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Test Code LABHCVQN Hepatitis C Virus RNA Detection and Quantitation by RT-PCR

Important Note

For detection and quantification of hepatitis C viral RNA in serum before, during, and after antiviral therapy for chronic hepatitis C.

 

Additional Codes

Test Name in EPIC

EPIC Test Code

Mnemonic
 HEPATITIS C VIRUS RNA DETECTION AND QUANTIFICATION
 		 LABHCVQN HCV QUANT

 

Test Alias

HCV

EH HCV

Useful For/Utility

Detection of acute hepatitis C virus (HCV) infection before the appearance of HCV antibodies in serum (ie, <2 months from exposure)

Detection and confirmation of chronic HCV infection

　Quantification of HCV RNA in serum of patients with chronic HCV infection (HCV antibody-positive)

　Monitoring disease progression in chronic HCV infection and response to antiviral therapy

　Determining cure and detection of relapse after completion of antiviral therapy

 

Methodology

Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR)

 

Clinical Information

Hepatitis C virus (HCV) is one of the major causes of liver disease. It was estimated that about 1.1% of the population are chronically infected with hepatitis C and approximately 700,000 people die each year from hepatitis C-related liver disease. HCV is a positive-strand RNA virus and transmitted primarily through intravenous drug use and through blood products. About 55 to 85% of HCV-infected individuals develop chronic hepatitis, with up to 30% of chronically infected individuals developing cirrhosis. In patients with cirrhosis, the incidence of hepatocellular carcinoma is 2 to 4% per year.

 

The diagnosis of HCV infection utilizes testing algorithms that rely on a sequential two-step process with the initial test assessing the presence/absence of HCV-specific antibody and followed by a confirmatory assay (eg, HCV nucleic acid test) for those with a positive HCV antibody result. A positive HCV antibody result indicates prior exposure to HCV but does not differentiate between active and non-active infections. In the presence of HCV antibodies, detection of HCV RNA confirms active HCV infection.

 

Quantitative measurement of HCV RNA levels in peripheral blood has been shown to be an essential parameter in the management of various anti-HCV therapies. With the advent of direct acting antiviral regimens, the treatments for HCV infection have been advanced dramatically. In the era of direct-acting antivirals (DAAs) HCV viral load measurements are used to monitor and determine successful HCV treatment, ie, sustained virological response (SVR). Guidelines from the AASLD define SVR as undetectable HCV RNA (determined with an assay that has a limit of detection of <25 IU/mL) after therapy. Guidelines from the AASLD suggest testing HCV RNA not only at baseline and at 12 weeks following completion of treatment, but also periodically during treatment (eg, 4 weeks)

 

Specimen Requirements

Serum gel (SST) preferred; plain serum (red top) accepted

Specimen volume:  1.5 mL (0.8 mL min) serum

1.5 mL (0.8 mL min)  serum required for testing

Specimens may be, but are not required, (Primary gel tube can be frozen after centrifugation however, it is not preferred) to be aliquoted to acceptable secondary tube. Freeze if specimen is aliquoted. 

Stable for 60 days frozen

 

 

Specimen Transport Temperature

Frozen (preferred) stabile 60 days

Refrigerated 72 hrs

Day(s) Test Set Up

Monday -Sunday

Performing Laboratory

SMD Clinical Laboratory

Test Classification and CPT Coding

87522

Reference Values

Reference Value:  Not Detected

This assay has a result range of 12 to 100,000,000 IU/mL (1.08 log to 8.00 log IU/mL) for quantification of hepatitis C virus (HCV) RNA in serum.

　A "Not Detected" result indicates that the HCV is absent in the patient's serum specimen.

<LLOQ

HCV RNA detected but not quantified

HCV RNA concentration is below the Lower Limit of Quantitation (LLOQ) of the assay (12 IU/mL).

Low level HCV viremia may indicate previous spontaneous or treatment-related resolution of HCV infection.

For HCV Diagnosis: Results must be interpreted within the context of all relevant clinical and laboratory findings.

For Viral Load Assessment: Routine clinical follow-up according to national HCV guidelines.

12 to <25 IU/mL

(1.08 to <1.40 Log IU/mL)

HCV RNA detected and quantified

HCV RNA concentration is within the linear range of the assay (≥12 IU/mL and <25 IU/mL).

Low level HCV viremia may indicate previous spontaneous or treatment-related resolution of HCV infection.

For HCV Diagnosis and Viral Load Assessment: Provide patient with appropriate counseling and link to care and treatment according to current national HCV treatment guidelines.

25 IU/mL to ≤ULOQ

(1.40 Log IU/mL to ≤ULOQ)

HCV RNA detected and quantified

HCV RNA concentration is within the linear range of the assay (≥25 IU/mL to ≤ULOQ).

Active HCV infection.

For HCV Diagnosis and Viral Load Assessment: Provide patient with appropriate counseling and link to care and treatment according to current national HCV treatment guidelines.

>ULOQ

HCV RNA detected

HCV RNA concentration is above the Upper Limit of Quantitation (ULOQ) of the assay.

Active HCV infection.

For HCV Diagnosis and Viral Load Assessment: Provide patient with appropriate counseling and link to care and treatment according to current national HCV treatment guidelines.