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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


Advisory Information


Due to the non-specific clinical presentation of coronavirus disease 2019 (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 for COVID-19 and influenza, visit:

www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html

www.cdc.gov/flu/symptoms/testing.htm#anchor_1596736120603



Shipping Instructions


Ship specimens refrigerated (if less than 72 hours from collection to arrive at 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 https://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.


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 Special Container
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 coronavirus disease 2019 (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

Interpretation

A "Detected" result indicates that the specific virus is present and suggests infection with the virus. Test results should always be considered in the context of patient's clinical history, physical examination, and epidemiologic exposures when making the final diagnosis.

 

An "Undetected" result indicates that the specific virus is not present in the patient's specimen. However, this result may be influenced by the stage of the infection, quality, and type of the specimen collected for testing. Result should be correlated with patient’s history and clinical presentation.

 

An "Indeterminate" result suggests that the patient may be infected with a variant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or SARS-related coronavirus. Additional testing with an alternative molecular method is recommended on a newly collection specimen may be considered if the patient does not have signs and/or symptoms of coronavirus disease 2019 (COVID-19).

 

An "Inconclusive" result indicates that the presence or absence of the specific virus in the specimen could not be determined with certainty after repeat testing in the laboratory, possibly due to reverse transcription-polymerase chain reaction (RT-PCR) inhibition. Submission of a new specimen for testing is recommended.

Clinical Reference

1. Loeffelholz MJ, Tang YW: Laboratory diagnosis of emerging human coronavirus infections-the state of the art. Emerg Microbes Infect. 2020;9(1):747-756. doi: 10.1080/22221751.2020.1745095

2. Mohammadi A, Esmaeilzadeh E, Li Y, Bosch RJ, Li JZ: SARS-CoV-2 detection in different respiratory sites: a systematic review and meta-analysis. EBioMedicine. 2020 Sep;59:102903. doi: 10.1016/j.ebiom.2020.102903

3. Centers for Disease Control and Prevention. Overview of testing for SARS-CoV-2. Available at www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html

4. Centers for Disease Control and Prevention. Information for clinicians on influenza virus testing.  Available at www.cdc.gov/flu/professionals/diagnosis/index.htm

5. Food and Drug Administration. FAQs on diagnostic testing for SARS-CoV-2. Available at www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2

Day(s) and Time(s) Performed

Monday through Sunday; Varies

Analytic Time

1 day

Test Classification

This test has received Emergency Use Authorization (EUA) by the U.S. 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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
COFLU SARS-CoV-2 and Influenza A+B PCR, V 95380-2

 

Result ID Test Result Name Result LOINC Value
610295 Influenza A RNA PCR 92142-9
610296 Influenza B RNA PCR 92141-1
610294 SARS CoV-2 RNA PCR 94500-6
CFLUS SARS-CoV-2 & Flu A/B Specimen Source 31208-2
CFRAC Patient Race 72826-1
CFETH Patient Ethnicity 69490-1