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Test Code LAB4900 Adenovirus DNA Detection by PCR, Qualitative

Methodology

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

Whole blood specimens that are positive by the qualitative adenovirus assay will be automatically sent for quantitative adenovirus whole blood testing.
 

Infection with adenovirus can manifest in a variety of ways, ranging from fever with upper respiratory symptomatology to diarrhea1.  One of the more severe manifestations of adenovirus infection is disseminated disease.  This can occur in patients with underlying immunosuppression, particularly suppression in T-cell immunity, and can be fatal.  Treatment is available for patients with disseminated adenovirus infection, though has significant side effects2.  Close monitoring of adenovirus viral load is essential to balance treatment efficacy and toxicity.  Patients with initial qualitative positivity for adenovirus in whole blood specimens require subsequent quantitative testing as soon as possible to prevent treatment delays.

Performing Laboratory

Barnes-Jewish Hospital Molecular Infectious Disease Laboratory

Specimen Requirements

 

Acceptable Specimens:

Whole blood (Lavender-top/EDTA tube), Bronchoalveolar lavage, Bronchial wash, tracheal aspirate, or Nasopharyngeal Swab in viral transport medium
 

 

Collection Procedure:

Blood

1. Draw blood into tube. Avoid hemolysis.

2. Maintain sterility and forward promptly at ambient temperature only. 

 

Bronchial Alveolar Lavage (BAL), Bronchial Washes, or Tracheal Aspirate

1. Aseptically collect at least 1.0 mL of BAL, bronchial wash specimen, or tracheal aspirate.

2. Place specimen in a labeled, screw-capped, sterile container. 

3. Maintain sterility and forward promptly.

Note:

1. Specimen source is required

 

Nasopharyngeal Swab

1. Obtain a vial of universal/viral transport medium (UTM) with collection swab

2. Collect nasopharyngeal specimen

3. Place the swab in labeled UTM vial, break off shaft of swab and discard excess piece of

shaft. To prevent leaking, make sure the swabs do not interfere with tightening cap on vial.

Note:

1. Specimen source is required

 

 

 

   

Specimen Transport Temperature

Blood-Ambient/Refrigerate /Frozen OK

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

Swabs- Ambient/Refrigerate/Frozen OK

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

Reference Values

Negative

Day(s) Test Set Up

Monday-Sunday

 

Turnaround Time:
STAT: not available
Routine: 1-3 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, lower respiratory specimens, and NP swabs.

Assay Limit of Detection:

Lower Respiratory Samples:  2,000 copies/mL

Blood:  20,000 copies/mL

NP swabs: 2,000 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

 

CPT Code:

87798, qualitative

87799, quantitative - used only for patients that reflex to quantitative testing.  See Methodology section for details.

Additional Information

For BJH Laboratory Use Only

Minimum Volume: 
Blood (Lavender-top / EDTA tube):  2.0 mL

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

 

Laboratory Processing Instructions:
BJH Microbiology will forward to the performing laboratory.

Literature References

1Heim A and Hayden R T.  Adenovirus.  Manuel of Clinical Microbiology 12th Edition, 2019;106:1831-1846

2Hiwarkar P, Amrolia P, Sivaprakasam P, et al. Brincidofovir is highly efficacious in controlling adenoviremia in pediatric recipients of hematopoietic cell transplant. Blood. 2017;129(14):2033-2037. doi:10.1182/blood-2016-11-749721