Performance evaluation of the new fully automated human immunodeficiency virus antigen-antibody combination assay designed for blood screening

Transfusion
Eva SickingerJane D Bryant

Abstract

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. 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. 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 ...Continue Reading

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Citations

Mar 15, 2012·Current HIV/AIDS Reports·Meagan O'Brien, Martin Markowitz
May 20, 2011·The New England Journal of Medicine·Myron S CohenBarton F Haynes
Mar 17, 2010·The Journal of Infectious Diseases·Marco L SchitoMichael P Busch
Jun 19, 2012·Medical Microbiology and Immunology·A MühlbacherG de Sousa
Jul 17, 2012·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Thoai Duong LySyria Laperche
Feb 9, 2011·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Eva Van BraeckelGeert Leroux-Roels
Jun 2, 2009·Journal of Virological Methods·Shon WorkmanTimothy C Granade
Jul 17, 2010·Transfusion·Ester C SabinoUNKNOWN NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II) and International Component
Sep 9, 2017·Current Infectious Disease Reports·Aurélia HennSébastien Gallien

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