INTENDED USE

The Alinity m Resp-4-Plex assay is a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare location, from individuals suspected by their HCP of respiratory viral infection consistent with COVID-19. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2, influenza, and RSV can be similar. Testing 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.

Results are for the identification and differentiation of RNA from influenza A, influenza B, RSV, and SARS-CoV-2. The Alinity m Resp-4-Plex assay is not intended to detect influenza C virus. RNA from influenza A, influenza B, RSV, and SARS-CoV-2 is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of active infection but do not rule out bacterial infection or co-infection with other pathogens not detected by the test. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities.

Negative results do not preclude influenza A, influenza B, RSV, or 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. 

Testing with the Alinity m Resp-4-Plex assay is intended for use by trained operators who are proficient in performing tests using the Alinity m system and in vitro diagnostic procedures. The Alinity m Resp-4-Plex 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.

• The use of this assay as an in vitro diagnostic under the FDA Emergency Use Authorization (EUA) is limited to laboratories that are 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.
• Use of the Alinity m Resp-4-Plex 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 SARS-CoV-2 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 positive controls or specimens must be controlled by good laboratory practices and careful adherence to the procedures specified in the 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 the package insert).
• Detection of flu A, flu B, RSV, or SARS-CoV-2 RNA may be affected by sample collection methods, patient factors (eg, presence of symptoms), and/or stage of infection.
• Recent patient exposure to FluMist® or other attenuated influenza vaccines may cause inaccurate positive results for flu A and flu B due to the presence of attenuated viruses.
• Interference was observed for RSV when evaluated with FluMist. Recent patient exposure to FluMist or other attenuated influenza vaccines may cause inaccurate false negative RSV results.
• Interference was observed for flu A, flu B, RSV, and SARS-CoV-2 when evaluated with high concentrations of Pneumocystis jirovecii (PJP). There is a risk of false negative for flu A, B, RSV, and SARS-CoV-2 results under certain co-infection circumstances with Pneumocystis jirovecii (PJP).
• False-negative results may arise from degradation of the viral RNA during storage and transport of the specimens.
• As with any molecular test, mutations within the target regions of Alinity m Resp-4-Plex assay could affect primer and/or probe binding resulting in failure to detect the presence of virus.
• 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.
• Results should be interpreted by a trained professional in conjunction with the patient’s history and clinical signs and symptoms, and epidemiological risk factors.
• The Alinity m Resp-4-Plex assay was validated with nasopharyngeal swabs. Anterior nasal swabs (self-collected under healthcare provider (HCP) supervision or HCP-collected) are also considered acceptable specimen types, but performance has not been established. Specimen types other than nasopharyngeal and anterior nasal swabs should not be tested with this assay.
• Negative results do not preclude infection with the flu A, flu B, RSV, or SARS-CoV-2 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.
• Self-collected under supervision of or healthcare provider collected anterior nasal swabs are additional acceptable upper respiratory specimens that can be tested with the Alinity m Resp-4-Plex assay; however, performance with this specimen type has not been validated.
• Influenza was validated in the clinical study by testing archived, selected specimens only. If an influenza result is inconsistent with clinical presentation and/or other clinical and epidemiological information, FDA-cleared Influenza NAATs are available for confirmation if clinically indicated.
• A positive result indicates the detection of nucleic acid from the relevant virus. Nucleic acid may persist even after the virus is no longer viable.

Rx Only

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 Emergency Use Authorization (EUA) for use by laboratories certified under the Clinical Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet requirements to perform moderate or high complexity tests;

• This product has been authorized by FDA under an EUA for use by authorized laboratories certified under CLIA to perform moderate or high complexity tests.

• This product has been authorized only for the detection and differentiation of nucleic acid from influenza A, influenza B, Respiratory Syncytial Virus and 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 the authorization is revoked sooner.