ALINITY M
RESP-4-PLEX ASSAY
BE READY FOR THE UNPREDICTABLE
For In Vitro Diagnostic Use.
THE FUTURE OF SARS-COV-2, FLU A, FLU B AND RSV
TESTING IS UNPREDICTABLE. SOLUTIONS ARE NEEDED TO BALANCE LOW AND HIGH SEASON TESTING VOLUME.
Swings in respiratory testing volume are unpredictable and can challenge normal lab operation, impacting turnaround time on routine & critical samples. To be prepared, labs require flexibility to manage low and high volume on a high throughput, fully automated system, without interrupting routine testing volumes.
ALINITY M RESP-4-PLEX ASSAY HELPS LABS BALANCE LOW AND HIGH SEASON DEMAND
- Alinity m Resp-4-Plex delivers differentiated results of SARS-CoV-2, flu A, flu B and RSV with one sample, on Alinity m, a high throughput, flexible system.
- Alinity m allows labs to run any test, any time, helping staff balance low and high season testing demand on one platform, without interrupting routine testing or testing of clinically critical samples.
- Alinity m Resp-4-Plex is a robust assay, with highly conserved target sequences to safeguard against viral evolution.
GLOBALLY MONITORED AGAINST EMERGING VARIANTS
Abbott Pandemic Defense Coalition (APDC) is the first-of-its-kind global network dedicated to identifying, tracing and responding to disease outbreaks.
APDC has analyzed 250 SARS-CoV-2 variants against Alinity m Resp-4-Plex, finding mutations have no impact on assay performance.
UNMASK ADDITIONAL RESULTS AS NEEDED
Order up to 4 targets (SARS-CoV-2, flu A,
flu B, and RSV), with ability to mask results
Release masked results within 14 days, if needed
INTENDED USE
ALINITY M RESP-4-PLEX |
The Alinity m Resp-4-Plex assay is a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection. Results are for the identification and differentiation of RNA from flu A, flu B, RSV, and SARS-CoV-2. Flu A, flu B, RSV, and SARS-CoV-2 RNA are generally detectable in nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of flu A, flu B, RSV, or 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. The Alinity m Resp-4-Plex assay is not intended to detect influenza C virus infections. Negative results do not preclude flu A, flu 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. The Alinity m Resp-4-Plex 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. Intended User: The intended users for the Alinity m Resp-4-Plex assay are laboratory professionals. |
EXPLORE
Alinity m System
Fully integrated, automated, high throughput molecular diagnostics analyzer with high quality assays that deliver flexibility and efficiency to your lab.
Alinity m SARS-C0V-2 Assay
Alinity m SARS-CoV-2 assay offers workflow efficiency and the high throughput solution the laboratory requires today to help meet the public health needs.
Alinity m HR HPV Assay
Discover our Alinity m HR HPV assay that offers self-collection, expanding access to care for women.
References
- Alinity m Resp-4-Plex AMP Kit Package Insert 53-608585/R01.
- Data on File at Abbott.
- Alinity m Resp-4-Plex CTRL Kit Package Insert 53-608586/R01.
- Alinity m Operations Manual 54-605001/R15.