Korean J Lab Med.  2006 Feb;26(1):39-44. 10.3343/kjlm.2006.26.1.39.

Evaluation of Abbott Fourth Generation HIV Antigen and Antibody Assays

• Kang HJ
• Yoo KH
• Kim HS
• Cho HC

• KMID: 2143196
• DOI: http://doi.org/10.3343/kjlm.2006.26.1.39

Abstract

BACKGROUND: In order to reduce the diagnostic window period between the time of human immunodeficiency virus (HIV) infection and serological diagnosis, new fourth generation screening assays which detect HIV p24 antigen and specific antibody simultaneously have been developed. In this study, we evaluated the performance of a new fourth generation assay.
METHODS
We compared a new fourth generation assay, Architect HIV Ag/Ab combo, with another fourth generation assay AxSYM HIV Ag/Ab combo and a third generation assay, AxSYM HIV 1/2 gO for their performance. The assays were evaluated using 3 HIV seroconversion panels, 305 sera of healthy subjects and 100 sera of patients with HBsAg or anti-HCV antibodies. Within-run and total coefficient variations of the three screening assays were analyzed for the evaluation of precision.
RESULTS
Architect HIV Ag/Ab combo shortened the window period by 8.7+/-2.1 days relative to AxSYM HIV 1/2 gO and 2.0+/-2.0 days relative to AxSYM HIV Ag/Ab combo in seroconversion panels. Architect HIV Ag/Ab combo presented the best performance in precision among the three reagents; total CV for positive control was 3.6%, 9.6% and 4.6% for Architect HIV Ag/Ab combo, AxSYM HIV Ag/Ab combo and AxSYM HIV 1/2 gO, respectively. Specificities of three assays were not different in this study.
CONCLUSIONS
HIV Ag/Ab combined assays reduced the diagnostic window as compared to the third generation screening assays, enabling an earlier diagnosis of HIV infection. A new fourth generation assay, Architect HIV Ag/Ab combo presents a better performance than AxSYM HIV Ag/Ab combo, showing improved seroconversion sensitivity and precision.

Keyword

HIV; Combined antigen/antibody test; Diagnosis

MeSH Terms

Diagnosis
Hepatitis B Surface Antigens
Hepatitis C Antibodies
HIV Core Protein p24
HIV Infections
HIV Seropositivity
HIV*
Humans
Indicators and Reagents
Mass Screening
HIV Core Protein p24
Hepatitis B Surface Antigens
Hepatitis C Antibodies
Indicators and Reagents

Reference

References

1. Joint United Nations Programme on HIV/AIDS and World Health Organization. AIDS Epidemic Update. December 2004.Geneva: UNAIDS;2004.

2. Zaaijer HL, v Exel-Oehlers P, Kraaijeveld T, Altena E, Lelie PN. Early detection of antibodies to HIV-1 by third-generation assays. Lancet. 1992; 340:770–2.

3. Bachmann P, Beyer J, Brust S, Engelhardt W, Gurtler LG, Habermehl KO, et al. Multicentre study for diagnostic evaluation of an assay for simultaneous detection of antibodies to HIV-1, HIV-2 and HIV-1 subtype 0 (HIV-0). Infection. 1995; 23:322–33.

4. Gurtler L, Muhlbacher A, Michl U, Hofmann H, Paggi GG, Bossi V, et al. Reduction of the diagnostic window with a new combined p24 antigen and human immunodeficiency virus antibody screening assay. J Virol Methods. 1998; 75:27–38.

5. Weber B, Fall EH, Berger A, Doerr HW. Reduction of diagnostic window by new fourth-generation human immunodeficiency virus screening assays. J Clin Microbiol. 1998; 36:2235–39.

6. Ly TD, Laperche S, Courouce AM. Early detection of human immunodeficiency virus infection using third- and fourth-generation screening assays. Eur J Clin Microbiol Infect Dis. 2001; 20:104–10.

7. Ly TD, Laperche S, Brennan C, Vallari A, Ebel A, Hunt J, et al. Evaluation of the sensitivity and specificity of six HIV combined p24 antigen and antibody assays. J Virol Methods. 2004; 122:185–94.

8. National Committee for Clinical Laboratory Standards. Evaluation of precision performance of clinical chemistry devices. Approved guideline. Document EP5-A.Wayne, Pa: National Committee for Clinical Laboratory Standards;1999.

9. Brust S, Duttmann H, Feldner J, Gurtler L, Thorstensson R, Simon F. Shortening of the diagnostic window with a new combined HIV p24 antigen and anti-HIV-1/2/O screening test. J Virol Methods. 2000; 90:153–65.

10. Ly TD, Edlinger C, Vabret A. Contribution of combined detection assays of p24 antigen and anti-human immunodeficiency virus (HIV) antibodies in diagnosis of primary HIV infection by routine testing. J Clin Microbiol. 2000; 38:2459–61.

11. Yeom J, Ryu S, Kang HJ, Cho K, Jang Y, Park J. Evaluation of usefulness of HIV Ag-Ab combination assay using LG HIV Ag-Ab Plus. Korean J Blood Transfusion. 2004; 15:203–12.

12. Sickinger E, Stieler M, Kaufman B, Kapprell HP, West D, Sandridge A, et al. Multicenter evaluation of a new, automated enzyme-linked immunoassay for detection of human immunodeficiency virus-specific antibodies and antigen. J Clin Microbiol. 2004; 42:21–9.

13. Andersson S, Asjo B, Jenum PA, Manner I, Njolstad G, Ragnhildstveit E, et al. Relevance of a combined HIV antigen/antibody assay to detect early HIV infection in a low prevalence population: case reports. Clin Lab. 2004; 50:409–13.

14. McElborough D. Importance of using an HIV Ag/Ab combined assay in a UK population at high risk of acquiring HIV infection. Commun Dis Public Health. 2004; 7:312–4.

15. Soldan K, Davison K, Dow B. Estimates of the frequency of HBV, HCV, and HIV infectious donations entering the blood supply in the United Kingdom, 1996 to 2003. Euro Surveill. 2005; 10:17–9.