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Test Code LAB4902 Cytomegalovirus (CMV) Detection (Qualitative)

Performing Laboratory

Barnes-Jewish Hospital Molecular Infectious Disease Laboratory – Bronchoalveolar lavage, Bronchial wash, tracheal aspirate, sputum, CSF, Urine, Tissue, saliva

Mayo Clinical Laboratory – Bone marrow, Amniotic fluid, Pericardial fluid, Peritoneal dialysis fluid, Peritoneal fluid, Pleural fluid

Test forwarded to Mayo by BJH Microbiology laboratory

Methodology

Polymerase Chain Reaction (PCR) 

 

Specimen Requirements

Bronchoalveolar lavage, Bronchial wash, tracheal aspirate, sputum, CSF, Urine, Tissue, saliva, Bone marrow, Amniotic fluid, Pericardial fluid, Peritoneal dialysis fluid, Peritoneal fluid, Pleural fluid
 

Collection Procedure:

 Bronchial Alveolar Lavage (BAL), Bronchial Washing, Sputum, or Tracheal Aspirate

  1. Aseptically collect at least 1.0 mL of BAL, bronchial wash specimen, sputum, or tracheal aspirate.
  2. Place specimen in a labeled, screw-capped, sterile container. 
  3. Maintain sterility and forward promptly.
  4. If transport is delayed, refrigerate specimen.

Note:  Specimen source is required

 

CSF

  1. Aseptically collect ≥1 mL of CSF.
  2. Place in a leak-proof screw-capped, sterile container.
  3. Maintain sterility and forward promptly.
  4. If transport is delayed, refrigerate specimen.

For BJH Patients: Laboratory medicine resident review and approval is required for CSF specimen requests.

 

Urine

  1. Aseptically collect > 1 mL of specimen.
  2. Place in a leak-proof screw-capped, sterile container.
  3. Maintain sterility and forward promptly.
  4. If transport is delayed, refrigerate specimen.

 

Tissue

  1. Aseptically collect ≥1 g of tissue.
  2. Place in a leak-proof screw-capped, sterile container.
  3. Maintain sterility and forward promptly.
  4. If transport is delayed, refrigerate specimen.

Note 1: Tissue can also be submitted in sterile UTM.

Note 2: Specimen source is required.

 

Neonatal saliva (Oral Swabs)

  1. Obtain a vial of universal/viral transport media (UTM/VTM) with collection side.
  2. Aseptically swab the inside of the neonate's mouth.
  3. Place swab in labeled UTM/VTM vial, break off shaft of swab and discard excess piece of shaft. To prevent leaking, make sure the swab does not interfere with the tightening of cap on vial.
  4. Maintain sterility and forward promptly.
  5. If transport is delayed, refrigerate specimen.

Note: Saliva testing outside of the neonatal population is unreliable and not of clinical utility.  

 

Bone Marrow

  1. Aseptically collect at least 0.5 mL of bone marrow in a lavendar top EDTA tube.
  2. Maintain sterility and forward promptly.
  3. If transport is delayed, refrigerate specimen.

 

Body fluid

  1. Aseptically collect at least 0.5 mL of fluid in sterile, leak proof, screw cap container
  2. Maintain sterility and forward promptly
  3. If transport is delayed, refrigerate specimen

Day(s) Test Set Up

Monday through Sunday

 

Turnaround Time:
STAT: not available

Routine: 1-2 days (BJH MID)

                2-5 days (Mayo)

Test Classification and CPT Coding

Test Classification:

The BJH Molecular Infectious Disease  assay utilizes ASR’s (analyte specific reagents) and is not FDA cleared.  Thetest was developed and its performance evaluated by the Barnes Jewish Molecular Infectious Disease Laboratory for performance on whole blood, CSF, lower respiratory, tissue, and saliva.

 

The Mayo test was developed and performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. The test has not been cleared or approved by the US Food and Drug Administration.

 

Assay Limit of Detection:

Lower Respiratory Samples:  500 copies/mL

Urine:  500 copies/mL

CSF: 100 copies/mL

Tissue:  100 copies/mL

Saliva: 500 copies/mL

Bone marrow: 122 copies/mL

Body fluid: 122 copies/mL

 

Limitations:

  1. The detection of viral nucleic acid is dependent upon proper sample collection, transport, handling and storage. Failure to observe proper procedures in any one of these steps can lead to incorrect results.
  2. False-negative results may occur if the viruses are present at a level that is below the analytical sensitivity of the assay or if the virus has genomic mutations, insertions, deletions, or rearrangements or if performed very early in the course of illness.
  3. Most adults have been exposed to CMV at some point during their lifetime and can transiently have detectable virus from different sample types with or without symptomatology.  Positive results should be interpreted in the appropriate clinical context.
  4. Saliva testing is unreliable in patient populations other than neonatal.

 

CPT Code:

87496

Reference Values

Negative

Specimen Transport Temperature

Ambient/Refrigerate/Frozen OK for all sample types

Refrigerated specimens must be tested within 7 days
Frozen specimens must be tested within 30 days

Additional Information

For BJH Laboratory Use Only

Minimum Volume:

Bronchial Alveolar Lavage (BAL), Bronchial Washes, or Tracheal Aspirate: 0.5 mL

CSF: 0.5 mL

Urine: 1.0 mL

Tissue: 1.0 g

Bone marrow: 0.5 mL

Body fluid: 0.5 mL

 

Laboratory Processing Instructions:

BJH Microbiology will forward bone marrow and body fluid samples to the Mayo Clinic laboratory.