforementioned differences between technologies. Users should follow their own specific policies/procedures.
• Performance has only been established with the specimen types listed in the Intended Use. Other specimen types have not been evaluated and should not be used with this assay.
• Results should be interpreted by a trained professional in conjunction with the patient’s history and clinical signs and symptoms, and epidemiological risk factors.
• Negative results do not preclude infection with the SARS-CoV-2 virus and should not be the sole basis of a patient treatment/management or public health decision. Follow up testing should be performed according to the current CDC recommendations.

This assay is only for in vitro diagnostic use under the FDA Emergency Use Authorization.

• The Alinity m SARS-CoV-2 assay has not been FDA cleared or approved.
• This test has been authorized by the FDA under an Emergency Use Authorization for use by authorized laboratories.
• This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
• This test 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Below are links to CDC website on:

• Information for Laboratories: https://www.cdc.gov/coronavirus/2019-nCoV/lab/index.html
• Collecting, Handling and Testing Clinical Specimens: 

  https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html

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