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

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.

Evaluation of a prototype Trypanosoma cruzi antibody assay with recombinant antigens on a fully automated chemiluminescence analyzer for blood donor screening.

BACKGROUND: Chagas disease is caused by Trypanosoma cruzi, a protozoan parasite that can be transmitted by transfusion. The diagnosis of chronic T. cruzi infection is generally made by detecting specific antibodies that bind to parasite antigens. The aim of this study was to assess the sensitivity and specificity of a new serologic assay for antibodies to T. cruzi on a fully automated analyzer (PRISM, Abbott Laboratories). STUDY DESIGN AND METHODS: A prototype chemiluminescent immunoassay based on chimeric recombinant antigens and run on the automated PRISM system was developed for detecting antibodies to T. cruzi in human serum and plasma. Assay specificity was evaluated by testing samples from random blood donors and from a diverse group of specimens from persons with diseases or conditions often associated with false-positive reactions in T. cruzi assays. Sensitivity was determined by testing 377 geographically diverse T. cruzi antibody-positive specimens. RESULTS: Six of 7911 samples (0.08%) from random donors were repeatedly reactive in the prototype PRISM Chagas assay. One of these was reactive in three other tests, including the radioimmune precipitation assay and was presumed to be a true positive. Hence, the specificity was 99.94 percent (7905/7910) in the negative donor group studied. All 377 T. cruzi antibody-positive specimens were positive in the prototype assay and thus the sensitivity was 100 percent. CONCLUSION: The results obtained to date, in terms of sensitivity as well as specificity, strongly suggest that the PRISM Chagas assay should function well as a tool for screening blood for serologic evidence of T. cruzi infection.