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Molecular Testing in the Management of
Hepatitis C Virus Infection

Test Guide

Figure 1. Testing Algorithm

Table 1. Quantitative HCV RNA Assays

Test Code

(CPT Codea)

 Test Name

Reportable Range,
HCV RNA IU/mL

Specimen Requirements

Clinical Applications

10565X

(87522)

HEPTIMAX® 
HCV RNAb

5–50,000,000

3 mL (min. 1.0 mL) plasma in PPT-potassium EDTA (white-top tube).
Ship frozen.

Confirm infection; establish viral load at baseline; monitor viral load during therapy; determine duration of treatment; assess likelihood of non-response during treatment; assess likelihood of non-sustained response at end of treatment.

35645X

(87522)

Hepatitis C Viral RNA, Quantitative Real-Time PCRb

50–50,000,000

2 mL (min. 0.5 mL) plasma in PPT-potassium EDTA (white-top tube).
Ship frozen.

Establish viral load at baseline; monitor viral load during therapy; determine duration of treatment; assess likelihood of non-response during treatment.

10073X

(87522)

Hepatitis C Viral RNA, Quantitative TMAb

5–7,500

2 mL (min. 0.6 mL) plasma in PPT-potassium-EDTA (white-top tube).
Ship frozen.

Confirm infection; assess likelihood of non-sustained response at end of treatment.

29271X

(87522)

Hepatitis C Viral RNA, Quantitative bDNA

615–7,700,000

1 mL (min. 0.2 mL) plasma in potassium EDTA (white-top tube) or no-additive serum-separator tube.
Ship frozen.

Establish viral load at baseline; monitor viral load during therapy; determine duration of treatment; assess likelihood of non-response during treatment.

11348X

(87522)

Hepatitis C Viral RNA, Quantitative PCRb with Reflex to Genotype, LiPAb,c

50–50,000,000
(Reflex to genotype
if >300 IU/mL)

3 mL (min. 1.1 mL) plasma in PPT-potassium EDTA (white-top tube).
Ship frozen.

Establish viral load and genotype at baseline; determine duration of treatment and likelihood of response.
19702X
(87522)		 HEPTIMAX®
HCV RNAb with Reflex to Genotype, LiPAb,c		 5–50,000,000
(Reflex to genotype if  >300 IU/mL)		 3.2 mL (min. 1.6 mL) plasma in PPT-potassium EDTA (white-top tube).
Ship frozen.		 Establish viral load and genotype at baseline; determine duration of treatment and likelihood of response.
Table 2. Qualitative HCV RNA Assays

Test Code

(CPT Codea)

Test Name

Limit of Detection

(LOD), IU/mL

Specimen Requirements

Clinical Applications

37273X

(87521)

Hepatitis C Viral RNA, Qualitative TMA

10

2 mL (min. 0.6 mL) plasma in PPT-potassium EDTA (white-top tube).
Ship frozen.

Confirm presence of chronic HCV infection; differentiate between resolved and active infection.

34024X
(87521)

Hepatitis C Viral RNA, Qualitative PCR

50

2 mL (min. 0.6 mL) plasma in PPT-potassium EDTA (white-top tube).
Ship frozen.

Confirm presence of chronic HCV infection; differentiate between resolved and active infection.

Table 3. HCV Genotype Assay

Test Code

(CPT Codea)

Test Name

Limit of Detection

Specimen Requirements

Clinical Applications

37811X

(87902)

Hepatitis C Viral RNA Genotype, LiPAb

Minimum viral load: 300 IU/mL

2 mL (min. 0.6 mL) plasma in PPT potassium EDTA (white-top tube).
Ship frozen.

Assess length of treatment required and likelihood of response (used at baseline).

a The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.

b This test was developed and its performance characteristics have been determined by Quest Diagnostics Nichols Institute. It has not been cleared or approved by the US Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

c Reflex tests are performed at an additional charge and are associated with an additional CPT code.

References

  1. Department of Veterans Affairs Hepatitis C Resource Center; Yee HS, Currie SL, Darling JM, et al. Management and treatment of hepatitis C viral infection: recommendations from the Department of Veterans Affairs Hepatitis C Resource Center program and the National Hepatitis C Program office. Am J Gastroenterol. 2006;101:2360-2378.

  2. Dienstag JL, McHutchison JG. American Gastroenterological Association technical review on the management of hepatitis C. Gastroenterology. 2006;130:231-264.

  3. Strader DB, Wright T, Thomas DL, et al; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C. Hepatology. 2004;39:1147-1171. Erratum in: Hepatology. 2004;40:269.

  4. Scott JD, Gretch DR. Molecular diagnostics of hepatitis C virus infection: a systematic review. JAMA. 2007;297:724-732.

  5. Sarrazin C, Teuber G, Kokka R, et al. Detection of residual hepatitis C virus RNA by transcription-mediated amplification in patients with complete virologic response according to polymerase chain reaction-based assays. Hepatology. 2000;32:818-823.

  6. Mangia A, Santoro R, Minerva N, et al. Peginterferon alfa-2b and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2005;352:2609-2617.

  7. Sarrazin C, Hendricks DA, Sedarati F, et al. Assessment, by transcription-mediated amplification, of virologic response in patients with chronic hepatitis C virus treated with peginterferon alpha-2a. J Clin Microbiol. 2001;39:2850-2855.

  8. Alter MJ, Kuhnert WL, Finelli L; Centers for Disease Control and Prevention. Guidelines for laboratory testing and result reporting of antibody to hepatitis C virus. Centers for Disease Control and Prevention. MMWR Recomm Rep. 2003;52(RR-3):1-16.

  9. Kadam JS, Gonzalez SA, Ahmed F, et al. Prognostic significance of hepatitis C virus RNA detection by transcription-mediated amplification with negative polymerase chain reaction during therapy with peginterferon alpha and ribavirin. Dig Dis Sci. 2007 Apr 4; [Epub ahead of print].

 

Polymerase chain reaction (PCR) is performed pursuant to a license agreement with Roche Molecular Systems, Inc.

 
Content reviewed 10/2008
 
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