AEGiS-13IAC: Serological testing algorithm for recent HIV seroconversion (STARHS)investigational new drug program for a testing strategy to detect early HIV-i infection.

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

Serological testing algorithm for recent HIV seroconversion (STARHS)investigational new drug program for a testing strategy to detect early HIV-i infection.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. MoOrA109)

Withum DG, Janssen RS, Mei J, Fridlund C, Parekh B, Kothe D, Bell C, Candal D, Satten G
D.G. Withum, US Centers for Disease Control and Prevention, Atlanta Georgia 30333, United States, Tel.: +404 639 20 93, Fax: +404 639 20 29, E-mail: dgw2@cdc.gov

Backgound: STARHS uses a less sensitive (LS) EIA (3A11 Abbott Laboratories, Inc.) to distinguish persons with recent HIV-1 infection. A 3A11-LS assay is non-reactive if a person has been recently infected (average within 129 days) or if reactive, suggests a long-standing HIV-1 infection (average > 129 days).

METHODS: The US Centers for Disease Control and Prevention (CDC) developed a standardized laboratory protocol, test reagents, reporting system, and quality assurance (QA) program for STARHS. CDC sponsored an Investigational New Drug (IND) program approved by the US Food and Drug Administration. The IND allowed STARHS use in certain research studies and permitted CDC to distribute standardized reagents (calibrator [CAL] and low positive control [LPC]) needed for optimal assay performance. Beginning in September 1999, CDC distributed a series (3) of blinded QA panels containing 8 specimens each, to 13 IND laboratories. Both recent and long-standing HIV-1 positive specimens were included in the panels. Participating laboratories conducted STARHS testing on QA panels and reported results to CDC.

RESULTS: As of January 2000, a total of 25 laboratories (12 non-US and 13 US) participate in the IND. Besides 16 in North America, laboratories are located in the continents of Africa (3), Asia (1), Australia (1), Europe (3), and South America (1). Due to training aspects and reagent availability, not all laboratories had yet begun STARHS. Results from QA testing from 13 laboratories (303 total tests) were 100% concurrent with expected classification (recent vs. long-standing). Median values for standardized reagents were: CAL = 0.36 (SD 0.09) and LPC = 0.13 (SD 0.04). Correlation of LPC and CAL was 0.84 (p > 0.0001).

CONCLUSIONS: Reproducibility of STARHS testing was high among participating laboratories. Variance of test data on CDC-IND reagents was low. Further research will assess STARHS reliability among geographically diverse laboratories, non-B clade HIV-1 subtypes, and specimens from persons on HAART.

Keywords: AEGIS, HIV Seropositivity, HIV-1, Serologic Tests, AIDS Serodiagnosis, Algorithms, Research Design, Centers for Disease Control and Prevention (U.S.), Laboratories, Infection, Quality Control, South America, Europe, Africa, North America, Australia, Asia
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