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Test Code LAB4902 Cytomegalovirus (CMV) Detection (Qualitative)

Performing Laboratory

Barnes-Jewish Hospital Molecular Infectious Disease Laboratory

Methodology

Polymerase Chain Reaction (PCR) performed on the DiaSorin Liaison MDX.

 

Specimen Requirements

Acceptable Specimens:

Bronchoalveolar lavage, Bronchial wash, tracheal aspirate, sputum, CSF, Urine, Tissue, saliva
 

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.  

 

Day(s) Test Set Up

Monday through Sunday

 

Turnaround Time:
STAT: not available
Routine: 1-2 days, Final report available the day of testing

Test Classification and CPT Coding

Test Classification:

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

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

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

Bronchial Alveolar Lavage (BAL), Bronchial Washes, or Tracheal Aspirate - Ambient/Refrigerate/Frozen OK

CSF - Ambient/Refrigerate/Frozen OK

Urine - Ambient/Refrigerate/Frozen OK

Tissue - Ambient/Refrigerate/Frozen OK

Saliva - Ambient/Refrigerate/Frozen OK

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

 

Laboratory Processing Instructions:

BJH Microbiology will forward to the performing laboratory.