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Test Code Soft ZG103 (Mayo CMVPV) Cytomegalovirus (CMV) Molecular Detection, PCR, Varies

Additional Codes

Mayo Code CMVPV
Epic Name Cytomegalovirus by PCR
Epic Code LAB20022
Soft Name Cytomegalovirus by PCR

 


Ordering Guidance


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



Necessary Information


Specimen source is required.



Specimen Required


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.


Secondary ID

618968

Useful For

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

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

Reporting Name

Cytomegalovirus, PCR

Specimen Type

Varies

Specimen Minimum Volume

Ocular Fluid, Spinal Fluid, or Urine: 0.3 mL
Body Fluid (pleural, peritoneal, ascites, pericardial): See Specimen Required
Respiratory Specimens: 1 mL
Tissue: 2 × 2-mm biopsy

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Refrigerated (preferred) 7 days
  Frozen  7 days

Reject Due To

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

Clinical Information

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

Negative

Reference values apply to all ages.

Interpretation

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

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

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

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° C, the temperature in the thermal chamber is slowly raised to 80° 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)

Day(s) Performed

Monday through Sunday

Report Available

Same day/1 to 4 days

Specimen Retention Time

7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

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

87496

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CMVPV Cytomegalovirus, PCR 5000-5

 

Result ID Test Result Name Result LOINC Value
CMVPS Specimen Source 31208-2
618969 Cytomegalovirus PCR 5000-5

Forms

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