A bioassay method validation framework for laboratory and semi-field tests used to evaluate vector control tools.

Vector control interventions play a fundamental role in the control and elimination of vector-borne diseases. The evaluation of vector control products relies on bioassays, laboratory and semi-field tests using live insects to assess the product's effectiveness. Bioassay method development requires a rigorous validation process to ensure that relevant methods are used to capture appropriate entomological endpoints which accurately and precisely describe likely efficacy against disease vectors as well as product characteristics within the manufacturing tolerance ranges for insecticide content specified by the World Health Organization. Currently, there are no standardized guidelines for bioassay method validation in vector control. This report presents a framework for bioassay validation that draws on accepted validation processes from the chemical and healthcare fields and which can be applied for evaluating bioassays and semi-field tests in vector control. The validation process has been categorized into four stages: preliminary development; feasibility experiments; internal validation, and external validation. A properly validated method combined with an appropriate experimental design and data analyses that account for both the variability of the method and the product is needed to generate reliable estimates of product efficacy to ensure that at-risk communities have timely access to safe and reliable vector control products.