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.


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.
Sickinger
Eva
E
Abbott GmbH & Co. KG, Wiesbaden, Germany. eva.sickinger@abbott.com
Jonas
Gesa
G
Yem
Alex W
AW
Goller
Andreas
A
Stieler
Myriam
M
Brennan
Catherine
C
Hausmann
Michael
M
Schochetman
Gerald
G
Devare
Sushil G
SG
Hunt
Jeffery C
JC
Kapprell
Hans-Peter
HP
Bryant
Jane D
JD
D046148:Donor Selection / Q000379:methods*; D015483:HIV Antibodies / Q000097:blood*; D016655:HIV Core Protein p24 / Q000276:immunology*; D015658:HIV Infections / Q000097:blood* / Q000175:diagnosis / Q000821:virology; D006801:Humans; D007118:Immunoassay / Q000379:methods; D008954:Models, Biological; D015203:Reproducibility of Results
D015483:HIV Antibodies; D016655:HIV Core Protein p24