Quality Assurance for Rapid Tests

Quality assurance program materials for onchocerciasis and lymphatic filariasis tests

Below you can access training, quality assurance (QA) and quality control (QC) materials created to support use of rapid diagnostic tests for onchocerciasis and lymphatic filariasis (LF). Materials are provided in English (Eng) and in French (Fr).

Contact dxinfo@path.org to request training, proficiency, and QA panels, and positive and negative QC samples.

Why is quality assurance important?

Quality assurance (QA) is essential for programs to monitor and improve the quality of diagnostic testing. QA is all of the systematic activities that demonstrate confidence that a product or service fulfills its requirements. (International Organization for Standardization) A QA program for diagnostics is designed to guarantee that the final diagnostic results reported by a laboratory or testing program are as accurate as possible. The process includes providing diagnostic test operators with quality training as well as verifying that tests perform as intended, giving program managers greater confidence in their test results. An important component of any QA program is quality control (QC) measures to indicate whether the test run was valid and produced acceptable results. Implementing diagnostic testing with rapid tests in parallel with a QA program reinforces the validity of the test results, builds capacity to use rapid tests for surveillance and research, and aligns with global guidance and best practices for the post-market surveillance of new diagnostic tools. A robust QA program benefits test developers, manufacturers, distributors, funders, policy makers, key stakeholders, and most importantly, the patients or communities where the diagnostics are used.