STANDARD Q HCV Ab Test is a rapid chromatographic immunoassay for the qualitative detection of specific antibodies to HCV present in human serum, plasma or whole blood. This test is for in vitro professional diagnostic use and intended as an aid to early diagnosis of HCV infection in patients with clinical symptoms of HCV infection. It provides only an initial screening test result. More specific alternative diagnosis methods should be performed in order to obtain the confirmation of HCV infection. STANDARD Q HCV Ab Test is intended to be used by trained healthcare or laboratory professionals or other health care workers who have received appropriate training. This product can be used by trained lay providers operating in point-of-care settings in resource-limited lower- and middle-income countries. This product is not intended for self-testing.