Is this a job for the IRB?  The case of the ELISA assay.
D015492:AIDS Serodiagnosis; D000163:Acquired Immunodeficiency Syndrome; D001782:Blood Donors; D003219:Confidentiality; D003237:Connecticut; D003933:Diagnosis; D017007:Duty to Warn; D017041:Ethics Committees; D028741:Ethics Committees, Clinical; D028744:Ethics Committees, Research; D035082:Federal Government; D006076:Government; D033161:Government Regulation; D006268:Health Facilities; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent; D008403:Mass Screening; D008499:Medical Records; D004364:Pharmaceutical Preparations; D011634:Public Health; D012107:Research Design; D012926:Social Control, Formal; D013219:State Government; D014486:United States Food and Drug Administration
Biomedical and Behavioral Research; Health Care and Public Health