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Test ID COFLU Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA and Influenza Virus Type A and Type B RNA Detection, PCR, Varies

Test Down Notes

This test is currently unavailable. As an alternate, consider tests COVID and HPFLU. For additional details, see test update here


Ordering Guidance


Due to the nonspecific clinical presentation of COVID-19 and influenza during the early stages of illness, concurrent testing for these 3 respiratory tract viral pathogens may be warranted.

 

For the most up-to-date testing recommendations, visit:

www.cdc.gov/coronavirus/2019-ncov/index.html

www.cdc.gov/flu/symptoms/testing.htm



Shipping Instructions


Ship specimens refrigerated (if less than 72 hours from collection to arrive at Mayo Clinic Laboratories (MCL]) or frozen (if greater or equal to 72 hours from collection to arrive at MCL).



Specimen Required


Specimen Type: Nasopharyngeal (NP), nasal mid-turbinate, or nares/nasal swab

Supplies: Swab, Sterile Polyester (T507)

Container/Tube: Universal transport media, viral transport media, or equivalent (eg, Copan UTM-RT, BD VTM, MicroTest M4, M4-RT, M5)

Media should not contain guanidine thiocyanate (GTC).

For more information on acceptable transport media, see www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2

Specimen Volume: Entire specimen with a minimum of 1.5 mL (maximum 3 mL) of transport media

Collection Instructions:

1. Collect specimen by swabbing back and forth over nasal mucosa surface to maximize recovery of cells.

2. Swab must be placed into transport medium. Swab shaft should be broken or cut so that there is no obstruction to the sample or pressure on the media container cap.

3. Do not send in glass tubes, vacutainer tubes, or tubes with push caps.

4. Do not overfill with more than 3 mL total volume of media.

 

Specimen Type: Nasopharyngeal aspirate or nasal washings

Container/Tube: Sterile container

Specimen Volume: Minimum of 1.5 mL

Additional Information: Do not aliquot into viral transport media, glass tubes, vacutainer tubes, or tubes with push caps.


Secondary ID

610293

Useful For

Detection and differentiation of COVID-19 illness (due to SARS-CoV-2) and influenza A and B viral infection in a single test using upper respiratory tract specimens

 

See following websites on indications and recommendations for testing:

www.cdc.gov/coronavirus/2019-ncov/index.html

www.cdc.gov/flu/symptoms/testing.htm

Method Name

Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR)

Reporting Name

SARS-CoV-2 and Influenza A+B PCR, V

Specimen Type

Varies

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time
Varies Frozen (preferred) 14 days
  Refrigerated  72 hours

Clinical Information

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a positive-sense, single-stranded RNA virus that causes COVID-19. Like other coronaviruses that infect humans, SARS-CoV-2 can cause both upper and lower respiratory tract infection. Symptoms can range from mild (ie, the common cold) to severe (ie, pneumonia) in both healthy and immunocompromised patients. SARS-CoV-2 transmission occurs primarily via respiratory droplets. During the early stages of COVID-19, symptoms maybe nonspecific and resemble other common respiratory tract infections, such as influenza. If testing for other respiratory tract pathogens is negative, specific testing for SARS-CoV-2 may be warranted.

 

SARS-CoV-2 is likely to be at the highest concentrations in the nasopharynx during the first 3 to 5 days of symptomatic illness. As the disease progresses, the viral load tends to decrease in the upper respiratory tract, at which point lower respiratory tract specimens (eg, sputum, tracheal aspirate, bronchoalveolar fluid) would be more likely to have detectable SARS-CoV-2.

 

Influenza, also known as the "flu," is an acute, contagious respiratory illness caused by influenza A, B, and C viruses. Of these, only influenza A and B are thought to cause significant disease, with infections due to influenza B usually being milder than infections with influenza A. Influenza A viruses are further categorized into subtypes based on the 2 major surface protein antigens: hemagglutinin (H) and neuraminidase (N).

 

Common symptoms of influenza infection include fever, chills, sore throat, muscle pains, severe headache, weakness, fatigue, and a nonproductive cough. Certain patients, including infants, the elderly, the immunocompromised, and those with impaired lung function, are at risk for serious complications.

 

In the northern hemisphere, annual epidemics of influenza typically occur during the fall or winter months. However, the peak of influenza activity can occur as late as April or May, and the timing and duration of flu seasons vary.

 

Influenza infection may be treated with supportive therapy, as well as antiviral drugs such as the neuraminidase inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza). These drugs are most effective when given within the first 48 hours of infection, so prompt diagnosis and treatment are essential for proper management.

Reference Values

Undetected

Cautions

The US Food and Drug Administration has provided emergency use authorization of this test for testing upper respiratory tract specimens only. The assay is not authorized currently to test lower respiratory tract specimens, such as sputum, bronchial washing, or bronchoalveolar lavage fluid.

 

The sensitivity of the assay is dependent on the timing of the specimen collection (in relation to symptom onset), quality, and type of the specimen submitted for testing. This test should not be performed unless the patient meets clinical and epidemiologic criteria for testing.

 

The test is specific for detection of SARS-CoV-2, influenza A and B viruses, and positive test results do not exclude the possibility of concurrent infection with other respiratory viruses. This assay does not distinguish among the different subtypes of influenza A virus.

 

Undetected (ie, negative) results do not rule out SARS-CoV-2, influenza A, or influenza B infection in patients and should not be used as the sole basis for treatment or other patient management decisions. A negative result for the influenza A viral RNA polymerase chain reaction (PCR) assay does not rule out the presence of this viral infection, as mutations in the PCR target region of this virus can cause false-negative test results. Results should be correlated with patient's history and clinical presentation. This assay detects both viable and nonviable virus.

Day(s) Performed

Monday through Sunday

Report Available

1 to 3 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test has received Emergency Use Authorization (EUA) by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

87636

NY State Approved

Yes