Sign in →

Test ID SCOV2 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2), Molecular Detection, Varies


Advisory Information


Due to the non-specific clinical presentation of coronavirus disease 2019 (COVID-19) during the early stages of the illness, testing for other respiratory infections (eg, influenza) may be warranted.

 

For the most up-to-date severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) epidemiology and testing recommendations, visit https://www.cdc.gov/coronavirus/2019-ncov/index.html



Shipping Instructions


 



Specimen Required


Preferred:

Specimen Type: Nasopharyngeal swab (Eswabs are not acceptable)

Container/Tube: Sterile container with transport media

Specimen Volume: Swab in 3 mL of media

Collection Instructions:

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

2. Swab must be placed into viral transport media (eg, M4-RT, M4 or M5), saline, phosphate buffered saline (PBS) or minimum essential media (MEM). 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

 

Acceptable:

Specimen Type: Oropharyngeal (throat) swab, nasal mid-turbinate, or nares/nasal swab

Supplies:

-Culturette (BBL Culture Swab) (T092)

-Swab, Sterile Polyester (T507)

Container/Tube: Sterile container with transport media

Preferred: BBL Culture Swab (Eswabs are not acceptable)

Acceptable: Dacron-tipped swab with plastic handle

Specimen Volume: Swab in 3 mL of media

Collection Instructions: Swab must be placed into viral transport media (eg, M4-RT, M4, or M5), saline, PBS or MEM. 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 Type: Lower respiratory tract

Sources: Bronchoalveolar lavage (BAL), bronchial washings, sputum, tracheal aspirate/secretion

Container/Tube: Sterile container

Specimen Volume: 1 mL

Additional Information: Do not aliquot into viral transport media.


Useful For

Detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2)

 

This test should not be performed unless the patient meets clinical and epidemiologic criteria for testing.

Method Name

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

Reporting Name

SARS Coronavirus-2, PCR, Varies

Specimen Type

Varies

Specimen Minimum Volume

Swab in 0.5 mL of media
Lower respiratory specimens: 1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred) 7 days
  Frozen  7 days

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.

Reference Values

Undetected

Interpretation

A positive (detected) test result indicates that the patient is presumptively infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The test does not indicate the stage of infection. Laboratory test results should always be considered in the context of clinical observations and epidemiologic data in making a final diagnosis.

 

A negative (undetected) test result suggests that the patient is not infected with SARS-CoV-2; however, this may be influenced by the stage of the infection and the quality of the sample that was collected.

An indeterminate result suggests that the patient may have a very low amount of viral nucleic acid present in the sample that does not reach the threshold to be considered positive (detected) by the assay. Repeat testing on a new sample may be considered, if clinically indicated.

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. Patel A, Jernigan DB: Initial Public Health Response and Interim Clinical Guidance for the 2019 Novel Coronavirus Outbreak United States, December 31, 2019 - February 4, 2020. MMWR Morb Mortal Wkly Rep 2020;69:140-146. doi: dx.doi.org/10.15585/mmwr.mm6905e1

3. 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

4. Rodino KG, Espy MJ, Buckwalter SP, et al: Evaluation of saline, phosphate buffered saline and minimum essential medium as potential alternatives to viral transport media for SARS-CoV-2 testing. J Clin Microbiol 2020 Mar 30. doi: 10.1128/JCM.00590-20

Day(s) and Time(s) Performed

Monday through Saturday

Analytic Time

Same day/1 day

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. Independent review by the U.S. Food and Drug Administration is pending.

CPT Code Information

U0003 (Rochester)

87635 (Florida)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
SCOV2 SARS Coronavirus-2, PCR, Varies 94500-6

 

Result ID Test Result Name Result LOINC Value
COVS SARS Coronavirus-2 Source 31208-2
608442 SARS Coronavirus-2, PCR 94500-6

Forms

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