Four Viruses, One Swab, One Report
Waking up with a runny nose wouldn't be cause for alarm in "normal times." However, that's all changed thanks to COVID-19. Now the slightest runny nose or cough can cause alarm. Is it COVID-19? Is it just a cold? The flu? Amid this pandemic, distinguishing one respiratory illness from another has never been so important.
Even though we're experiencing a mild influenza season due to social distancing and additional COVID-19 precautions, combining the COVID-19 pandemic with any infection season can create anxiety about the unknown. For some, concern about the flu has taken a backseat to concern about COVID-19, but that isn't a reason to overlook the effect other respiratory illnesses might have on your health.
Influenza and COVID-19, along with the colder months pointing to increases in respiratory illnesses such as respiratory syncytial virus (RSV), make having answers regarding your health especially crucial.
That's why we've developed AlinityTM m Resp-4-Plex, a new assay running on our advanced Alinity m system that tests for COVID-19, flu A, flu B, and RSV using only one swab. The ability to use just one swab during a healthcare visit, rather than four separate tests, aims to decrease discomfort, lessen cost demands for doctors and lab workers, and eliminate unnecessary stress for everyone.
Minimizing the number of swabs used and time spent in a healthcare setting, like a doctor's office, has never been more important as COVID-19 cases in the U.S. continue to surge.
Not only can receiving streamlined answers about the health of you and your loved ones provide peace of mind — it can help you make informed next-steps on how to proceed with treatment and possibly prevent disease transmission.
The benefits of simultaneous testing for infectious diseases
Alinity m Resp-4-Plex's simultaneous testing will not only increase convenience and decrease discomfort for the patient — it aims to help stretched healthcare workers and save high demand testing supplies as well, by increasing laboratory and hospital efficiency and decreasing resources (such as swabs) used. These four common respiratory illnesses are posing stress to an already burdened healthcare and laboratory system:
- Influenza types A and B are known to cause seasonal flu epidemics annually in the U.S.
- RSV is a common respiratory virus that typically causes mild, common-cold-type symptoms but can be severe for both young infants and older adults.
- And, of course, COVID-19 is the latest, now common virus the world is battling.
These four common viruses share a variety of common symptoms (i.e. cough, fever, and fatigue), making distinguishing one from the other more difficult.
The test will run on our Alinity m platform, our most advanced laboratory instrument which uses Polymerase Chain Reaction (PCR) technology. This technology is known for its high sensitivity in detecting infectious diseases.
Alinity m also provides true random access, meaning that any compatible test can be run at any time. This flexibility allows for the testing of multiple infectious diseases while still producing fast results — ultimately improving lab speed.
When it comes to your health, you deserve flexibility and speed. You deserve an easier path for finding peace of mind. We're committed to providing needed answers in the most comfortable, simple way.
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 influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV) and SARS-CoV-2 in nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in 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.
For in vitro diagnostic use. Rx Only.
IMPORTANT SAFETY INFORMATION
For use under an Emergency Use Authorization only.
- This assay is for in vitro diagnostic use under FDA Emergency Use Authorization only.
- 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 this 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 this 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.
- 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.
- Results should be interpreted by a trained professional in conjunction with the patient's history and clinical signs and symptoms, and epidemiological risk factors.
- 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 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.
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 only for the detection of nucleic acid from 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 diagnostic tests 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 authorization is revoked sooner