MMWR: Guidelines for Laboratory Testing and Result Reporting of Antibody to Hepatitis C Virus

This report presents guidelines for identifying persons with hepatitis C virus (HCV) infection. It recommends that testing for anti-HCV should include the use of an antibody screening assay, and for screening test-positive results, a more specific supplemental assay. The guidelines expand recommendations for anti-HCV testing to include an option for reflex supplemental testing, based on screening-test-positive signal-to-cut-off ratios. Use of signal-to-cut-off ratios minimizes the amount of supplemental testing that needs to be performed while improving the reliability of reported test results. These guidelines were developed on the basis of available knowledge of CDC staff in consultation with representatives from the Food and Drug Administration and public health, hospital, and independent laboratories. Adoption of these guidelines by all public and private laboratories that perform in vitro diagnostic anti-HCV testing will improve the accuracy and utility of reported anti-HCV test results for counseling and medical evaluation of patients by health care professionals and for surveillance by public health departments.