Adenovirus Quantitative Real-time PCR

Test Code: 7500

Some specimen types for this assay are reported as qualitative results; please see our Specimen Information section below for more information.

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Clinical and Procedure
Clinical Utility

Adenovirus is an important cause of morbidity and mortality in the transplant setting, causing pneumonia, hemorrhagic cystitis, hepatitis, encephalitis, pancreatitis, enteritis, and disseminated disease with the mortality rate reaching 60% in some especially high risk situations such as pediatric hematopoietic stem cell transplantation. Since proper management is dependent upon early diagnosis, quantitative adenovirus DNA PCR is useful for detecting the virus, tracking the course of infection, and monitoring response to treatment. Treatment of adenovirus in immunocompromised patients presents challenges, including drug toxicity, delayed onset of disease after discontinuing therapy, and emergence of mutations that may affect the ability of diagnostic assays to detect them efficiently.

About Adenovirus

Severe morbidity and mortality due to adenovirus infection affect both hematopoietic stem cell transplant and solid organ transplant recipients.1  Common illnesses due to adenovirus infection include hemorrhagic cystitis/nephritis, pneumonitis, hepatitis, liver failure, and gastroenteritis, particularly during the acute post-transplant period prior to engraftment.  Symptoms of adenovirus infection vary widely, depending on the organ involved.  Adenovirus nephritis is associated with acute renal failure in 90% of infected patients.2 Also, adenovirus infection is associated with graft-versus-host-disease (GvHD) and allograft failures.1 

Procedure

Extraction of adenovirus DNA from specimen followed by amplification and detection of known adenovirus strains using real-time, quantitative PCR. An internal control is added to ensure the extraction was performed correctly and the PCR reaction was not inhibited. Sequence polymorphisms in the assay target region can cause impaired primer or probe binding, which may result in significant under-quantification or a false negative result. To eliminate this possibility, Viracor’s Adenovirus qPCR assay targets two regions within the pathogen genome, utilizing unique primer and probe sets for each target site. When a polymorphism occurs in one assay target, the additional sets of primers and probes for the alternate target region will still detect and accurately quantify the pathogen, and thus reduces the likelihood of under-qualification or a false negative result. This test was developed and its performance characteristics determined by Viracor Eurofins. It has not been cleared or approved by the U.S. Food and Drug Administration.

Specificity

Detects all known serotypes in one assay. The primers and probes used in this assay are specific for known adenovirus strains based on similarity search algorithms. Additionally, no cross reactivity was detected when tested against BKV, CMV, EBV, HSV-1, HSV-2, HHV-6 variant A, HHV-6 variant B, HHV-7, HHV-8, JCV, Parvovirus B19, SV-40, and VZV.

Turnaround Time

Same day (within 8 - 12 hours from receipt of specimen), Monday through Saturday, with the exception of Tissue and Bone Marrow specimens. Tissue and Bone Marrow specimens are expected to report within 18-24 hours from receipt of specimen, Monday-Saturday.

Specimen Information
Specimen Type Test Code CPT Code NY Approved Volume Assay Range Special Instructions
plasma 7501 87799 Yes

2 mL (min. 0.5 mL)

190 copies/mL to 1x1010 copies/mL
  • Collect 4-5 mL whole blood in EDTA or ACD tube.
  • Avoid using gel separator tubes; samples collected in gel separator tubes have increased rate of PCR inhibition.
  • Centrifuge and transfer 2 mL plasma to sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
urine 7502 87799 Yes

2 mL (min. 0.5 mL)

152 copies/mL to 1x1010 copies/mL
  • Collect in a sterile urinalysis container then transfer to sterile, screw top tube for shipment
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
CSF 7503 87799 Yes

2 mL (min. 0.5 mL)

109 copies/mL to 1x1010 copies/mL
  • Collect in a sterile, screw top tube.
  • Store frozen and ship on dry ice for overnight delivery.
bone marrow 7504 87799 Yes

2 mL (min. 0.2 mL)

589 copies/mL to 1x1010 copies/mL
  • Collect in EDTA tube.
  • Do not centrifuge.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
Fresh Frozen Tissue [Quant] 7505 87799 Yes 5 mg fresh tissue (approximately ½ of a pencil eraser size) 13 copies/mL to 1x1010 copies/mL
  • Place fresh tissue in a sterile, screw top container.
  • Do not add water, saline or other fluid media to container.
  • Store frozen and ship on dry ice for overnight delivery.
  • Formalin fixed, paraffin embedded tissue will not be accepted.
Fresh Frozen Tissue [Qual] 7506 87798 Yes 5 mg fresh tissue (approximately ½ of a pencil eraser size) Detected/Not Detected
  • Place fresh tissue in a sterile, screw top container.
  • The preferred handling is to not add water, saline or other fluid media to the tissue container; however, fluid media filled containers will be accepted for qualitative results.
  • Store frozen and ship on dry ice for overnight delivery.
  • Formalin fixed, paraffin embedded tissue will not be accepted.
fecal [Quant] 7538 87799 Yes

Size of pea, or 2 mL liquid stool

1500 copies/g to 1.25E+11 copies/g
  • Collect and place in a sterile, screw top tube.
  • Store frozen and ship on dry ice for overnight delivery.
fecal [Qual] 7508 87798 Yes

Size of pea, or 2 mL liquid stool

Detected/Not Detected
  • Collect and place in a sterile, screw top tube.
  • Store frozen and ship on dry ice for overnight delivery.
BAL 7509 87799 Yes

2 mL (min. 0.5 mL)

38 copies/mL to 1x1010 copies/mL
  • Collect in a sterile, screw top tube.
  • Ship at ambient or frozen temperature.
  • Specimens shipped ambient temperature must be received within 96 hours of collection.
serum 7510 87799 Yes

2 mL (min. 0.5 mL)

190 copies/mL to 1x1010 copies/mL
  • Collect 4-5 mL whole blood in red top tube.
  • Avoid using gel separator tubes; samples collected in gel separator tubes have increased rate of PCR inhibition.
  • Centrifuge and transfer 2 mL serum to sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
pleural fluid 7511 87799 Yes

2 mL (min. 0.5 mL)

157 copies/mL to 1x1010 copies/mL
  • Collect in a sterile, screw top tube.
  • Store frozen and ship on dry ice for overnight delivery.
pericardial fluid 7512 87799 Yes

2 mL (min. 0.5 mL)

157 copies/mL to 1x1010 copies/mL
  • Collect in a sterile, screw top tube.
  • Store frozen and ship on dry ice for overnight delivery.
nasal wash 7513 87799 Yes

2 mL (min. 0.5 mL)

54 copies/mL to 1x1010 copies/mL
  • Collect in a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
trach asp 7519 87799 Yes

2 mL (min. 0.5 mL)

38 copies/mL to 1x1010 copies/mL
  • Collect in a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
throat gargle 7523 87799 Yes

2 mL (min. 0.5 mL)

54 copies/mL to 1x1010 copies/mL
  • Collect 2 mL in sterile, screw top tube
  • Centrifuge and transfer 2 mL serum to sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
NP aspirate 7524 87799 Yes

2 mL (min. 0.5 mL)

54 copies/mL to 1x1010 copies/mL
  • Collect in a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
NP swab 7525 87798 Yes

2 mL

Detected/Not Detected
  • Place sterile swab placed in 2 mL sterile saline, M4, or viral transport media in a sterile, screw top tube.
  • Do not use calcium alginate swab or wood shafted swab.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
bronch wash 7526 87799 Yes

2 mL (min. 0.5 mL)

38 copies/mL to 1x1010 copies/mL
  • Collect in a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
nasal swab 7530 87798 Yes

2 mL

Detected/Not Detected
  • Place sterile swab placed in 2 mL sterile saline, M4, or viral transport media in a sterile, screw top tube.
  • Do not use calcium alginate swab or wood shafted swab.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
nasal asp 7531 87799 Yes

2 mL (min. 0.5 mL)

54 copies/mL to 1x1010 copies/mL
  • Collect in a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
NP wash 7547 87799 Yes

2 mL (min. 0.5 mL)

54 copies/mL to 1x1010 copies/mL
  • Collect in a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
trach wash 7548 87799 Yes

2 mL (min. 0.5 mL)

38 copies/mL to 1x1010 copies/mL
  • Collect in a sterile, screw top tube.
  • Can be shipped at ambient or frozen temperature Monday through Friday.
  • Specimens shipped at ambient temperature must be received within 96 hrs. of collection.
Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor Eurofins test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor Eurofins, 18000 W 99th St. Ste, #10, Lenexa, KS 66219

Causes for Rejection

Wood shafted swab, calcium alginate swab, specimens received in trap containers, grossly hemolyzed plasma/serum specimens, specimens beyond their acceptable length of time from collection as listed in the specimen handling, or specimen types other than those listed.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above.

The CPT codes provided are based on Eurofins Viracor's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Eurofins Viracor assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

References

1 Echavarria M. Adenoviruses in immunocompromised hosts. Clin Microbial Rev. Oct 2008;21(4):704-15.

2 Robin M, Marque-Juillet S, Scieux C, et al. Disseminated adenovirus infections after allogeneic hematopoietic stem cell transplantation: incidence, risk factors and outcome. Haematologica. Sep 2007;92(9):1254-7.

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