Report of a tuberculosis diagnostics workshop, Cleveland, Ohio, 27 July 1997
A tuberculosis diagnostics workshop was held on 27 July 1997 in Cleveland Ohio in order to develop product performance guidelines for new tuberculosis diagnostics intended for use in low-income countries. The guidelines were developed in part to assist the diagnostics industry in their efforts to develop useful new products. Participants in the meeting included some 65 basic and clinical scientists, representatives from industry, representatives from U.S. and European regulatory agencies, experts from mycobacteriology laboratories, and representatives from low/middle income countries with direct experience in tuberculosis control programmes.
Performance guidelines were prepared for four categories of products:
- Tests to replace AFB microscopy in the diagnosis of smear positive pulmonary tuberculosis,
- Tests to improve the differential diagnosis of AFB smear negative tuberculosis,
- Tests to improve/simplify antibiotic susceptibility testing,
- Tests for recent and/or latent infection for use in prevalence surveys.
The produce performance guidelines published in the report focus strongly on the potential use of new products at district level in low income countries and include recommendations as to sensitivity, specificity, target patient population, matrix (specimen type), ease of use, equipment needs, stability, robustness, number of patient visits required to establish a diagnosis, and test cost.
The report highlights the poor function of existing diagnostic tools as they are routinely applied in the field and stresses the need for rapid, point-of-care tests that can be used while the patient is at the health care facility and that do not require multiple return visits. A number of new diagnostic tests are in development that intend to address some of these issues, and a brief summary of the status of some of these tests is presented.