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22. World Medical Association. The Declaration of Helsinki; 2000. www.wma.net/e/ethicsunit/pdf/chapter_4_decl_of_helsinki.pdf
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Global criteria defining a positive HIV Western
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blot
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AFR=Africa1 AUS=Australia2 FDA=US Food and Drug Administration3 RCX=US Red Cross3 CDC=US Centers for Disease Control3 CON=US Consortium for Retrovirus Serology Standardization3 GER=Germany UK=United Kingdom FRA=France MACS= US Multicenter AIDS Cohort Study 1987-1992. * Bands not in electrophoretic orderNOTESorder
NOTES:
I. “The Association of Public Health Laboratories now recommends that patients who have minimal positive results on the WB, eg p24 and gp160 only, or gp41 and gp160 only, be told that these patterns have been seen in persons who are not infected with HIV and that follow-up testing is required to determine actual infective status”.4II4
II. In February 1993 the US Food and Drug Administration relaxed their criteria in order to “reduce the number of HIV-1 seroindeterminate Western blot interpretations”, that is, to increase the number of HIV positive individuals.51. 5
WHO. (1990). Acquired Immunodeficiency Syndrome (AIDS). Proposed criteria for interpreting results from Western blot assays for HIV-1, HIV-2 and HTLV-I/HTLV-II. Weekly Epidemiological Record 65:281-298.
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Healy DS, Maskill WJ, Howard TS, et al. (1992). HIV-1 Western blot: development and assessment of testing to resolve indeterminate reactivity. AIDS 6:629-633.
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Lundberg GD. (1988). Serological Diagnosis of Human Immunodeficiency Virus Infection by Western blot Testing. Journal of the American Medical Association 260:674-679. (Data presented in this paper reveal that when the FDA criteria are used to interpret the HIV Western blot less than 50% of US AIDS patients are HIV positive whereas 10% of persons not at risk of AIDS are also positive).
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Mylonakis E, Paliou M, Greenbough TC, Flaningan TP, Letvin NL, Rich JD. Report of a false-positive HIV test result and the potential use of additional tests in establishing HIV serostatus. Archives of Internal Medicine 2000;160:2386-8.
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Keinman S, Busch MP, Hall L, et al. (1998). False-positive HIV-1 test results in a low -risk screening setting of voluntary blood donation. Journal of the American Medical Association 280:1080-1083.