ALINITY M
RESP-4-PLEX ASSAY
BE READY FOR THE UNPREDICTABLE
For In Vitro Diagnostic Use. Rx Only.
THE FUTURE OF SARS-COV-2, FLU A, FLU B AND RSV
TESTING IS UNPREDICTABLE. HIGH THROUGHPUT SOLUTIONS ARE NEEDED.
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 high throughput, flexible and efficient molecular testing solutions that enable fast, accurate diagnosis during peak respiratory virus seasons.
ALINITY M RESP-4-PLEX HELPS LABS BE PREPARED FOR THE UNPREDICTABLE
- 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 manage routine testing and changing respiratory volume simultaneously, delivering timely results on 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 |
| Alinity m Resp-4-Plex is a multiplexed, real-time in vitro reverse transcription polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System for the qualitative detection and differentiation of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), influenza A virus, influenza B virus, and Respiratory Syncytial Virus (RSV) in nasopharyngeal swab specimens collected from patients with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2, influenza A, influenza B, and RSV can be similar. The Alinity m Resp-4-Plex assay is intended for use in the differential detection of SARS-CoV-2, influenza A, influenza B, and/or RSV RNA and aids in the diagnosis of COVID-19, influenza, and/or RSV infections if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV-2, influenza A, influenza B, and RSV viral RNA are generally detectable in nasopharyngeal swab specimens during the acute phase of infection. This test is not intended to detect influenza C virus infections. Positive results are an indication of the presence of the identified virus, but do not rule out bacterial infection or co-infection with other pathogens not detected by the test. The agent(s) detected by the Alinity m Resp-4-Plex assay may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2, influenza A, influenza B, or RSV infections and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. |
Limitations of the Procedure
- This assay is for in vitro diagnostic use.
- 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.
- 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 the package insert.
- Performance has only been established with the specimen type listed in the Intended Use. Other specimen types have not been evaluated and should not be used with this assay. The performance of this device has not been specifically assessed in individuals without signs or symptoms of respiratory infection.
- The Alinity m Resp-4-Plex assay is only for use with nasopharyngeal (NP) swabs. Optimal performance of this test requires appropriate specimen collection, storage, and transport to the test site (refer to the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS section of the package insert). Failure to observe proper procedures in any one of these steps can lead to incorrect results.
- Detection of flu A, flu B, RSV, or SARS-CoV-2 RNA may be affected by sample collection methods, patient factors, and/or stage of infection.
- False-negative results may arise from degradation of the viral RNA during storage and transport of the specimens.
- Inadequate or inappropriate specimen collection, storage, and transport are likely to yield false test results. Training in specimen collection is highly recommended due to the importance of specimen quality. Refer to CLSI MM13-Ed214 as an appropriate resource.
- Substances in Table 6 have been evaluated and the impact of other potentially interfering substances (ie, vaccine, antiviral therapeutics, antibodies, chemotherapeutic, or immunosuppressant drugs) have not been evaluated.
- Due to inherent differences between technologies, it is recommended that, prior to switching from 1 technology to the next, users perform comparison studies in their laboratory to evaluate 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 Resp-4-Plex assay has not been validated for the testing of pooled specimens or the screening of specimens from asymptomatic individuals.
- Results should be interpreted by a trained professional in conjunction with the patient’s history, clinical signs and symptoms, and epidemiological risk factors.
- The Alinity m Resp-4-Plex assay may not be able to distinguish between existing viral strains and new variants as they emerge.
- Negative results do not preclude infection with 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 Centers for Disease Control and Prevention (CDC) recommendations.
- Positive and negative predictive values are highly dependent on prevalence. The likelihood of a negative result being false is higher during peak activity when prevalence of disease is high. The likelihood of a positive result being false is higher during periods when prevalence is moderate to low.
- The performance of the Alinity m Resp-4-Plex assay has not been specifically evaluated in a population known to be vaccinated against illnesses caused by any of the assay analytes (flu A, flu B, RSV, or SARS-CoV-2 [COVID-19]).
- The clinical performance has not been established in all circulating variants of SARS-CoV-2 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.
- Due to low prevalence during the prospective clinical study, 0 flu B positives were obtained, and the clinical validation relied solely on retrospective samples.
- Cycle number (CN) value should not be used to assess viral levels.
- Performance characteristics for flu A were established when flu A/H1 and A/H3 were predominant. When other flu A viruses are emerging, performance characteristics may differ.
- If infection with a novel flu A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, collect specimens with appropriate infection control precautions for novel virulent influenza viruses and send to state or local health department for testing. Do not attempt viral culture in these cases unless a BSL 3+ facility is available to receive and culture specimens.
- If infection with SARS-CoV-2 is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions. Refer to the CDC Interim Guidelines for Collecting and Handling of Clinical Specimens for COVID-19 Testing for more information. https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical specimens.html. Viral culture should not be attempted in cases of positive results for SARS-CoV-2 and/or any similar microbial agents unless a facility with an appropriate level of laboratory biosafety (eg, BSL 3 and BSL 3+, etc.) is available to receive and culture specimens.
- Report test results to relevant public health authorities, as required.
- 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.
- During preparation of samples, compliance with good laboratory practices is essential to minimize the risk of cross-contamination between samples and the inadvertent introduction of ribonucleases (RNases) into samples during and after the extraction procedure.
- Proper aseptic technique should always be used when working with RNA.
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References
- Alinity m Resp-4-Plex AMP Kit Package Insert 53-608210/R1.
- Data on File at Abbott.
- Alinity m Resp-4-Plex CTRL Kit Package Insert 53-608213/R1.
- Alinity m Operations Manual 54-605001/R13.