18 Del. Admin. Code § 1209-4.0

Current through Register Vol. 28, No. 3, September 1, 2024

Section 1209-4.0 - Effective Date

This regulation shall become effective February 1, 1998.

(ATTACHMENT NO. 1)

Test Protocol As Established By The Delaware Department Of Public Health

A medically significant and sufficiently reliable test or series of tests for the presence of HIV, antigen or nonantigenic products of HIV or an antibody to HIV includes one of more of the following.

3 DE Reg. 288 (8/1/99)

a. A single specimen which is repeatedly reactive using any Food and Drug Administration (FDA) licensed enzyme immunoassay (EIA) HIV antibody test and confirmed positive using an FDA licensed HIV antibody confirmatory test (e.g., Western blot, immunofluorescence assay).

b. A single specimen which is repeatedly reactive using an FDA licensed HIV antigen test and an FDA licensed EIA HIV antibody test. Specimens which are repeatedly reactive to an FDA licensed HIV antigen test shall be confirmed through a neutraliza-tion assay. Specimens which are repeatedly reactive to an FDA licensed EIA HIV antibody test shall be tested with an FDA licensed HIV antibody confirmatory test.

c. A single specimen which is tested for the presence of HIV using a molecular amplification method for the detection of HIV nucleic acids (e.g., polymerase chain reaction, RNA viral load) consistent with the National Committee for Clinical Laboratory Standards.

d. A single specimen which is tested for the presence of HIV using viral culture methods.

18 Del. Admin. Code § 1209-4.0