GENERAL INTRODUCTION AND REMARKS
One of the major focused goals of the International Consortium for Blood Safety (ICBS) is to advise developing countries about a sustainable supply of affordable, high quality, screening reagents. In order to achieve this goal, ICBS recognized the necessity of establishing the "Blood Screening'Test-kits Evaluation Center". The concept of a blood screening' test-kits evaluation center was adopted due to the fact that the majority of countries in the developing world do not have regulatory institutions capable of evaluating test kits for blood screening. ICBS and Paul-Ehrlich-Institut (PEI) in Langen, Germany agreed to collaborate in this regard. PEI agreed to foster the "ICBS Blood Screening & Test-Kits Evaluation Center" within its framework.
The causes of the problem of poor blood safety in the developing world are diverse and complex. Although many developing countries may claim to screen the donated blood, their screening may not necessarily cover all blood units throughout the country or be performed throughout the year. ICBS recognizes the fact that the lack of affordable and quality assured reagents for the screening of blood donations has largely contributed to the deplorable state of blood safety in countries with restricted economy. The Ministries of Health of many countries in the developing world have no specific budget allocated for blood safety. Due to the relatively high cost of blood screening tests for viral markers in general, much of the blood collected in most of the developing world is not screened. Besides, the sustainability of screening depends on the regular and uninterrupted availability of testing reagents, which is difficult to maintain in many developing countries due to the unaffordable cost of many screening test-kits. The unsatisfactory quality of some test-kits poses another grave problem. A number of local companies in developing countries have now begun manufacturing blood-screening reagents. The cost of these reagents is more affordable; however the important issue of the quality of these test-kits emerges.
ICBS is addressing these problems by the use of comprehensive test evaluation panels to identify high quality yet low cost test reagents. ICBS, through its Blood Screening Test-Kit Evaluation Center at the PEI, used the ICBS HCV Master Panel (established in September 2002) to evaluate commercially available HCV blood screening test-kits from numerous companies especially those manufactured in the developing world. In order to evaluate test-kits intended for end users, ICBS decided to buy the test-kits from the market through collaborators and agents in the countries (preferably developing countries) and not directly from the manufacturers.
The evaluation results and information, which have been made available on the ICBS Website, would permit national authorities in the developing world to make informed decisions regarding the choice of reagents to be used. In addition, it is important not to overlook the value of proper training of personnel, quality assurance, establishing quality systems in blood transfusion services and total quality management in general.
The evaluation results and relevant information are shown on this website in the following tables and files: CLICK HERE!