Test ID: LCMV
Cytomegalovirus (CMV), Molecular Detection, PCR
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Rapid 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
(PCR is utilized pursuant to a license agreement with Roche Molecular Systems, Inc.)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
CMV (Cytomegalovirus)
Cytomegalo Inclusion Disease (CMID)
Cytomegalovirus (CMV)
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Specimen source is required.
Submit only 1 of the following specimens:
Preferred:
Specimen Type: Body or ocular fluid
Container/Tube: Sterile container
Specimen Volume: 0.5 mL
Specimen Stability Information: Refrigerated (preferred) 7 days/Frozen 7 days
Specimen Type: Respiratory
Sources: Bronchial washing, bronchoalveolar lavage, nasopharyngeal aspirate or washing, sputum, or tracheal aspirate
Container/Tube: Sterile container
Specimen Volume: 1.5 mL
Specimen Stability Information: Refrigerated 7 days
Specimen Type: Spinal fluid
Container/Tube: Sterile vial
Specimen Volume: 0.5 mL
Collection Instructions: Do not centrifuge.
Specimen Stability Information: Refrigerated (preferred) 7 days/Frozen 7 days
Additional Information:
1. The high sensitivity of amplification by PCR requires the specimen be processed in an environment in which contamination of the specimen by CMV DNA is not likely.
2. Instructions for aliquoting CSF for PCR testing:
-All aliquoting for PCR testing should be done under a hood that has been bleached before and after use.
-Aliquot only 1 patient at a time.
-Use sterile (individually wrapped) plastic transfer pipettes.
-If aliquoting into several tubes from 1 patient tube, dedicate the first tube to PCR testing. Cap immediately after transferring specimen.
-Always dedicate 1 tube to PCR testing.
Specimen Type: Swab
Sources:
Preferred: Dermal, genital, eye, or throat
Acceptable: Urethral
Container/Tube: Culture transport swab
Specimen Volume: Entire specimen
Collection Instructions: Place swab back into swab cylinder.
Specimen Stability Information: Refrigerated (preferred) 7 days/Frozen 7 days
Specimen Type: Tissue
Sources: Brain, colon, kidney, liver, lung, etc.
Container/Tube: Sterile container with 1 to 2 mL of sterile saline or multi-microbe medium (M5) (Supply T484)
Specimen Volume: Entire collection
Collection Instructions: Collect a fresh tissue specimen.
Specimen Stability Information: Refrigerated 7 days
Specimen Type: Urine
Container/Tube: Sterile container
Specimen Volume: 2 mL
Collection Instructions: Collect a random urine specimen.
Specimen Stability Information: Refrigerated (preferred) 7 days/Frozen 7 days
Acceptable:
Specimen Type: Amniotic fluid
Container/Tube: Amniotic fluid container
Specimen Volume: 0.5 mL
Specimen Stability Information: Refrigerated (preferred) 7 days/Frozen 7 days
Specimen Type: Bone marrow
Container/Tube: Sterile container or lavender top (EDTA)
Specimen Volume: 0.5 mL
Specimen Stability Information: Refrigerated 7 days
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | NA |
| Lipemia | NA |
| Icterus | NA |
| Other | Calcium alginate-tipped swab, wood swab, or transport swab containing gel |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Varies | Varies | 7 days |
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, as well as neonates. Infection may involve multiple organs including the brain, lung, liver, and gastrointestinal tract.
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.
Not applicable
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 PCR 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. This test should not be used to screen asymptomatic patients.
Supportive Data
The following validation data support the use of this assay for clinical testing.
Accuracy and Diagnostic Sensitivity and Specificity:
LightCycler PCR (primers and probes directed to UL54 fragment of cytomegalovirus; CMV) was compared with shell vial cell cultures for the detection of CMV from 155 urine specimens. 142 specimens had concordant results between the 2 methods. Twelve specimens were positive for CMV by LightCycler PCR only and were confirmed by another PCR assay as true positives. Only 1 specimen was detected by the shell vial assay and not the LightCycler PCR.
In addition, 328 plasma specimens were tested by both the real-time LightCycler PCR assay targeting UL54 and a real-time PCR assay targeting the Hind IIIX region. Both detected 30 positive specimens and 296 negative specimens. The 2 discordant specimens were negative by the UL54 assay and positive by the Hind IIIX assay. These 2 specimens were positive by the UL54 assay on repeat testing, providing 100% concordance.
Fifty cerebrospinal fluid (CSF) specimens were tested by both conventional PCR and by real-time LightCycler PCR. CMV DNA was detected in 10 specimens by both amplification methods, and 40 specimens were negative for CMV DNA by both techniques (100% concordance).
Supplemental Data (Spiking Studies):
To supplement the above data, 30 negative specimens of all types acceptable for testing with this assay (urine, CSF, body fluids, dermal, tissue, respiratory; 180 total specimens) were spiked with CMV DNA plasmid control at the limit of detection (10-20 targets/mcL). The 30 spiked specimens from each group were run in a blinded manner along with 30 negative (nonspiked) specimens; 93% to 100% of the spiked specimens were positive and 100% of the nonspiked specimens were negative.
Analytical Sensitivity/Limit of Detection (LoD):
The lower limit of detection in this assay is <1,000 targets/mL (whole virus in specimen matrix).
Analytical Specificity:
No PCR signal was obtained from extracts of 44 bacterial and viral isolates including Epstein-Barr virus (EBV), herpes simplex virus (HSV), varicella-zoster virus (VZV), human herpes virus-6 (HHV6), HHV7, HHV8, and parvovirus.
Precision:
Interassay precision was 100% and intraassay precision was 97%.
Reportable Range:
This is a qualitative assay and the results are reported as either negative or positive for targeted CMV DNA.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Compston LI, Sarkodie F, Owusu-Ofori S, et al: Prevalence of persistent and latent viruses in untreated patients infected with HIV-1 from Ghana, West Africa. J Med Virol 2009 Nov;81(11):1860-1868
2. Hudnall SD, Chen T, Allison P, et al: Herpesvirus prevalence and viral load in healthy blood donors by quantitative real-time polymerase chain reaction. Transfusion 2008;48(6):1180-1187
3. 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 June-August;44(3):137-143
4. 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 December;36(12):3636-3640
5. Sia IG, Patel R: New strategies for prevention and therapy of cytomegalovirus infection and disease in solid-organ transplant recipients. Clin Microbiol Rev 2000;13:83-121
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 UL54 gene produce a 291 base pair amplicon. The LightCycler instrument amplifies and monitors by fluorescence the development of target nucleic acid sequences after the annealing step during 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. (Espy MJ, Smith TF: Detection of cytomegalovirus [CMV] in clinical specimens by LightCycler PCR. Abstr Gen Meet Am Soc Microbiol 2000; May 21-25)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Saturday; varies
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
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 The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
87496
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| SRC66 | Specimen Source | 31208-2 |
| 81240 | Result | 5000-5 |
| 6173 | Special Information | 48767-8 |
| 6174 | Report Status | N/A |
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