MuirLab is pleased to announce the introduction of quantitative Hepatitis C Virus RNA testing by polymerase chain reaction (PCR).
Hepatitis C (HCV) is one of the most common—and significant—blood-borne infectious diseases in North America, and is a leading cause of chronic liver disease leading to liver failure and the need for transplantation. Although great strides have been made in the elimination of HCV from our nation's blood system, an estimated 1.6% of all Americans have been exposed to, or infected with, HCV. The majority of people infected with HCV go on to develop the chronic form of the disease, and approximately one quarter of those with chronic infection will develop complications. These complications include cirrhosis, liver failure, hepatocellular carcinoma, and death. As chronic HCV can be relatively asymptomatic, the only reliable method of measuring response to treatment is through serial measurements of the patient's viral load. Current treatment guidelines rely heavily on demonstrating a reduction of circulating HCV RNA levels at proscribed intervals during, and after completion of, treatment. Measuring these levels can help identify patients who are likely to have a sustained response to therapy versus those needed more prolonged treatment; conversely, unnecessary toxic side effects can be avoided in patients who are identified as resistant to therapy. As such, the AmpliPrep/ COBAS® TaqMan® HCV Test is offered as a valuable adjunct to help guide therapy of patients who have been previously diagnosed with HCV infection (initial diagnosis of HCV infection should rely on serologic testing as well as qualitative demonstration of the presence of HCV RNA).
The AmpliPrep/ COBAS® TaqMan® HCV Test is a nucleic acid amplification test that can be performed on serum or plasma. After automated specimen preparation to isolate RNA in the sample, a reverse transcription step using specific primers will result in conversion of the RNA in the sample to its complementary DNA (cDNA), along with known levels of a reference standard RNA. This cDNA is amplified using the polymerase chain reaction (PCR). Specific DNA probes can then be used to generate a signal, which is compared against the reference standard to allow calculation of an accurate HCV copy number. For more information please contact your MuirLab representative.