Test Information

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Hepatitis C Virus (HCV) Quantitative Real-time RT-PCR

Test Code: 1200

Cpt Code:

87522 (x1)

Clinical Utility

Assessment of HCV-RNA levels in patients undergoing antiviral therapy provides important information for measuring treatment response, which may aid in response guided treatment. The package inserts for the recently FDA-approved protease inhibitor drugs, IncivekTM (telaprevir) and VictrelisTM (boceprevir), for the treatment of chronic HCV Genotype 1, recommend patients be monitored utilizing a quantitative Real-time RT-PCR assay with a limit of quantification (LOQ) of 25 IU/mL and a limit of detection (LOD) of 10-15 IU/mL.1,2 The Viracor-IBT HCV Quantitative, Real-time RT-PCR assay meets these HCV-RNA testing requirements with an LOQ of 24 IU/mL and a LOD of 12 IU/mL.

Procedure

Extraction of nucleic acid from specimen; reverse transcription of the target RNA to generate complementary DNA, and amplification of target complementary DNA. Detection of hepatitis C genotypes 1 through 6 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-IBT's 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 6 HCV genotypes. The primers and probes used in this assay are specific for HCV.

Causes For Rejection

Specimens beyond their acceptable length of time from collection as listed in the specimen handling or specimen types other than those listed.

Turnaround Time

Same day (within 8 to 12 hours of receiving specimen), Monday through Saturday

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-IBT test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor-IBT Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086

Specimen Information

1201 plasma

Assay Range: 24 IU/mL to 1.3 x 108 IU/mL. HCV RNA detected below 24 IU/mL will be reported as "Detected: <24 IU/mL". Reported in 2 formats: IU/mL and Log 10 IU/mL. Collect 4-5 mL whole blood in EDTA, ACD or PPT, centrifuge and transfer 2 mL plasma to a sterile, screw top tube (minimum volume 0.7 mL). If the specimen was collected in PPT, the entire tube can be shipped following centrifugation. If shipped ambient, separated plasma fraction must arrive within 24 hours of draw. If shipped frozen, specimen must arrive within 7 days.

1205 tissue [Qual]

(CPT Code: 87521 X 1) Assay Range: (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 to Viracor-IBT. Formalin fixed, paraffin embedded tissue will not be accepted.

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-IBT'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. Viracor-IBT 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.

References

1. IncivekTM package insert. Cambridge, MA: Vertex Pharmaceuticals Incorporated; 2011
2. VictrelisTM package insert. Whitehouse Station, NJ: Merck & CO., INC.; 2011
3. CDC: Division of Viral Hepatitis and National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention.
http://www.cdc.gov/hepatitis/C/cFAQ.htm
4. Poordad F, McCone J Jr, Bacon BR, Bruno S, Manns MP, Sulkowski MS, et al. Boceprevir for Untreated Chronic HCV Genotype 1 Infection. New Eng J Med. 2011 Mar 31;364(13):1195-206.
5. Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales FL Jr, et al. Peginterferon alfa-2b plus ribavirin for chronic hepatitis C virus infection. New Eng J Med. 2002 Sep 26;347(13):975-82.
6. Ferenci P, Fried MW, Shiffman ML, Smith CI, Marinos G, Goncales FL Jr, et al. Predicting sustained virological responses in chronic hepatitis C patients treated with peginterferon alfa-2a (40KD)/ribavirin. J Heptol. 2005 Sep;43(3):425-33.
7. David GL, Wong JB, McHutchison JG, Manns MP, Harvey J, Albrecht J. Early virologic response to treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C. Hepatology. 2003 Sep;38(3):645-52.

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