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Journal of Clinical Microbiology, January 2004, p. 21-29, Vol. 42, No. 1
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.1.21-29.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Multicenter Evaluation of a New, Automated Enzyme-Linked Immunoassay for Detection of Human Immunodeficiency Virus-Specific Antibodies and Antigen

Eva Sickinger,1 Myriam Stieler,1 Boris Kaufman,1 Hans-Peter Kapprell,1 Daniel West,2 Arnold Sandridge,2 Sushil Devare,2 Gerald Schochetman,2 J. C. Hunt,2* David Daghfal,2 and the AxSYM Clinical Study Group{dagger}

Abbott Diagnostika GmbH & Co. KG, Wiesbaden, Germany,1 Abbott Laboratories, Abbott Park, Illinois2

Received 11 April 2003/ Returned for modification 5 August 2003/ Accepted 17 September 2003

A collaborative multicenter study was conducted to evaluate the sensitivity, specificity, and precision of a three-step, fully automated, qualitative microparticle-based enzyme-linked immunoassay (AxSYM HIV Ag/Ab Combo; Abbott Laboratories), designed to simultaneously detect (i) antibodies against human immunodeficiency virus type 1 (HIV-1) and/or type 2 (HIV-2) and (ii) HIV p24 antigen. A significant reduction in the HIV seroconversion window was achieved by combining detection of HIV antibodies and antigen into a single assay format. For 22 selected, commercial HIV seroconversion panels, the mean time of detection with the combined-format HIV antigen-antibody assay was reduced by 6.15 days compared to that with a similar third-generation single-format HIV antibody assay. The quantitative sensitivity of the combination assay for the p24 antigen (17.5 pg/ml by use of the p24 quantitative panel VIH SFTS96') was nearly equivalent to that of single-format antigen tests. The combination assay demonstrated sensitive (100%) detection of anti-HIV immunoglobulin in specimens from individuals in CDC stages A, B, and C and from individuals infected with different HIV-1 group M subtypes, group O, or HIV-2. The apparent specificity for hospitalized patients (n = 1,938) was 99.90%. In a random population of 7,900 volunteer blood donors, the specificity (99.87%) was comparable to that of a third-generation single-format HIV antibody assay (99.92%) on the same donor specimens. In addition, the combination assay was robust to potential interfering specimens. The precision of the combination was high, with intra- and interrun variances of <=9.3% for each precision panel specimen or assay control and <=5.3% for the negative assay control.

* Corresponding author. Mailing address: Dept. 9NG, Bldg. AP 20, 100 Abbott Park Rd., Abbott Park, IL 60064-6015. Phone: (847) 937-3455. Fax: (847) 937-1401. E-mail: Jeffrey.Hunt{at}Abbott.com.

{dagger} Participants of the AxSYM Clinical Study Group are listed in Acknowledgments.

Journal of Clinical Microbiology, January 2004, p. 21-29, Vol. 42, No. 1
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.1.21-29.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.



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