Test Catalog

Test Id : RSARS

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

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Overview

Test Catalog

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

Rapid diagnostic test for detection of COVID-19 illness due to SARS-CoV-2

 

This test should be requested only on patients meeting current clinical and/or epidemiologic criteria defined by federal, state, or local public health directives: www.cdc.gov/coronavirus/2019-ncov/index.html

Highlights

This test provides qualitative detection of SARS-CoV-2 RNA from select upper respiratory tract specimens from patients under investigation for COVID-19.

 

This test is approved for testing human nasopharyngeal specimens under US Food and Drug Administration emergency use authorization (EUA). Fact sheets for this EUA assay can be found at the following links:

For health care providers: www.fda.gov/media/158404/download

For patients: www.fda.gov/media/158405/download

Method Name
A short description of the method used to perform the test

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

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

No

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

SARS Coronavirus 2 PCR, V

Specimen Type
Describes the specimen type validated for testing

Varies

Necessary Information

Patient’s race and ethnicity, as well as collection date, are required.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
RSAR2 SARS Coronavirus 2, Source Nasopharynx
Bronchoalveolar Lavage Fluid (BAL)
SRACE Patient's Race American Indian or Alaska Native
Asian
Black or African American
Native Hawaiian/Other Pacific Islander
White
Other Race
Refused to Answer
Unknown
SETHN Patient's Ethnicity Hispanic or Latino
Not Hispanic or Latino
Not Obtainable
Refused
Asked but Unknown
Unknown

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

Calcium alginate-tipped swab
Wooden shaft swab
Dry swab
Swab collection tubes 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 Refrigerated 72 hours

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

Rapid diagnostic test for detection of COVID-19 illness due to SARS-CoV-2

 

This test should be requested only on patients meeting current clinical and/or epidemiologic criteria defined by federal, state, or local public health directives: www.cdc.gov/coronavirus/2019-ncov/index.html

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) 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.

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.

Negative

Interpretation
Provides information to assist in interpretation of the test results

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 and the quality 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 is recommended on a newly collection specimen.

 

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 reaction inhibition. Submission of a new specimen for testing is recommended.

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

The US Food and Drug Administration has provided emergency use authorization of this test for testing human nasopharyngeal swab specimens.

 

The sensitivity of the assay is dependent on the quality of the specimen collected for testing.

 

The test is specific for SARS-CoV-2, and positive test results do not exclude the possibility of concurrent infection with other respiratory viruses.

 

Negative results do not preclude infection with SARS-CoV-2 and should not be used as the sole basis for decisions on treatment or other patient care management.

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;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. Morb Mortal Wkly Rep. 2020;69(5):140-146. doi: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;382(10):929-936. doi:10.1056/NEJMoa2001191

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

The Xpert Xpress SARS-CoV-2 plus test is an automated in vitro diagnostic test for qualitative detection of nucleic acid from SARS-CoV-2. The Xpert Xpress SARS-CoV-2 plus test is performed on GeneXpert Instrument Systems.

 

The GeneXpert Instrument Systems automate and integrate sample preparation, nucleic acid extraction and amplification, and detection of the target sequences in simple or complex samples using real-time polymerase chain reaction (RT-PCR) assays. The systems consist of an instrument, computer, and preloaded software for running tests and viewing the results. The systems require the use of single-use disposable cartridges that hold the RT-PCR reagents and host the RT-PCR process. Because the cartridges are self-contained, cross-contamination between samples is minimized. The specimen is briefly mixed by rapidly inverting the collection tube 5 times. Using the supplied transfer pipette, the sample is transferred to the sample chamber of the Xpert Xpress SARS-CoV-2 plus cartridge. The GeneXpert cartridge is loaded onto the GeneXpert Instrument System platform, which performs hands-off, automated sample processing and real-time RT-PCR for detection of viral RNA.(Package insert: Xpert Xpress SARS-CoV-2 plus. Cepheid; 302-7070, Rev A 05/2022)

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

7 days

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

Phoenix

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 account representative. 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.

87635

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
RSARS SARS Coronavirus 2 PCR, V 94500-6
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.
RSAR1 SARS Coronavirus 2, PCR 94500-6
RSAR2 SARS Coronavirus 2, Source 31208-2
SRACE Patient's Race 72826-1
SETHN Patient's 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 | 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