Innovative multiplex SARS-CoV-2, Flu A, Flu B, and RSV assay to curb the COVID-19 outbreak during flu season. The Alinity m Resp-4-Plex assay offers workflow efficiency and high throughput solution the laboratory requires today to meet the public health need for differentiation of all 3 viruses:
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.
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 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.
|ABBOTT ALINITY m Resp-4-plex ASSAY Specifications1-4|
|Technology||Qualitative multiplex real-time reverse transcription PCR|
|Assay Run Time||< 115 min time to first result|
|Throughput||Up to 1080 samples in 24 hours (number of actual samples per 24-hour period may vary based on laboratory practice and workflow)|
|Assay Design||Multiplex assay to detect Flu A virus, Flu B virus, RSV and SARS-CoV-2|
|Target Region||RdRp and N-gene of the SARS-CoV-2 genome, Matrix gene of the flu A genome, Nonstructural 1 gene of the flu B genome, Matrix gene of the RSV genome|
|Specimen Types||Anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider, 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|
|Result||Cycle number/not detected|
|Minimum Sample Volume||Minimum sample volume depending on tube between 0.8 mL and 1.4 mL. Sample input volume: 0.5 mL|
|Controls||One negative and one positive control per 24 hours|
|Internal Control||Armored RNA (Pumpkin), added to each specimen and control|
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