Test Catalog

Test Id : SCOVH

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Highlights

This test provides qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA from select upper respiratory tract specimens from patients under investigation (PUI) for coronavirus disease 2019 (COVID-19). Based on sequence analysis, it is predicted that this test will detect the United Kingdom (B.1.1.7), South Africa (B.1.351), and Brazil (P.1) variants.

 

Fact sheets for this emergency use authorization (EUA) assay can be found at the following links:

For health care providers: https://www.fda.gov/media/138095/download

For patients: https://www.fda.gov/media/138098/download

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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
A short description of the method used to perform the test

Transcription-Mediated Amplification

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

SARS Coronavirus-2 RNA, V

Aliases
Lists additional common names for a test, as an aid in searching

Coronavirus

COVID-19

SARS-CoV-2

SARS

COVID

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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.

Specimen Type
Describes the specimen type validated for testing

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 > or =72 hours from collection to arrive at MCL).

Necessary Information

Specimen source, race and ethnicity are required.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

See Specimen Required

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Calcium alginate-tipped swab
wood shaft swab
transport swab containing gel or charcoal additive
Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Varies Frozen (preferred) 14 days
Refrigerated 72 hours

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

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.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Undetected

Interpretation
Provides information to assist in interpretation of the test results

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.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

The FDA has issued emergency use authorization (EUA) of this assay to test human nasopharyngeal, oropharyngeal (throat), nasal mid-turbinate, and nasal swab specimens.

 

The sensitivity of the assay is dependent on the timing of the specimen collection (in relation to symptom onset), quality and type of specimen submitted.

 

The test is specific for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); therefore, the results do not exclude the possibility of infection with other respiratory viruses.

 

Undetected (ie, negative) results do not rule out coronavirus disease 2019 (COVID-19) in patients and should not be used as the sole basis for treatment or other patient management decisions. Result should be correlated with patient's history and clinical presentation.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

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

Method Description
Describes how the test is performed and provides a method-specific reference

This test is performed using the Aptima SARS-CoV-2 Assay on the Panther System. It is a viral nucleic acid sequence-amplification assay combining the principles of target capture, transcription-mediated amplification, and dual kinetic assay. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral RNA is isolated and purified from specimens using an automated magnetic microparticle method, while artificial RNA sequences are added as internal control (IC) during this process. Sequence-specific oligonucleotide probes are added to capture and bind to 2 different sequences in the ORF1ab region of the viral genome and to the internal control sequences. Both the captured probe-RNA target and probe-IC complexes undergo replication involving reverse transcriptase and RNase enzymes to generate viral RNA amplicon and IC amplicon products, both of which are then bound to different chemiluminescent nucleic acid probes. Light emitted from the labeled hybrids of probe-amplicon is detected and recorded as relative light units (RLU). Presence of viral RNA and IC amplicons is distinguished on the basis of differences in kinetics of the chemiluminescent signals generated from the 2 types of amplicon-probe hybrids. Assay results are then determined by a cut-off based on the total RLU and the kinetic curve type.(Package insert: Aptima SARS-CoV-2 Assay [Panther System]. Hologic, Inc; Doc. AW-21492-001 Rev. 002, 05/2020)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

5 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

U0003

U0005-(if applicable)

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
SCOVH SARS Coronavirus-2 RNA, V 94559-2
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
SCOVS SARS CoV-2 Specimen Source 31208-2
609471 SARS CoV-2 RNA, TMA 94559-2
CRACE Patient Race 72826-1
CETHN Patient Ethnicity 69490-1

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Create a PDF

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports