Hepatitis C virus is a common blood-borne pathogen that relies heavily on nucleic acid testing for confirmation of infection.
Nucleic acid tests are invaluable for the diagnosis of Hepatitis C virus infection.
The nucleic acid tests provide critical prognostic information for guiding treatment and measuring the response to antiviral therapy.
Dr John Scott and colleagues from Seattle reviewed the currently available molecular diagnostic tests for Hepatitis C virus.
|Hep C RNA negative tests are strong predictors of treatment success|
|Journal of the American Medical Association|
The research team evaluated the clinical applications of the molecular diagnostic tests, and how these tests shed light on the natural history of Hepatitis C.
The team searched MEDLINE from 1966 to 2006, and article reference lists.
In addition, the researchers searched national meeting abstracts for the diagnosis and applications of molecular diagnostic tests for Hepatitis C virus.
Studies were selected on the basis of clinical relevance.
Qualitative nucleic acid tests have low limits of detection, and are used for confirmation of Hepatitis C virus infection and for screening blood donations.
The team found that Hepatitis C virus genotype test results provide important prognostic information related to therapeutic response.
The researchers observed that the genotype test are routinely used for selecting treatment regimens.
Quantitative Hepatitis C virus RNA testing provides prognostic information regarding likelihood of treatment response.
The team noted that the quantitative tests play an important role in monitoring the antiviral response to treatment.
The researchers reported that sustained virological response is defined as testing negative for Hepatitis C virus RNA 6 months after cessation of therapy.
The team noted that recent studies suggest that the rate of response to therapy is also important.
Conversion to a Hepatitis C RNA negative test result after 4 weeks of therapy constitutes a rapid virological response.
The researchers found that a Hepatitis C RNA negative test result is a strong predictor of treatment success.
Patients who have not had an early virological response was defined as at least a 2-log decline in Hepatitis C virus RNA after 12 weeks of therapy.
The team noted that these patients are unlikely to respond with an additional 36 weeks of therapy, and should stop therapy.
Dr Scott's team concludes, “A sensitive nucleic acid test should be used to confirm all cases of acute or chronic Hepatitis C virus infection.”
“A genotype test and quantitative Hepatitis C virus RNA test should be performed on all patients prior to therapy to best assess probability of response.”
“The test aids in selection of appropriate therapeutic regimen.”
“Monitoring Hepatitis C virus RNA during treatment provides important information on likelihood of sustained virological response.”
“The same type of quantitative Hepatitis C virus RNA test should be used throughout a patient's treatment course.”