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


Ordering Guidance


This test should be used for symptomatic patients under investigation for coronavirus disease 2019 (COVID-19).



Shipping Instructions


Ship specimens refrigerated (if <72 hours from collection to arrive at MCL) or frozen (if ≥72 hours from collection to arrive at MCL).



Necessary Information


Specimen source, race and ethnicity are required.



Specimen Required


Preferred

Specimen Type: Nasopharyngeal (NP), oropharyngeal (OP; ie, throat), 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, M4, M4-RT, M5, phosphate buffered saline: PBS)

Media should not contain guanidine thiocyanate (GTC), such as Abbott Multi-Collect Specimen Collection Kit, Copan eNAT, PrimeStore MTM.

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 1.5 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.

 

Acceptable

Specimen Type: Nasopharyngeal (NP) 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.


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

Testing Algorithm

In response to the new Centers for Medicare and Medicaid Services (CMS) payment strategy for coronavirus disease 2019 (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.

Method Name

Transcription-Mediated Amplification

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 necessary.

 

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.

 

Based on sequence analysis, it is 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 Feb;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 Mar 5;382(10):929-936. doi: 10.1056/NEJMoa2001191

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

4. Mohammadi A, Esmaeilzadeh E, Li Y, Bosch RJ, Li JZ: SARS-CoV-2 detection in different respiratory sites: a systematic review and meta-analysis. [published online ahead of print, 2020 Jul 18]. EBioMedicine. 2020;102903. doi: 10.1016/j.ebiom.2020.102903

5. Centers for Disease Control and Prevention. Overview of testing for SARS-CoV-2. Available at https://www.cdc.gov/coronavirus/2019-ncov/index.html

6. 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 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

U0003

U0005-(if applicable)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
SCOVH SARS Coronavirus-2 RNA, V 94559-2

 

Result ID Test Result Name Result LOINC Value
609471 SARS CoV-2 RNA, TMA 94559-2
SCOVS SARS CoV-2 Specimen Source 31208-2
CRACE Patient Race 72826-1
CETHN Patient Ethnicity 69490-1

Forms

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