First real-time HCV test receives CE mark
of the hepatitis C virus (HCV) has obtained regulatory approval for
commercial sale in Europe, signifying the first real-time test for
genotyping the HCV virus to receive the CE mark.
The sale of this kit throughout Europe gives European laboratories a new option for delivering reliable test results to patients quickly and efficiently.
Real-time PCR enables the production of large quantities of DNA from clinical samples in a short period of time, making it possible to detect low levels of a virus's genetic material.
The test is designed to identify HCV genotypes in patients suspected of infection. Quick identification allows the best course of treatment strategy to be carried out giving the patient the best chance of recovery.
HCV is a blood-borne viral disease, which can cause liver inflammation, fibrosis, cirrhosis and liver cancer.
HCV is spread by blood-to-blood contact with an infected person's blood. Many people with HCV infection have no symptoms and are unaware of the need to seek treatment.
The HCV infects an estimated 150-200m people worldwide. It is the leading cause of liver transplant in the US.
The HCV genotype is determined by means of a target specific amplification using reverse transcription-polymerase chain reaction (RT-PCR) to generate amplified product from the specific HCV RNA sequences.
The new RealTime HCV genotyping test delivers 32 results in less than 6 hours with a limit detection of 1,244 IU/ml, making it more sensitive than any other comparable commercially-available test.
This is the first RT-PCR genotyping assay approved for use with the advantages of enhanced turn-around time while minimising sample preparation and optimising ease of use in any size laboratory
"The hepatitis C virus has significant genetic variability throughout its entire genome," said Kathy Ordonez, President of Celera.
"The accurate identification of the HCV genotypes is an important factor in the management of HCV-infected individuals, and this new RealTime HCV Genotype test gives European laboratories an important new option for delivering highly reliable test results to patients quickly and efficiently," she added.
The new CE Mark approval expands the menu of tests available to European laboratories working in HCV infection, complementing the HCV quantitative viral load test currently available for use on the Abbott m2000 system.
A version of the HCV genotyping test adapted to the m2000 system is under development at Abbott.
