Test Id : CMVLR
Cytomegalovirus (CMV) Molecular Detection, PCR, Lower Respiratory
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.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
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
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.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
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.
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 |