INFO: HEPTIMAX® - HCV RNA test sensitive to 10 IU/mL or less - TMA method

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HEPTIMAX® Test Highlight Clinical Use Predict response to antiviral therapy Differentiate lack of therapeutic response from partial therapeutic response Demonstrate resolution of

infection Clinical Background This HCV RNA test measures the level of hepatitis C virus (HCV) circulating in blood. It is able to measure very low levels of circulating HCV. Although this level does not correlate with severity of disease, it does correlate with the likelihood of response to antiviral therapy. Patients with a low baseline HCV RNA level are more likely to achieve eradication of the virus with treatment. During or

after therapy, rising or sustained HCV RNA levels indicate a lack of therapeutic response. A partial response is indicated by a drop in viral level of at least one-third of a log. In HCV type 1 infections, lack of a 2-log decrease after 12 weeks of treatment may predict treatment failure. At the end of treatment and afterwards, an undetectable level suggests a favorable therapeutic outcome. When demonstrating resolution of the infection, an HCV RNA test such as HEPTIMAX that is sensitive to 10 IU/mL or less should be used. Method The HEPTIMAX test begins with the HCV RNA real-time polymerase chain reaction

(PCR) method. If the HCV RNA level is below 50 IU/mL, then the sample is assayed again using the TMA method. The reportable range is 5 to 50,000,000 IU/mL. The following conversion factors are used when converting from copies/mL to IU/mL: PCR: Copies/mL = IU/mL x 2.7 TMA: Copies/mL = IU/mL x 5.2 CPT Code*: 87522 Interpretive Information Results ³5 IU/mL suggest continuing active HCV infection and may indicate insufficient therapeutic response. A rise in HCV RNA equal to or greater than three times the first result is significant for this assay and usually clinically significant. Decreasing levels are suggestive of therapeutic response when levels decrease by one-third of the first result or more. For more information, read Clinical Background, above. Specimen Requirements 3 mL frozen PPT-potassium EDTA (white-top tube) plasma; 1 mL minimumCentrifuge PPT tube within 2 hours of collection and freeze without transferring plasma to another tube. Ship frozen. Alternatively, collect in a red-top or lavender-top (EDTA) tube. Centrifuge, transfer serum or plasma to a plastic tube, and freeze within 2 hours of collection. Ship frozen. *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. This test was developed and its performance characteristics determined by Quest Diagnostics Nichols Institute. It has not been cleared or approved by the U.S. 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. Polymerase chain reaction (PCR) is performed pursuant to a license agreement with Roche Molecular Systems, Inc. Content reviewed 10/2005 http://www.questdiagnostics.com/hcp/intguide/jsp/showintguidepage.jsp?fn=TH_HEPTIMAX.htm

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On this test if your viral load is >50,000,000 the test drops a a zero. For example, My pre-treatment viral load was 109,000,000 yet Hepatimax reports it as 10,900,000.

Allan with 2 L's EVR YES!!!!!

INFO: HEPTIMAX® - HCV RNA test sensitive to 10 IU/mL or less - TMA method

HEPTIMAX®

Test Highlight

Clinical Use

Predict response to antiviral therapy

Differentiate lack of therapeutic response from partial therapeutic response

Demonstrate resolution of infection

Clinical Background

This HCV RNA test measures the level of hepatitis C virus (HCV) circulating in blood. It is able to measure very low levels of circulating HCV. Although this level does not correlate with severity of disease, it does correlate with the likelihood of response to antiviral therapy. Patients with a low baseline HCV RNA level are more likely to achieve eradication of the virus with treatment.

During or after therapy, rising or sustained HCV RNA levels indicate a lack of therapeutic response. A partial response is indicated by a drop in viral level of at least one-third of a log. In HCV type 1 infections, lack of a 2-log decrease after 12 weeks of treatment may predict treatment failure. At the end of treatment and afterwards, an undetectable level suggests a favorable therapeutic outcome. When demonstrating resolution of the infection, an HCV RNA test such as HEPTIMAX that is sensitive to 10 IU/mL or less should be used.

Method

The HEPTIMAX test begins with the HCV RNA real-time polymerase chain reaction (PCR) method. If the HCV RNA level is below 50 IU/mL, then the sample is assayed again using the TMA method. The reportable range is 5 to 50,000,000 IU/mL.

The following conversion factors are used when converting from copies/mL to IU/mL:

PCR: Copies/mL = IU/mL x 2.7

TMA: Copies/mL = IU/mL x 5.2

CPT Code*: 87522

Interpretive Information

Results ³5 IU/mL suggest continuing active HCV infection and may indicate insufficient therapeutic response. A rise in HCV RNA equal to or greater than three times the first result is significant for this assay and usually clinically significant. Decreasing levels are suggestive of therapeutic response when levels decrease by one-third of the first result or more. For more information, read Clinical Background, above.

Specimen Requirements

3 mL frozen PPT-potassium EDTA (white-top tube) plasma; 1 mL minimumCentrifuge PPT tube within 2 hours of collection and freeze without transferring plasma to another tube. Ship frozen.

Alternatively, collect in a red-top or lavender-top (EDTA) tube. Centrifuge, transfer serum or plasma to a plastic tube, and freeze within 2 hours of collection. Ship frozen.

*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.

This test was developed and its performance characteristics determined by Quest Diagnostics Nichols Institute. It has not been cleared or approved by the U.S. 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.

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

Content reviewed 10/2005

http://www.questdiagnostics.com/hcp/intguide/jsp/showintguidepage.jsp?fn=TH_HEPTIMAX.htm