Adenovirus Quantitative Real-time PCR

Test Code: 7500

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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.

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. Viracor Eurofins' assay design includes multiple targets to account for viral mutations, which significantly reduces the chance of false negative results. This test has not been cleared or approved for diagnostic use 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.

Specimen Information

Specimen Type	Order Code	CPT Code	NY Approved	Volume	Assay Range	Special Instructions
BAL	7509	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.
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.
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.
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.
fecal	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.
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.
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 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.
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.
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.
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. Ship Monday through Friday. Specimens shipped at ambient temperature must be received less than 48 hours from collection. Specimens greater than 48 hours from draw will be accepted if they have been stored frozen and shipped on dry ice overnight.
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. 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.
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. Ship Monday through Friday. Specimens shipped at ambient temperature must be received less than 48 hours from collection. Specimens greater than 48 hours from draw will be accepted if they have been stored frozen and shipped on dry ice overnight.
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. 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.
throat gargle	7523	87799	Yes	2 mL (min. 0.5 mL)	54 copies/mL to 1x10¹⁰ copies/mL	Collect 4-5 mL whole blood in red 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.
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.
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.
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.
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.
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.

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, 1001 NW Technology Dr, Lee's Summit, MO 64086

Causes for Rejection

Wood shafted swab, calcium alginate swab, specimens received in trap containers, 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 Viracor Eurofins' 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. Viracor Eurofins assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

PCR tests are performed pursuant to a license agreement with Roche Molecular Systems, Inc.