Diagnostics Evaluation Series No.4. Visceral Leishmaniasis Rapid Diagnostic Test Performance; 2011

Use of these results

This evaluation was designed to provide comparative data on the performance of submitted lots of each RDT tested. Ultimately, the results indicate that in clinical practice in the East African and South American region used alone VL RDT positive results may be adequate to direct treatment but inadequate to rule out a diagnosis of VL. This highlights the need to establish limits of acceptable performance and to implement RDTs within a diagnostic algorithm as appropriate for each global endemic area. In the ISC, all brands performed well. This performance data can be used to guide priority setting for field trials and/or procurement decisions. The final decision on product selection needs to be taken in a rational way, considering not only the minimal performance limits, but also the global endemic region, patient characteristics, experience of the intended users, climate and cost.