Importance of quality assurance testing of malaria rapid diagnostic test in the case management of malaria

Prompt and rapid diagnosis of malaria has gained importance in health programmes in endemic countries, and recognition of the importance of early, correct treatment to the reduction in malaria morbidity and mortality. Blood-based diagnosis using lateral-flow immunochromatographic tests, commonly called rapid diagnostics tests (RDTs), offer great promise in extending rapid diagnosis to areas where traditional microscopy is not accessible. Large-scale operational use has raised questions about the accuracy of current RDT technology in tropical conditions. As utilization of RDTs has increased rapidly in the last few years, there is a clear and urgent need to address issues on quality performance and appropriateness of use, particularly in remote endemic areas. The need for Quality Assurance (QA) systems to maintain the quality of microscopy diagnosis of malaria is well established but the extent of implementation varies widely. Quality assurance process must become an integral part of RDT budgets, procurement and implementation plans. Responsibility for overseeing QA processes, extending from post purchase testing of RDTs to training and supervision of users and control of storage and transport, should be clearly defined and coordinated from a central level. A system of regional and referral laboratories, based on standard operating procedures would test RDTs after purchase and for the duration of shelf-life using quality control (QC) panels prepared from wild-type parasites. The use of positive control wells (PCW) containing recombinant antigens would assist in assuring the performance of RDTs in the field and this would assist in the parasite-base confirmation and in the case management of malaria. Quality assurance processes must be transparent, and good communication with manufacturers and end-users during QA development is necessary.Prompt and rapid diagnosis of malaria has gained importance in health programmes in endemic countries, and recognition of the importance of early, correct treatment to the reduction in malaria morbidity and mortality. Blood-based diagnosis using lateral-flow immunochromatographic tests, commonly called rapid diagnostics tests (RDTs), offer great promise in extending rapid diagnosis to areas where traditional microscopy is not accessible. Large-scale operational use has raised questions about the accuracy of current RDT technology in tropical conditions. As utilization of RDTs has increased rapidly in the last few years, there is a clear and urgent need to address issues on quality performance and appropriateness of use, particularly in remote endemic areas. The need for Quality Assurance (QA) systems to maintain the quality of microscopy diagnosis of malaria is well established but the extent of implementation varies widely. Quality assurance process must become an integral part of RDT budgets, procurement and implementation plans. Responsibility for overseeing QA processes, extending from post purchase testing of RDTs to training and supervision of users and control of storage and transport, should be clearly defined and coordinated from a central level. A system of regional and referral laboratories, based on standard operating procedures would test RDTs after purchase and for the duration of shelf-life using quality control (QC) panels prepared from wild-type parasites. The use of positive control wells (PCW) containing recombinant antigens would assist in assuring the performance of RDTs in the field and this would assist in the parasite-base confirmation and in the case management of malaria. Quality assurance processes must be transparent, and good communication with manufacturers and end-users during QA development is necessary.

Keywords:

Quality assurance , Quality control panels , Malaria , Rapid diagnostic tests