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Performance evaluation of the new fully automated human immunodeficiency virus antigen‐antibody combination assay designed for blood screening
Author(s) -
Sickinger Eva,
Jonas Gesa,
Yem Alex W.,
Goller Andreas,
Stieler Myriam,
Brennan Catherine,
Hausmann Michael,
Schochetman Gerald,
Devare Sushil G.,
Hunt Jeffery C.,
Kapprell HansPeter,
Bryant Jane D.
Publication year - 2008
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/j.1537-2995.2007.01583.x
Subject(s) - seroconversion , antigen , medicine , antibody , virology , serology , immunology , window period , population , environmental health
BACKGROUND: Before the introduction of human immunodeficiency virus (HIV) combination assays, serologic diagnosis of HIV infection was performed with assays that detected either antibodies or p24 antigen. Owing to the capability to detect the early appearance of p24 antigen, combination assays that are designed for simultaneous detection of antibodies and antigen can significantly reduce the diagnostic window. STUDY DESIGN AND METHODS: Specificity and sensitivity of a commercially available HIV antigen‐antibody combination assay (Abbott PRISM; assay is not licensed by the FDA for use in the United States) were evaluated in a multicenter study by testing volunteer blood donors, hospitalized patients, seroconversion panels, and p24 antigen and HIV antibody subtype panels. Performance data were compared to a commercially available HIV combination assay and the PRISM HIV O Plus assay. RESULTS: Apparent specificity of 99.95 percent was observed in the donor population for the PRISM HIV antigen‐antibody combination assay, and better seroconversion sensitivity was demonstrated compared with another combination assay and the PRISM HIV O Plus assay. Analytical HIV antigen detection sensitivity averaged 33 pg per mL on the Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS) panel. Furthermore, comparable antigen sensitivity was demonstrated for 32 HIV‐1 group M subtype and group O panels. The PRISM HIV combination assay detected all HIV‐1 group M and O and HIV‐2 antibody–positive specimens evaluated. CONCLUSIONS: The PRISM HIV antigen‐antibody combination assay demonstrated a significant reduction of the window period for diagnosis of HIV infection. The assay demonstrated enhanced specificity and sensitivity along with broad subtype detection. The assay performance represents the “state‐of‐the art” technology for serologic blood screening of HIV infection.