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Test ID SARS2 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA, Varies


Advisory Information


This test should be used for symptomatic patients under investigation for coronavirus disease 2019 (COVID-19). It is not to be used for screening asymptomatic patients.



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).



Necessary Information


Specimen source is required.



Specimen Required


Specimen Type: Nasopharyngeal (NP), oropharyngeal (OP; ie, throat), nares/nasal, or nasal mid-turbinate swab

Supplies:

-Nasopharyngeal Swab (Rayon Mini-Tip Swab) (T515)

-Swab, Sterile Polyester swab (T507)

-Dacron-tipped swab with plastic shaft is acceptable

-M4-RT (T605)

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 alternative transport media, see www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2

Specimen Volume: Entire collection with a minimum of 2.2 mL (maximum 3 mL) of transport medium

Collection Instructions:

1. Collect specimen by swabbing back and forth over nasal or pharyngeal mucosa surface to maximize recovery of cells. For more information on OP swab specimen collection, see COVID-19 Oropharyngeal Collection Instructions in Special Instructions.

2. NP and OP swab specimens may be combined at collection into a single vial of transport media but only one swab is required for analysis.

3. 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.

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

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

 

Specimen Type: Nasopharyngeal aspirate, nasal washing

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.

 

Specimen Type: Lower respiratory tract

Sources: Bronchoalveolar lavage (BAL) fluid, bronchial washings, endotracheal aspirate, sputum

Container/Tube: Sterile container

Specimen Volume: Minimum of 2.2 mL

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


Useful For

Diagnosis of coronavirus disease 2019 (COVID-19) illness due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

 

Recommended only for patients who meet current clinical and/or epidemiologic criteria defined by federal, state, or local public health directives: www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html

Method Name

Real-Time Polymerase Chain Reaction (RT-PCR)

Reporting Name

SARS Coronavirus 2 RNA, 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) virus 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 illness. 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 disease, the symptoms maybe nonspecific and resemble other common respiratory infections, such as influenza. If testing for other respiratory infections is negative, specific testing for SARS-CoV-2 (COVID-19) 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.

Reference Values

Undetected

Interpretation

A Detected result indicates that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA is present and suggests the diagnosis of coronavirus disease 2019 (COVID-19). Test result 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 SARS-CoV-2 is not present in the patient's specimen. However, this result may be influenced by the stage of the infection, quality and type of specimen collected for testing. Result should be correlated with patient’s history and clinical presentation.

 

An Inconclusive result indicates that the presence or absence of SARS-CoV-2 RNA in the specimen could not be determined with certainty after repeat testing in the laboratory, possibly due to RT-PCR inhibition. Submission of a new specimen for testing is recommended.

Clinical Reference

1. Zhu N, Zhang D, Wang W, et al: A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med 2020;382(8):727-733 doi: 10.1056/NEJMoa2001017

2. Holshue M, DeBolt C, Lindquist S, et al: First Case of 2019 Novel Coronavirus in the United States. N Engl J Med 2020 Jan 31 doi: 10.1056/NEJMoa2001191

3. Loeffelholz MJ, Tang YW: Laboratory diagnosis of emerging human coronavirus infections-State of the art. Emerg Microbes Infect. 2020 (published ahead of print) doi.org/10.1080/22221751.2020.1745095

4. Centers for Disease Control and Prevention. Evaluating and testing persons for Coronavirus Disease 2019 (COVID-19). Available at www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html

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

Analytic Time

Same day/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 in testing upper respiratory tract specimens, but it is modified from the manufacturer's instructions with a bridging study in testing lower respiratory tract specimens. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

U0003

LOINC Code Information

Test ID Test Order Name Order LOINC Value
SARS2 SARS Coronavirus 2 RNA, V 94500-6

 

Result ID Test Result Name Result LOINC Value
CVDS2 SARS-CoV-2 Spec. Source 31208-2
608933 SARS-CoV-2 RNA PCR 94500-6

Forms

If not ordering electronically, complete, print, and send a General Request (T239) with the specimen.