Test Catalog

Test Id : CVOOA

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

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).

 

This test ID combines 2 molecular assays designed for detection of SARS-CoV-2 into 1 orderable test. All of the assays used for testing have received emergency use authorization (EUA) from the FDA. Testing will be performed with 1 of the following assays:

-Abbott m2000rt RealTime SARS-CoV-2 assay (Abbott Molecular Inc.)

-Abbott Alinity m SARS-CoV-2 AMP assay (Abbott Molecular Inc.)

 

URL links to the fact sheets for each of these EUA assays are provided in the Method Description section.

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

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 RNA, PCR, V

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

Coronavirus

COVID-19

COVID

SARS-CoV-2

SARS

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

Specimen Type
Describes the specimen type validated for testing

Varies

Ordering Guidance

Due to the non-specific clinical presentation of coronavirus disease 2019 (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 https://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 72 hours or more from collection to arrive at MCL).

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
CVOAS SARS-CoV-2 Spec. Source Bronchoalveolar Lavage
Oropharynx, Nasopharynx
Nares
Nasal
Nasal mid-turbinate
Nasal Washing
Nasopharyngeal Aspirate
CARAC Patient Race American Indian or Alaska Native
Asian, Black or African American
Native Hawaiian/Other Pacific Islander
White
Other Race
Refused to Answer
Unknown
CAETH Patient Ethnicity Hispanic or Latino
Not Hispanic or Latino
Not Obtainable
Refused
Asked but Unknown
Unknown

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

Specimen Type: Nasopharyngeal (NP), oropharyngeal (OP; ie, throat).

Supplies: Swab, Sterile Polyester (T507)

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 https://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. 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.

 

Specimen Type: Lower respiratory tract

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

Container/Tube: Sterile container

Specimen Volume: Minimum of 2.2 mL

Additional Information: Do not aliquot into viral transport media glass tubes, vacutainer tubes, or tubes with push caps.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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, or transport swab containing gel or charcoal additive Reject
Transport media tubes containing the entire swab (shaft and knob attached) Reject
Glass transport media tubes 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

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

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 coronavirus disease 2019 (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, 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
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, as well as the quality and type of the 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 real-time reverse transcription polymerase chain reaction (RT-PCR) 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 FDA has provided emergency use authorization (EUA) of these assays for testing human nasopharyngeal and oropharyngeal swab specimens. Bronchoalveolar lavage fluid specimens were validated in a manner consistent with CLIA requirements.

 

The sensitivity of the assays is dependent on the timing of the specimen collection (in relation to symptom onset), as well as the quality and type of the specimen submitted for testing.

 

The test is specific for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and positive test results do not exclude the possibility of concurrent 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;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/hcp/clinical-criteria.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

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

Abbott m2000rt assay:

 

The Abbott m2000 Sample Preparation System kit is used with the automated Abbott m2000sp sample preparation system to extract and purify viral RNA from human nasopharyngeal specimens, based on magnetic particle technology. Amplification and detection of target sequence is performed on the Abbott m2000rt instrument. This kit contains primers and probes targeting the N and RdRp genes specific for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). An internal RNA control is also added to the extraction reagents and carried through the entire process in each specimen to ensure adequate extraction has occurred free of inhibitory substances.(Package insert: Abbott RealTime SARS-CoV-2. Abbott Molecular Inc; 03/2020)

 

Fact sheets for this EUA assay can be found at the following URL:

For health care providers: https://www.fda.gov/media/136256/download

For patients: https://www.fda.gov/media/136257/download

 

Abbott Alinity m assay:

The Alinity m SARS-CoV-2 assay is a dual target assay for the RdRp and N genes.

 

An RNA sequence that is unrelated to the SARS-CoV-2 sequence is introduced into each specimen at the beginning of sample preparation. This unrelated RNA sequence is simultaneously amplified by real-time reverse transcription polymerase chain reaction (RT-PCR) and serves as an internal control (IC) to demonstrate that the process has proceeded correctly for each sample.

 

The Alinity m SARS-CoV-2 assay detects the SARS-CoV-2 virus and IC target sequences through the use of target-specific fluorescent-labeled oligonucleotide probes. The probes do not generate a signal unless they are specifically bound to the amplified product. The 2 SARS-CoV-2-specific probes are labeled with the same fluorophore and the IC-specific probe is labeled with a different fluorophore, thus allowing for simultaneous detection of both SARS-CoV-2 and IC amplified products in the same reaction vessel.(Package insert: Abbot SARS-CoV-2 AMP Procedure. Abbott Molecular Inc; 05/2020) 

 

Fact sheets for this assay can be found at the following URL:

For healthcare providers: https://www.fda.gov/media/137978/download

For patients: https://www.fda.gov/media/137981/download

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.

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

3 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
CVOOA SARS Coronavirus 2 RNA, 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.
CVOAS SARS-CoV-2 Spec. Source 31208-2
610438 SARS-CoV-2 RNA 94500-6
610439 Method Summary 62364-5
CAETH Patient Ethnicity 69490-1
CARAC Patient Race 72826-1

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 | PHP Pdf | CMS 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