MAXIM BIOMEDICAL, INC. HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) CAMBRIDGE BIOTECH HIV-1 WESTERN BLOT KIT For Detection of Antibodies to HIV-1 (Cat. No. 98002) NAME AND INTENDED USE The Cambridge Biotech HIV-1 Western Blot Kit is an in vitro qualitative assay for the detection and identification of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1), contained in human serum or plasma. It is intended for use with persons of unknown risks as an additional specific test on human serum or plasma specimens found to be repeatedly reactive using a screening procedure, such as an Enzyme-Linked Immunosorbent Assay (ELISA). It is also intended for use as an additional specific test to be used with serum or plasma specimens obtained from subjects found to be reactive using rapid HIV-1 tests. SUMMARY AND EXPLANATION OF TEST The Enzyme-Linked Immunosorbent Blot Technique (“Western Blot”)1,2 has been used to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1), recognized as the etiologic agent of the Acquired Immunodeficiency Syndrome (AIDS).2,3 The combination of electrophoretic separation of complex mixtures of antigens with the highly sensitive immunoblotting technique has been useful in characterizing the antigenic profile of HIV-1 and describing the immune response to this virus in exposed or infected persons. The Cambridge Biotech HIV-1 Western Blot Kit, when used as directed in this insert, will detect antibodies to HIV-1 when present in human serum or plasma. The position of bands on the nitrocellulose strips allows this antibody reactivity to be associated with specific viral antigens. Persons demonstrating antibodies to HIV-1 should be referred for medical evaluation, which may include testing by other techniques. A clinical diagnosis of AIDS can be made only if a person meets the case definition of AIDS established by the Centers for Disease Control.