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

Test Code: 1200
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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 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 HCV Quantitative, Real-time RT-PCR assay meets these HCV-RNA testing requirements with an LOQ of 12 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. RealTime HCV is a product of Abbott Laboratories. It is FDA approved for in vitro diagnostic use.

Specificity

Detects all 6 HCV genotypes. The primers and probes used in this assay are specific for HCV.

Same day (within 8 - 12 hours from receipt of specimen), Tuesday through Saturday.

Specimen Type Order Code CPT Code NY Approved Volume Assay Range Special Instructions
plasma 1201 87522 Yes

2 mL (min. 0.7 mL)

12 IU/mL to 1.0 x 108 IU/mL, HCV DNA detected below 10 IU/mL will be reported as "<10 IU/mL". Reported in 2 formats: IU/mL and Log10 IU/mL.
  • Collect 4-5 mL whole blood in EDTA, ACD or PPT.
  • Centrifuge within 6 hours of draw and transfer 2 mL plasma to a sterile, screw top tube.
  • If the specimen was collected in PPT, the entire tube can be shipped frozen following centrifugation.
  • If shipped ambient, separated plasma fraction must arrive within 24 hours of draw.
serum 1210 87522 Yes

2 mL (min. 0.7 mL)

12 IU/mL to 1.0 x 108 IU/mL, HCV DNA detected below 10 IU/mL will be reported as "<10 IU/mL". Reported in 2 formats: IU/mL and Log10 IU/mL.
  • Collect 4-5 mL whole blood in red-top or SST.
  • Centrifuge within 6 hours of draw and transfer 2 mL serum to a sterile, screw top tube.
  • If the specimen was collected in SST, the entire tube can be shipped frozen following centrifugation.
  • If shipped ambient, separated serum fraction must arrive within 24 hours of draw.
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

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

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.

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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