Knowledge Protects: The first diagnostics system for final HIV-diagnosis on the spot
(PRWEB) July 16, 2000
- URGENT-NEW CONCEPT OF SHIELDED TESTING PRESENTED BY GERMAN COMPANY GAIFAR
AT AIDS 2000 CONFERENCE IN DURBAN, SOUTH AFRICA
14.7.2000
Knowledge Protects: The first diagnostics system for final HIV-diagnosis on the spot
The Knowledge Protects system is on display at the GAIFAR-Sekunjalo company booth No.60, Hall1, of GAIFAR in the Exhibition Center. Sekunjalo Health Care, one of the
Largest black empowerment companies in the medical field in South Africa is the distributor of GAIFAR in South Africa.
On July 10th 2000, at the AIDS-conference in Durban, South Africa, the first rapid test system worldwide was launched, which allows performing HIV-diagnosis in developing countries, even under a palm tree, with the same precision and scientific standard as in laboratories in the western world.
For the first time, the major ethical bias against rapid testing in the field, the absence of state-of-the-art confirmation testing, is eliminated.
The system uses a very small drop of blood, which can be obtained safely and quickly obtained by tools included in the test kit. The Knowledge Protects system consists of either two or three tests. These are:
InstantScreen – an HIV-1/HI-2 screening assay which takes only 30 seconds
To perform and can therefore be used to test between up to 500 and 1000 people per day, if two nurses take blood and two persons conduct the test.
If the person is positive, InstantConfirm will be performed. This is a simple strip, which is inserted into the vial which contains the rests of the blood mixture used in the screening test (InstantScreen). After 2 minutes, the strip is transferred in a vial with the detector solution and
Develops within further 6 minutes automatically.
For the first time, a real confirmation test is provided which is identical
With the Western Blot. This method is used as confirmation test in the developed countries since 15 years and costs around 100 US $ and considerable expertise to be performed. InstantConfirm contains all major
HIV-proteins displayed as lines, the same format as in the laboratory-based Western Blot. Therefore, it answers the essential question, which needs to be answered for a real confirmation of an HIV-infection: Does the patient have also antibodies against other HIV-proteins not used in the screening
Assay? Only in this case, a false positive reaction can be excluded with
Certainty.
If the person comes from an area where HIV-2 occurs, a second test should be
Performed: DoubleCheck is addressing the question as to whether the person is infected with HIV-1 or HIV-2. In the absence of a realistic chance for therapy for many people in developing countries, this knowledge can be quite important for the counseling given, since HIV-2 infection is usually developing not as fast into AIDS as this is the case with HIV-1 infection.
Availability
InstantScreen is currently in use in large scale for HIV-testing in various African countries, including South Africa, where the test was awarded one part of the recent government tender for rapid HIV-tests. It is available in all countries where the regulatory requirements are met.
Clinical studies
Clinical studies with InstantScreen have been conducted involving more than
9000 patients. 100 % specificity and 100 % sensitivity were found, even in countries where other infectious diseases such as malaria, tuberculosis and hepatitis are prevalent. Such diseases have been found to cause false positive reactions in a number of laboratory tests.
It is planned to introduce the test, as well as all other members of the Knowledge Protects family, also in Europe and the US,
Immediately after FDA and European approvals which are scheduled for the next month.
DoubleCheck was also found to have 100 % sensitivity and specificity. While
InstantScreen allows detecting HIV antibodies in serum amounts as low as 50
Nanoliters, DoubleCheck is even more sensitive, since amounts as low as 2-5
Nanoliters can be detected. This sensitivity can be important in cases where
People are newly infected, thus having low concentrations of antibodies
Against HIV.
InstantConfirm was found to meet the criteria for a confirmation test of the
Major international health organizations and can therefore be considered a
Real alternative to laboratory based confirmation testing.
The results of some of the recent clinical studies conducted will be
Presented in the late breaker poster session on Thursday in Durban(Poster
LbPeA7011).
Price
The price of the test system will naturally depend on the infection rate of
The population to be tested. In other words, the system will become more
Expensive, if a high number of confirmation and differentiation tests
(InstantConfirm and DoubleCheck) is required. In general, however, it needs
To be noted that the price of confirmation testing has been prohibitive for
Applying the same standard of diagnostic safety to developing countries as
It is taken for granted in the developed world since more than a decade.
Therefore, the fact that the Knowledge Protects system will be offered for
Less than 10 percent of the price of laboratory based testing and
Confirmation, it will be well in the reach of the governments and private
Clinics or doctors in developing countries.
The Knowledge Protects concept: a new and thought provoking set of proposals
To contain the spread of HIV in Africa (see separate press release
14.7.2000)
In addition, the head of GAIFAR (Dr. Heinrich Repke) and Prof. E. Ayensu
Have developed the Knowledge Protects Concept, a new and thought-provoking
Way of containing the spread of HIV in Africa. This concept is outlined in
Essential elements in the attached colour booklet and will be published in
August in form of a book. Prof. Ayensu is the President of the Pan-African Union for
Science and Technology and Member of the Inspection Panel of the World Bank.
He lives in Ghana and has worked for many years as a director of the Smithonian Institution in Washington D. C. Some remarks on this concept have been made during the session “Public Policy: Implementation and Impact” on Tuesday, 11.7. in I. C.C. IV from 13.00 to 14.30, where Dr. Repke acted as a chairperson.
Inventor and producer of the Knowledge Protects family:
German-American Institute for Applied Biomedical Research GmbH, (GAIFAR)
Hermannswerder 15 und 16, Biotech-Campus, 14473 Potsdam, Germany
FAX: +49-331-2983849, phone +49-331-2983812
E-mail: repke@gaifar. com
Website: www. gaifar. com
The Institute is an interface company, i. e. dedicated to transforming basic
Science into new technologies and products. The scientists of GAIFAR have
Worked for three years to develop a completely new and heat stable detection
System of unparalleled sensitivity, the OCA-particles. In addition, the
Company has used the considerable expertise in molecular biology to develop novel epitope-combi antigens, which are used in the tests described above.
These proteins contain the “hot spots” of all HIV proteins from all major strains and have eliminated all those parts of these proteins, which are known to cause unspecific reactions.
GAIFAR has two other areas of activity, which are based upon the application
Of molecular biology methods to medicine.
Heinrich Repke, Ph. D., D. Sc. is the President and CEO of GAIFAR. He has
Spent more than 20 years in academic research and was holding senior faculty
Positions in Germany as well as in the US before assuming his current position. Much of the work of GAIFAR is based upon his scientific work in the past.
Availability of H. Repke for comments during the meeting via cellular phone:
+49-172-3108383.
Samir Yastas (GAIFAR Marketing/IR)can be reached at: +49-172-309-6964 and
Yastas@gaifar. com
Interviews (TV/RADIO/PRESS) are welcome at Stand 60 until 16h in Hall 1 of
The Durban Congress.
