Test Catalog

Test Id : CMVLR

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Cytomegalovirus (CMV) Molecular Detection, PCR, Lower Respiratory

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Overview

Test Catalog

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

Rapid qualitative detection of cytomegalovirus (CMV) DNA in lower respiratory specimens

 

This test is not intended for the monitoring of CMV disease progression or response to therapy.

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

Real-Time Polymerase Chain Reaction (PCR)/DNA Probe Hybridization

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

Cytomegalovirus, PCR, Lower Resp

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

CMV Detection by Real-Time PCR

Cytomegalovirus PCR

CMVLR

Lower respiratory CMV

Specimen Type
Describes the specimen type validated for testing

Varies

Ordering Guidance

For plasma specimens, order CMVQN / Cytomegalovirus (CMV) DNA Detection and Quantification by Real-Time PCR, Plasma.

Necessary Information

Specimen source is required.

ORDER QUESTIONS AND ANSWERS

Question ID Description Answers
CMVSS Specimen source

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

Specimen Type: Lower respiratory

Source: Bronchial washing, bronchoalveolar lavage, fluid/washings from lung, sputum, tracheal secretions, tracheal aspirates

Container/Tube:

Preferred: Sterile, screwcap, 5-mL aliquot tube

Acceptable: Sterile container

Specimen Volume: 1 mL

Collection Instructions: Do not centrifuge.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.5 mL

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

Lower respiratory swab
Calcium alginate-tipped swab
Wood swab
Transport swab containing gel
Feces
Paraffin blocks
Tissue specimens
Tissue biopsy
Bronchial brushings
Heat-inactivated specimens
Lower respiratory in transport media 		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 (preferred) 7 days
Frozen 7 days

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

Rapid qualitative detection of cytomegalovirus (CMV) DNA in lower respiratory specimens

 

This test is not intended for the monitoring of CMV disease progression or response to therapy.

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

Cytomegalovirus (CMV) is a double-stranded DNA virus of the Herpesviridae family. CMV is transmitted through infected body fluids, as well as through sexual contact, organ transplantation, and intrauterine transmission during pregnancy. CMV infection may be asymptomatic but can cause a wide range of symptoms in immunocompromised individuals. Detection of CMV DNA in lower respiratory specimens may support the clinical diagnosis of CMV pneumonitis. Infection with CMV is a significant cause of morbidity and mortality in transplant recipients and other immunocompromised hosts.

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

 

Reference values apply to all ages.

Interpretation
Provides information to assist in interpretation of the test results

A positive result indicates the presence of cytomegalovirus (CMV) DNA in the patient specimen.

 

A negative result indicates the absence of CMV DNA in the patient specimen but does not rule out possible infection with CMV.

 

An invalid result indicates the inability to conclusively determine presence or absence of CMV DNA in the patient specimen.

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

This test is not validated for lung tissue or biopsy specimens; it is only validated for the lower respiratory specimens indicated in Specimen Required.

 

Negative results do not preclude cytomegalovirus (CMV) infection and should not be used as the sole basis for treatment or other patient management decisions.

 

False-negative results may occur if the viral nucleic acid is present at a level below the analytical sensitivity of the assay, if the virus has genomic mutations, insertions, deletions, or rearrangements, or if the assay is performed very early in the course of illness.

 

The performance of this test has not been established for monitoring treatment of CMV infection.

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

1. Caliendo, AM. Approach to the diagnosis of cytomegalovirus infection. UpToDate; Updated May 16, 2024. Accessed November 1, 2024. Available at www.uptodate.com/contents/approach-to-the-diagnosis-of-cytomegalovirus-infection

2. Fernholz EC, Vidal-Folch N, Hasadsri L. Rapid and direct detection of congenital cytomegalovirus using a commercial real-time PCR assay. J Clin Microbiol. 2023;61(3):e0178122. doi:10.1128/jcm.01781-22

3. Saksirisampant G, Kawamatawong T, Promsombat K, et al. A prospective study of plasma and bronchoalveolar lavage fluid CMV DNA load quantification for the diagnosis and outcome of CMV pneumonitis in immunocompromised hosts. J Clin Virol. 2022;155:105243. doi:10.1016/j.jcv.2022.105243

4. Setiabudi D, Sukur RR, Nugraha HG, Nataprawira HM. Cytomegalovirus pneumonitis in infants: The challenge in diagnosis among pediatricians. IDCases. 2023;32:e01724. doi:10.1016/j.idcr.2023.e01724

5. Prokop K, Schmitt B. Performance evaluation of a new CMV Direct PCR assay using urine, CSF and Bronchoalveolar lavage specimen types.ASM Clinical Virology Symposium. 09/11/2023

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

The Simplexa Congenital CMV (cytomegalovirus) Direct assay is a real-time polymerase chain reaction (PCR) system that enables the direct amplification and detection of CMV DNA from liquid lower respiratory specimens without nucleic acid extraction. The system consists of the Simplexa Congenital CMV Direct Reaction Mix, the LIAISON MDX (with LIAISON MDX Studio Software), the direct amplification disc, and associated accessories.

 

In the Simplexa Congenital CMV Direct assay, bifunctional fluorescent probe-primers are used together with corresponding reverse primers to amplify CMV DNA. A well-conserved region of the CMV UL83 gene is targeted to identify CMV DNA. An internal control is used to detect PCR failure or inhibition. (Package insert: Simplexa Congenital CMV Direct. Diasorin; REF MOL2255. Rev. 01, 11/2022)

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 Saturday

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 2 days

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

14 days

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

Jacksonville

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 was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

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.

87496

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
CMVLR Cytomegalovirus, PCR, Lower Resp 104760-4
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.
CMVSS Specimen Source 31208-2
621771 CMVLR, PCR 104760-4

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

Test Update Resources

Change Type Effective Date
New Test 2025-02-18
New Test 2025-02-18