Test Catalog

Test Id : CMVPV

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Cytomegalovirus (CMV) Molecular Detection, PCR, Varies

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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

 

This test is not intended for the monitoring of CMV disease progression.

Highlights

This test provides qualitative detection of cytomegalovirus DNA

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.

Yes

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

Cytomegalovirus, PCR

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

CMV Detection by Real-Time PCR

Cytomegalovirus, PCR

LightCycler CMV

PCR (Polymerase Chain Reaction)

LCMV

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
CMVPS Specimen Source

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

Submit only 1 of the following specimens:

 

Specimen Type: Body fluid

Sources: Spinal, pleural, peritoneal, ascites, pericardial, amniotic, or ocular

Supplies: Sarstedt Aliquot Tube, 5mL (T914)

Container/Tube:

Preferred: Sterile, screwcap, 5-mL aliquot tube

Acceptable: Sterile container

Specimen Volume: 0.5 mL

Collection Instructions: Do not centrifuge.

 

Specimen Type: Respiratory fluid

Sources: Bronchial washing, bronchoalveolar lavage, nasopharyngeal aspirate or washing, sputum, or tracheal aspirate

Supplies: Sarstedt Aliquot Tube, 5mL

Container/Tube:

Preferred: Sterile, screwcap, 5-mL aliquot tube

Acceptable: Sterile container

Specimen Volume: 1.5 mL

Collection Instructions: Do not centrifuge.

 

Specimen Type: Genital swab

Sources: Cervix, vagina, urethra, anal/rectal, or other genital sources

Supplies:

-Culturette (BBL Culture Swab) (T092)

-M4-RT (T605)

Container/Tube: Multimicrobe media (M4-RT) and ESwabs

Collection Instructions: Place swab back into multimicrobe media (M4-RT, M4, or M5)

 

Specimen Type: Swab

Sources: Dermal, eye, nasal, saliva, or throat

Supplies:

-Culturette (BBL Culture Swab) (T092)

-M4-RT (T605)

Container/Tube: Multimicrobe media (M4-RT) and ESwabs

Collection Instructions: Place swab back into multimicrobe media (M4-RT, M4, or M5)

 

Specimen Type: Tissue

Sources: Brain, colon, kidney, liver, lung, etc.

Supplies: M4-RT (T605)

Container/Tube: Sterile container containing 1 mL to 2 mL of sterile saline or multimicrobe medium (M4-RT, M4, or M5)

Specimen Volume: Entire collection

Collection Instructions: Submit only fresh tissue in multimicrobe media (M4-RT) or a sterile container with 1 to 2 mL sterile saline

 

Specimen Type: Urine

Container/Tube: Sterile container

Specimen Volume: 1 mL

Collection Instructions: Collect a random urine specimen.

 

Specimen Type: Bone marrow

Container/Tube: Lavender top (EDTA)

Specimen Volume: 0.5 mL

Collection Instructions: Send bone marrow in original tube. Do not aliquot.

Forms

If not ordering electronically, complete, print, and send a Microbiology Test Request (T244) with the specimen.

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.

Ocular Fluid, Spinal Fluid, or Urine: 0.3 mL

Body Fluid (pleural, peritoneal, ascites, pericardial): See Specimen Required

Respiratory Specimens: 1 mL

Tissue: 2 x 2-mm biopsy

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

 
Calcium alginate-tipped swab
Wood swab
Transport swab containing gel
Feces
Paraffin blocks
Breast milk
Heat inactivated specimens 		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

 

This test is not intended for the monitoring of CMV disease progression.

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

Infection with cytomegalovirus (CMV) is a significant cause of morbidity and mortality in transplant recipients and other immunocompromised hosts. Specific neurologic syndromes associated with CMV infection include subacute radiculomyelopathy, peripheral neuropathy, and encephalitis.

 

CMV-associated central nervous system (CNS) disease occurs most commonly in immunocompromised patients. Histologic evidence of CMV infections in autopsy brain tissue was identified in 20% to 40% of AIDS patients. In 2 separate studies, CMV (DNA) was the most common herpesvirus (29/181, 16/49) detected from the cerebrospinal fluid of patients with AIDS. 

 

CNS infections with CMV can also occur in immunocompetent patients. CMV is a leading cause of congenital viral infections worldwide, and laboratory testing by real-time polymerase chain reaction is useful in the diagnosis of neonatal CMV disease.

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

Detection of cytomegalovirus (CMV) DNA in a specimen supports the clinical diagnosis of infection due to this virus.

 

Studies indicate that CMV DNA is not detected by polymerase chain reaction in cerebrospinal fluid from patients without central nervous system disease caused by this virus.

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

A negative result does not eliminate the possibility of cytomegalovirus (CMV) infection.

 

This assay is only to be used for patients with a clinical history and symptoms consistent with CMV infection and must be interpreted in the context of the clinical picture.

Supportive Data

The following validation data support the use of this assay for clinical testing.

 

Accuracy:

A total of 200 prospective clinical samples (respiratory [n=72], urine [n=67], spinal fluid [n=25], fresh tissue [n=18], amniotic fluid [n=10], and bone marrow [n=8]) were submitted to our reference laboratory for cytomegalovirus (CMV) real-time polymerase chain reaction (PCR) (Roche analyte specific reagents, Roche Diagnostics). Respiratory samples included bronchoalveolar lavage (BAL) fluid (n=25), bronchial washing (n=40), nasal swab (n=4), tracheal secretions (n=2), and throat swab (n=1). Each sample was tested by 6 real-time PCR assays, and the results were compared to consensus reference standard (4 of 6 results being in agreement). The performance of the US9 CMV real-time PCR (laboratory-developed test) is summarized in the Table:

 

Table. Performance of the US9 CMV real-time PCR assay following testing of prospective clinical samples (n=200)

 

US9 CMV PCR

Consensus result

Positive

Negative

Kappa

Sensitivity

Specificity

Positive

45

0

0.99

97.8 (87.6-99.9)

100 (97.1-100)

Negative

1

154

 

 

 

 

Analytical Sensitivity/Limit of Detection:

To evaluate the analytical sensitivity, whole virus control (Acrometrix, Life Technologies) at a starting concentration of 500,000 copies/mL was used to generate a dilution panel. In brief, samples were diluted 1:2 in tris-EDTA buffer to a final concentration of 8 copies/mL. Each member of the dilution panel was then tested in triplicate, with the limit of detection (LOD) being defined as the highest dilution at which all replicates tested positive. The LOD was determined to be 122 copies/mL.(1)

 

Analytical Specificity:

No PCR signal was obtained from extracts of 44 bacterial and viral isolates including Epstein-Barr virus, herpes simplex virus, varicella-zoster virus, human herpes virus (HHV) 6, HHV7, HHV8, and parvovirus.

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

1. Binnicker MJ, Espy M. Comparison of six real-time PCR assays for the qualitative detection of cytomegalovirus in clinical specimens. J Clin Microbiol. 2013:51(11):3749-3752

2. Petito CK, Cho ES, Lemann W, Navia BA, Price RW. Neuropathy of acquired immunodeficiency syndrome (AIDS): an autopsy review. J Neuropathol Exp Neurol. 1986;45(6):635-646

3. Cinque P, Vago L, Dahl H, et al. Polymerase chain reaction on cerebrospinal fluid for diagnosis of virus-associated opportunistic diseases of the central nervous system in HIV-infected patients. AIDS. 1996;10(9):951-958

4. Broccolo F, Iulioano R, Careddu AM, et al. Detection of lymphotropic herpesvirus DNA by polymerase chain reaction in cerebrospinal fluid of AIDS patients with neurological disease. Acta Virol. 2000;44(3):137-143

5. Prosch S, Schielke E, Reip A, et al. Human cytomegalovirus (HCMV) encephalitis in an immunocompetent young person and diagnostic reliability of HCMV DNA PCR using cerebrospinal fluid of nonimmunosuppressed patients. J Clin Microbiol. 1998;36(12):3636-3640

6. Sia IG, Patel R. New strategies for prevention and therapy of cytomegalovirus infection and disease in solid-organ transplant recipients. Clin Microbiol Rev. 2000;13(1):83-121

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

Viral nucleic acid is extracted by the MagNA Pure automated instrument (Roche Applied Science) from clinical specimens. Primers directed to the target Us9 gene produce a 285-base pair amplicon. The LightCycler instrument amplifies and monitors by fluorescence the development of target nucleic acid sequences after the annealing step during polymerase chain reaction (PCR) cycling. This is an automated PCR system that can rapidly detect amplicon development through stringent air-controlled temperature cycling in capillary cuvettes. The detection of amplified products is based on the fluorescence resonance energy transfer (FRET) principle. For FRET product detection, a hybridization probe with a donor fluorophore, fluorescein, on the 3'-end is excited by an external light source and emits light that is absorbed by a second hybridization probe with an acceptor fluorophore, LC-Red 640, at the 5'-end. The acceptor fluorophore then emits a light of a different wavelength that can be measured with a signal that is proportional to the amount of specific PCR product. Melting curve analysis is performed following PCR amplification. Starting at 45 degrees C, the temperature in the thermal chamber is slowly raised to 80 degrees C and the fluorescence is measured at frequent intervals. Analysis of the PCR amplification and probe melting curves is accomplished through the use of LightCycler software.(Binnicker MJ, Espy M. Comparison of six real-time PCR assays for the qualitative detection of cytomegalovirus in clinical specimens. J Clin Microbiol. 2013:51[11]:3749-3752)

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 4 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

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 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
CMVPV Cytomegalovirus, PCR 5000-5
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.
CMVPS Specimen Source 31208-2
618969 Cytomegalovirus PCR 5000-5

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
Test Changes - Specimen Information 2023-11-13