The cobas® HCV is a laboratory test used to measure the amount of hepatitis C virus (HCV) RNA (ribonucleic acid) in a patient’s blood. Viral RNA is genetic material from HCV.
Hepatitis C is a liver infection caused by HCV. Hepatitis C is transmitted when blood or another body fluid from a person infected with the Hepatitis C virus enters the body of someone who is not infected. This can happen through sharing needles, syringes, or other drug-injection equipment, from mother to baby at birth, and less commonly, through sexual contact. Approximately 75% – 85% of people who become infected with hepatitis C develop chronic infection. Chronic Hepatitis C can lead to serious health issues, like cirrhosis or liver cancer.
The results from the cobas® HCV must be interpreted within the context of all other relevant clinical and laboratory findings.
How does it work? A sample of a patient’s blood is obtained and sent to a clinical laboratory. Nucleic acid (RNA) is automatically separated from serum or EDTA plasma using the cobas® 6800 or 8800 Systems. Separated RNA is mixed with the assay reagents. The cobas® 6800/8800 Systems calculate the amount of HCV RNA in the patient’s blood based on the fluorescent signal measured by the analyzer during reverse transcription polymerase chain reaction (RT-PCR). Measurement of the amount of HCV RNA in the blood together with clinical presentation and other laboratory findings is used by physicians to determine if an individual is actively infected with HCV and to help determine an individual’s response to treatment.
When is it used? This test is used together with other laboratory results and clinical information to determine whether a person has active HCV infection and to evaluate the treatment of an individual infected with the hepatitis C virus.
When should it not be used? The cobas® HCV should not be used if it is not ordered by a physician. It should not be used to screen blood or blood products for transfusion.
Additional information (including warnings, precautions and adverse events): Summary of Safety and Effectiveness Data and labeling are available.
