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Test Code LAB5211 Cytomegalovirus (CMV) Molecular Detection, PCR, Varies

Important Note

Mayo code is CMVPV


Ordering Guidance


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

 

For lower respiratory specimens, order CMVLR / Cytomegalovirus (CMV) Molecular Detection, PCR, Lower Respiratory.



Necessary Information


1. Specimen source is required.

2. Source information must include main anatomical site of collection.



Specimen Required


Submit only 1 of the following specimens:

 

Specimen Type: Body fluid

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

Container/Tube:

Preferred: Sterile, screwcap, 5-mL aliquot tube

Acceptable: Sterile container

Specimen Volume: 0.5 mL

Collection Instructions: Do not centrifuge.

 

Specimen Type: Upper respiratory tract fluid

Sources: Nasopharyngeal aspirate or washing

Container/Tube:

Preferred: Sterile, screwcap, 5-mL aliquot tube

Acceptable: Sterile container

Specimen Volume: 1.5 mL

Collection Instructions: Do not centrifuge.

 

Specimen Type: Swab

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

Supplies:

-Culturette (BBL Culture Swab) (T092)

-M4-RT (T605)

Container/Tube: Multimicrobe media (M4-RT, M4, M5, Bartels, or Jiangsu) and ESwab or Culturette

Collection Instructions: Place swab back into multimicrobe media. 

 

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, M5, Bartels, or Jiangsu)

Specimen Volume: Entire collection

Collection Instructions: Submit only fresh tissue. 

 

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.

 


Useful For

Rapid qualitative detection of cytomegalovirus (CMV) DNA

 

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

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; Upper respiratory tract specimens: (Nasopharyngeal aspirate or washing): 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
Dry/flocked ESwab
Feces
Paraffin blocks
Breast milk
Heat-inactivated specimens
Reject

Reference Values

Negative

 

Reference values apply to all ages.

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.

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

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.