HRS §325-17
Rules for labs that test for HIV antibodies
Labs that test for HIV antibodies must follow specific testing steps. They must use FDA-approved tests, confirm positive results, and may have to send samples to the health department for extra checks. Breaking these rules can lead to penalties.
The statute, as written — Quality assurance standards for HIV antibody testing
(a) All laboratories performing screening and diagnostic tests for the presence of the antibody to HIV (human immunodeficiency virus) shall follow the recommended protocols as set forth below. Any test used for other than experimental purposes shall be approved by the Food and Drug Administration (FDA) of the United States for the use to which it is put. Any initially reactive FDA-approved screening test must be confirmed by a second test of the same type. Any specimen yielding reactive results to both FDA-approved screening tests must have a supplemental test performed such as a Western Blot, an IFA (immunofluorescence assay), or an antigen detection assay; provided that these standards may be superseded by rules adopted by the department pursuant to chapter 91. (b) Any laboratory performing tests for the presence of HIV may be required by the department of health to refer a sample from any specimen yielding a reactive result to the department for the purpose of supplemental testing of some or all samples for quality assurance purposes. The department may specify the information which shall accompany the specimen for epidemiological purposes; provided that the information shall not include any personal identifiers. (c) The penalty for any violation of this section shall be as specified in section 325-14.
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