Detection of Hepatitis C Antibody With At-Home Collection Kits Using an Innovative Laboratory Algorithm

Hepatitis C virus infection (HCV) is a leading cause of morbidity and mortality. Most of the 4 million persons infected with HCV are unaware of their infection, and the United States has only recently begun to alert the general public to this health threat. The authors investigated a self-collection device used with an innovative laboratory algorithm (“STR”) and a telemedicine call center to test patients’ dried blood spots (DBS) for HCV antibodies, and counsel them according to their result. A total of 1,286 subjects were enrolled in this Institutional Review Board-approved study at nine United States sites in 1998. Subjects followed test kit instructions to self-collect their own DBS using a sterile lancet, used the telephone the call center to speak with a healthcare counselor, shipped their DBS to a CLIA-certified laboratory, and call for results. Following subject self-collection, phlebotomists drew DBS and venous samples from the subjects for use in sample adequacy and test accuracy respectively. Laboratory personnel were blinded to subject identity and to sample link.