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


Ordering Guidance


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

 

For the most up-to-date COVID-19 epidemiology and testing recommendations, visit www.cdc.gov/coronavirus/2019-ncov/index.html



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), oropharyngeal (OP ie, throat), nasal mid-turbinate, or nares/nasal swab

Supplies:

-Swab, Sterile Polyester, 10 per package (T507)

-Dacron-tipped swab with plastic shaft is acceptable

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 or pharyngeal mucosa surface to maximize recovery of cells.

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 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.

 

Specimen Type: Lower respiratory tract

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

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.


Useful For

Detection of COVID-19 illness due to 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/index.html

Method Name

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

Reporting Name

SARS Coronavirus 2 PCR Detect, 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 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.

Reference Values

Undetected

Interpretation

A "Detected" result indicates that SARS-CoV-2 RNA is present and suggests the diagnosis of 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 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 SARS-CoV-2 or SARS-related coronavirus. Additional testing with an alternative molecular method may be considered if the patient does not have signs or symptoms of COVID-19.

 

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 real-time, reverse transcription polymerase chain inhibition. Submission of a new specimen for testing is recommended.

 

Sequence analyses have predicted that this assay will detect the circulating variants reported by the U.S. Centers for Disease Control and Prevention (www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/scientific-brief-emerging-variants.html), such as the United Kingdom (B.1.1.7), South Africa (B.1.351), and Brazil (P.1) variants.

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. 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

3. 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

4. Centers for Disease Control and Prevention. Overview of testing for SARS-CoV-2. Available at www.cdc.gov/coronavirus/2019-ncov/index.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) Performed

Monday through Sunday

Report Available

Same day/1 to 3 days

Test Classification

This test has received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration and is modified from the manufacturer's instructions with a bridging study. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

U0003

U0005-(If applicable)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
COVID SARS Coronavirus 2 PCR Detect, V 94500-6

 

Result ID Test Result Name Result LOINC Value
608827 SARS-CoV-2 RNA by PCR 94500-6
CVDS SARS-CoV-2 Specimen Source 31208-2
CRACE Patient Race 72826-1
CETHN Patient Ethnicity 69490-1

Reflex Tests

Test ID Reporting Name Available Separately Always Performed
TATCH TAT <=2 days additional charge No No

Testing Algorithm

In response to the new Centers for Medicare and Medicaid Services (CMS) payment strategy for COVID-19 diagnostic testing, a bill-only code will be added for orders that meet the new CMS turn-around-time requirement. For additional information refer to www.cms.gov/newsroom/press-releases/cms-changes-medicare-payment-support-faster-covid-19-diagnostic-testing.