Test Overview
Real-time PCR by Abbott Alinity Resp-4-Plex
The 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.
Not detected
* Reference ranges may change over time. Please refer to the original patient report when evaluating results.
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.
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.
Test Details
The test will be performed multiple times per day with results reported within 48 hours of receipt of specimen in the laboratory contingent upon testing capacity.
Specimen Requirements
Nasopharyngeal specimen collection:
With the head in a tilted position, insert the swab into one nostril, advancing into the nasopharynx until resistance is felt. Rotate the swab several times on the nasopharyngeal membrane to allow adequate collection of epithelial cells - a minimum of 3 "full twists" is standard to obtain a good collection; if unsure you maintained contact with the membrane, add another 1-2 full twists.
Insert swab into viral transport media, break off swab stick at the breakpoint to ensure it will fully fit into the closed tube. Fasten the cap tightly to prevent leakage.
Send to the laboratory as soon as possible. Obtaining columnar epithelial cells will enhance reliability of viral detection.
Refrigerate (2-8°C) ≤7 days
Freeze (-70°C) > 7 days