AEGiS-13IAC: Knowledge Protects: Performance analysis of the first complete set of site-of-care HIV-diagnosis.

13th International AIDS Conference

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

Knowledge Protects: Performance analysis of the first complete set of site-of-care HIV-diagnosis.

Int Conf AIDS 2000 Jul 9-14; 13:34 (abstract no.. LbPeA7011)

Repke H;;; GAIFAR, Hermannswerder 15, Potsdam, Germany. Fax: +49-331-298-3849, E-mail: repke@gaifar.com.

BACKGROUND: Reliable site-of-care HIV testing is an essential tool to slow down the spread of HIV, but is biased because of the lack of Western-Blot type confirmation and HIV1/2 differentiation tests.

METHODS: A new heat stable and sensitive detection system, the optimal catch avidity particles, was developed and used to create a new generation of rapid diagnostics. Epitope-combi antigens were constructed and expressed by molecular biology methods which combine the essential immunogenic epitopes of various HIV-genes and omit sites causing unspecific reactions. This approach resulted in the development of a 30 sec. screening assay (InstantScreen), a 6 min. HIV-1/HIV-2 differentiation assay (DoubleCheck) and a 6 min. HIV-1 Western Blot-type confirmation assay reflecting all major HIV gene families (Instant Confirm), collectively named the Knowledge Protects family of diagnostics.

RESULTS: 8700 patients were tested with InstantScreen and 100 % specificity and sensitivity was found and confirmed by at least 3 different assays (ELISA, PCR, WesternBlot). More than 300 "problem sera" (pregnant woman, hepatitis and other infectious diseases etc.) were tested without false positive results. More than 1000 patients were tested with InstantConfirm which was found to meet WHO, FDA and CDC requirements for Western-Blot type confirmation tests. DoubleCheck recognized more than 100 HIV-2 sera reliably, with more than 500 HIV-1 sera being detected in parallel with 100 % specificity and sensitivity.

CONCLUSIONS: For the first time, the Knowledge Protects test system tranfers the highest scientific standard of laboratory HIV-testing to a format which can be carried out without any equipment, infrastructure and specialized knowledge within minutes, thus eliminating the major bias against rapid HIV tests. Production and distribution approvals have been obtained. InstantScreen is used in large scale in SA and other African countries since a couple of months.

Keywords: AEGIS, HIV-2, HIV-1, HIV Antibodies, Blotting, Western, HIV Infections, Knowledge, Naphthalenes, HIV, AIDS Serodiagnosis, Enzyme-Linked Immunosorbent Assay, HIV Seropositivity, Sensitivity and Specificity, Research, HIV Core Protein p24, Immunoblotting, HIV Seroprevalence, Mass Screening, Immunoenzyme Techniques, protect, Human, Pregnancy, Female, Diagnosis, immunology, AIDS
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