REF:

C2201 (Strip)

C2202 (Cassette)

INTENDED PURPOSE:

NOVAtest® HCV Total Antibody Serum Test is an immunoassay that uses double-antigen sandwich method for qualitative detection of anti-HCV antibody in human serum and plasma specimens. It’s used for aid to diagnosis HCV infection. This device is performed manually.

INTENDED USER:

Performance of the test is limited to laboratory professional use.

SUMMARY:

Hepatitis C virus (HCV) is a single-stranded RNA virus which encodes at least 10 viral proteins. An estimated 71 million people worldwide are living with chronic hepatitis C infection. Africa has the highest WHO estimated regional HCV prevalence (5.3%). Egypt has the highest prevalence (17.5%) of HCV in the world.

HCV transmission is most commonly associated with direct percutaneous exposure to blood, via blood transfusions, healthcare-related injections, and injecting drug use. Key high-risk populations include people who inject drugs, men who have sex with men, and prisoners.

The development of serological has revolutionized the diagnosis of HCV. The current WHO recommendation is to use at least two serological tests based on different technical principles. The HCV Total Antibody Serum Test is an instant antibody test which detects anti-HCV antibody within 20 minutes without any instrument requirements.