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For tissue banks, if the screening ELISA test is positive, is a confirmatory Western Blot required to be done and reportable?

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For tissue banks, if the screening ELISA test is positive, is a confirmatory Western Blot required to be done and reportable?

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Tissue banks are routinely conducting confirmatory Western Blot tests for living tissue donors and the positive Western Blot results are reportable. • Will participants in research studies or clinical trials be reported? If HIV testing is not being done for diagnostic purposes and is being done purely for research purposes in an IRB-approved research protocol, the HIV positive individual will not be reported. Individuals in research studies generally receive primary care; their primary care provider is required to report initial diagnosis of HIV and AIDS, and CD4<500 and positive viral load results done as part of primary care are reportable. • Why are patients who test HIV+, who are part of research vaccine trials, not being reported? Testing in research studies is technically non-diagnostic; such patients will be reported by their primary care providers. Vaccine recipients who may develop a positive HIV test but are not HIV infected, don't meet the requirements for reporting. • If a

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