Alinity m SARS-CoV-2 Assay

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 SARS-CoV-2 in nasal, nasopharyngeal (NP) and oropharyngeal (OP) swabs, and bronchoalveolar lavage (BAL) specimens collected from individuals suspected of COVID-19 by their healthcare provider (HCP), as well as nasal, NP and OP swabs collected from any individual, including individuals without symptoms or other reasons to suspect COVID-19 infection. Testing of non-pooled specimens is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.§263a, that meet requirements to perform moderate or high complexity tests. 

This test is also for the qualitative detection of nucleic acid from the SARS-CoV-2 in pooled samples containing up to 5 individual upper respiratory specimens (i.e., nasal, NP, and OP swabs) that are collected by an HCP using individual vials containing transport media. Testing of pooled specimens is limited to laboratories certified under CLIA, 42 U.S.C §263a, that meet requirements to perform 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 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. Laboratories within the United States and its territories are required to report all 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. Negative results from pooled testing should not be treated as definitive. If a patient’s clinical signs and symptoms are inconsistent with a negative result and if results are necessary for patient management, then the patient should be considered for individual testing. Specimens included in pools with a positive result must be tested individually prior to reporting a result. Specimens with low viral loads may not be detected in sample pools due to the decreased sensitivity of pooled testing.

The Alinity m SARS-CoV-2 assay is intended for use by qualified and trained 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 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).
• 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.
• The Alinity m SARS-CoV-2 assay was validated with nasopharyngeal swabs. Nasal (self-collected under healthcare provider (HCP) supervision or HCP-collected) and oropharyngeal swab specimens as well as bronchoalveolar lavage specimens are also considered acceptable specimen types, but performance has not been established.
• 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.
• Samples should only be pooled when testing demand exceeds laboratory capacity and/or when testing reagents are in short supply.
• Use of the Alinity m SARS-CoV-2 assay in a general asymptomatic screening population is intended to be used as part of an infection control plan, that may include additional preventative measures, such as a predefined serial testing plan or directed testing of high-risk individuals. Negative results should be considered presumptive and do not preclude current or future infection obtained through community transmission or other exposures. Negative results must be considered in the context of an individual’s recent exposures, history, and presence of clinical signs and symptoms consistent with COVID-19.
• Asymptomatic individuals infected with COVID-19 may not shed enough virus to reach the limit of detection of the test, giving a false negative result.
• Specimens with low viral loads may not be detected in sample pools due to the decreased sensitivity of pooled testing.
• Sample pooling has only been validated using nasopharyngeal swab specimens.

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

• This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;
• This product has been authorized by FDA under an EUA for use by laboratories certified under CLIA, to perform moderate or high complexity tests;
• This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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 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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