Section 697.100  Approved HIV Tests and Testing Procedures

a)         Any person, laboratory, blood bank, hospital or other entity that conducts laboratory tests to detect the evidence of infection with HIV shall use tests approved by the FDA.

b)         Testing for the presence of antibodies to the HIV virus shall consist of the following:

1)         For the conventional HIV test, every sample shall be tested with an approved screening test.  If the test is found to be reactive (according to the package insert or product circular), a second screening test, in duplicate, shall be conducted as soon as possible.  If the second screening test is also found to be reactive, then a supplemental test shall be conducted.  If the supplemental test is found to be reactive (according to the package insert or product circular), then the sample shall be considered to indicate the presence of antibodies to HIV or to be positive.

2)         For the rapid HIV test, every sample shall be tested with an approved HIV rapid antibody screening test.  If the test is found to be reactive (according to the package insert or product circular), it will be considered preliminary positive and a supplemental test shall be conducted.  Before the supplemental test, a second sample shall be obtained, if necessary, to ensure an adequate sample amount.  If the supplemental test is found to be reactive (according to the package insert or product circular), then the sample shall be considered to indicate the presence of antibodies to HIV or to be positive.

3)         For both the conventional and rapid HIV tests, if the supplemental test is found to be indeterminate, then the specimen should be tested with another supplemental test.  If the sample is found to be reactive (according to the package insert or product circular), then the sample shall be considered to indicate the presence of antibodies to HIV or to be positive.

4)         All phases of testing required by this Section shall be completed before HIV test results are released to the physician or other individuals authorized to receive the results as described and limited in Section 697.140, except that, as allowed under subsection (b)(6), reactive results from rapid HIV antibody tests may be released to individuals authorized to receive the results under the following circumstances:

A)        when immediate medical treatment is necessary to prevent further transmission of HIV to a newborn infant in labor, delivery and postpartum settings.  For the purposes of this subsection (b)(4), immediate medical treatment, for a newborn infant, means upon delivery or within 48 hours after the infant's birth.  (Section 10 of the Perinatal HIV Prevention Act [410 ILCS 335])  Treatment shall be conducted as provided by the guidelines of the U.S. Public Health Service for reducing perinatal HIV transmission in the United States (see Section 697.30);

B)        in instances of occupational exposure, as provided by Section 697.140(a)(8) and (9); or

C)        at the time of testing, or immediately thereafter, provided that the subject of the test or the subject's legally authorized representative has received counseling that includes the limitations of the test and the need for supplemental testing, as well as appropriate risk reduction measures and referrals, and that the individual has consented to a rapid HIV antibody test and to the receipt of preliminary result.

5)         Before testing is conducted under subsection (b)(4)(A), (B) or (C), the  subject of the test or the subject's legally authorized representative shall have been counseled and shall have provided specific written informed consent to be tested and to receive a preliminary test result in accordance with Sections 697.110 and 697.120, except in the case of a newborn infant as provided in the Perinatal HIV Prevention Act.

6)         In such cases as the exceptions described in subsections (b)(4)(A), (B) or (C), a preliminary test result may be released to persons specified in Section 697.140(a)(1), (2), (3), (8), or (9).

7)         Any release of preliminary positive results from rapid HIV antibody tests shall include a disclaimer that an HIV positive diagnosis has not been made and cannot be made without supplemental testing.

8)         Any subject or subject's legally authorized representative receiving test results will receive counseling that includes the limitations of the test, appropriate risk reduction measures, appropriate referrals, and, if the test result is reactive, information on partner notification programs prior to being informed of the results.

(Source:  Amended at 30 Ill. Reg. 2373, effective February 3, 2006)