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Clinical and Vaccine Immunology, February 2006, p. 302-303, Vol. 13, No. 2
1071-412X/06/$08.00+0     doi:10.1128/CVI.13.2.302-303.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

LETTER TO THE EDITOR

Different Positive Predictive Values of Commercially Available Human Immunodeficiency Virus Enzyme-Linked Immunosorbent Assays

	LETTER

Top Letter References

As part of a large HIV/STD Collaborative Prevention Trial sponsored by the U.S. National Institute of Mental Health (NIMH) and conducted by the NIMH Collaborative HIV/STD Prevention Trial Group, two population-based surveys were performed to evaluate the prevalence of HIV type 1 (HIV-1) infection and sexually transmitted diseases (STDs) in Lima, Peru, and in northern Peru in 2001 and 2003. While the 2001 study (survey 1) evaluated the general population, the 2003 study (survey 2) examined groups at higher risk for infection. Sera were screened by ELISA for antibodies to HIV-1 using Vironostika (bioMerieux, Inc., Durham, NC) and for antibodies to HIV-1/HIV-2 using Genscreen Plus Ag-Ab (Bio-Rad Laboratories, Marnes la Coquette, France) or Genetic Systems (Bio-Rad Laboratories, Hercules, CA). We confirmed ELISA-positive samples by HIV-1 Western blotting using New Lav Blot I (Bio-Rad France) or Genetic Systems (Bio-Rad USA). Due to several reported "indeterminate" results in survey 1 using New Lav Blot I, these samples were retested with Genetic Systems Western blot kit. ELISA-positive samples in survey 2 were confirmed by using only the Genetic Systems Western blot kit. Results from the Genetic Systems assay were used as the gold standard for determining PPVs in subsequent-calculations. The absence of reported cases of HIV-2 in Peru to date obviated the need for HIV-2-specific Western blot analysis. All samples were processed at the U.S. Naval Medical Research Center Detachment (Lima, Peru) by skilled technicians and were subject to rigorous quality control standards. All of the tests used were reported to have a specificity at or close to 99% in manufacturers' trials and in surveys of available tests published by the World Health Organization and the Centers for Disease Control and Prevention (1, 5). The PPV of the Vironostika assay, however, was significantly higher than the PPVs of the Genscreen test in survey 1 (100.0% versus 62.8% [P = 0.001]) and the Genetic Systems test in survey 2 (98.3% versus 85.2% [P = 0.009]) (Table 1). The PPV of the Vironostika assay was statistically comparable in the two surveys despite the lower prevalence of disease in the general population tested in survey 1 (P = 1.000).

(This work was originally presented at the Infectious Disease Society of America 2004 Annual Meeting, Boston, Mass., 30 September to 3 October 2004 [R. Castillo, R. Meza, S. Leon, J. Pajuelo, C. F. Caceres, J. D. Klausner, T. J. Coates, and F. R. Jones, Infect. Dis. Soc. Am. 2004 Annu. Meet. Program Abstr. Book, abstr. 826, 2004].)

	ACKNOWLEDGMENTS

 
This work was conducted as part of the NIMH Collaborative HIV/STD Prevention Trial Group project. This study was partially supported by LP-CRADA NM-04-1787 and work unit no. 847705 82000 25GB B0016.

The views expressed in this article are those of the authors and do not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, or the U.S. government.

The study protocol was approved by the Naval Medical Research Center Institutional Review Board (protocol NMRCD.2002.0007 [DoD 31555]) in compliance with all federal regulations governing the protection of human subjects.

	REFERENCES

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1. Centers for Disease Control and Prevention. 2003. Human immunodeficiency virus type 1 (HIV-1) rapid antibody testing. Report of results for the perfor- mance evaluation survey conducted during July 2003. Centers for Disease Control and Prevention Model Performance Evaluation Program. Centers for Disease Control and Prevention, Atlanta, Ga.
2. Gurtler, L. 1996. Difficulties and strategies of HIV diagnosis. Lancet 348:176-179.[CrossRef][Medline]
3. Holodiny, M., and M. P. Busch. 2003. Establishing the diagnosis of HIV infection, p. 3-20. In R. Dolin, H. Masur, and M. S. Saag (ed.), AIDS therapy. Elsevier Science, New York, N.Y.
4. Mylonakis, E., M. Paliou, M. Lally, T. P. Flanigan, and J. D. Rich. 2000. Laboratory testing for infection with the human immunodeficiency virus: established and novel approaches. Am. J. Med. 109:568-576.[CrossRef][Medline]
5. World Health Organization. 2004. HIV assays: operational characteristics (phase 1). Report 14. Simple/rapid tests. World Health Organization, Geneva, Switzerland.

This article has been cited by other articles:

• Guan, M. (2007). Frequency, Causes, and New Challenges of Indeterminate Results in Western Blot Confirmatory Testing for Antibodies to Human Immunodeficiency Virus. CVI 14: 649-659 [Full Text]  

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