The Diagnostic Evidence Hub is a knowledge platform that provides national reference laboratories, national regulatory authorities, and diagnostics stakeholders with key information from published studies on the technical performance of new in vitro diagnostic products. It seeks to improve access to publicly available technical data in order to inform decision-making and support in-country registration and adoption of new, impactful, and quality-assured diagnostic products.

Regulatory decision making with regards to the quality, safety and performance of medical devices and in vitro diagnostics highly depends on expertise that is available within laboratories. Good reliance practices in regulatory decision-making promote efficiencies and allows regulators to focus their efforts on critical activities.

Leveraging the output of others whenever possible, such as work done by WHO Prequalification and independent evaluations by renowned bodies, may avoid unnecessary repeat evaluations that may not add value, but delay the adoption of new impactful technologies.

New Diagnostic Products

Click on a category below to explore the available products.

Only products that have been WHO prequalified have been included. Products that receive WHO prequalification in the future will be added to the Hub.

ASLM and partners do not endorse any specific manufacturers. Products are listed alphabetically.

Evaluation and Verification Resources

Listed below are resources that can be used by laboratories for method verification and validation when a new diagnostic is introduced into a national program. 

Verification, intended for assays used without modification, is conducted as part of good laboratory practice, fulfilling requirements of internal quality standards to confirm with evidence that manufacturer performance claims have been met. Calculations are based on experimental data, often using very minimal numbers of samples between 10 to 20.

Validation, a more complex process, is required for modified or “in-house” tests. Validation is necessary if a standard method has been modified or is used outside its intended scope. Similar to verification, tests are validated according to clinical test purpose and impact of the result on the clinical decision. Technical specifications to be evaluated (e.g., error rate, allowable specificity and sensitivity) are selected accordingly.

Note: In some cases there have been calls for in-country performance evaluations that have duplicated efforts by independent bodies such as WHO PQ and have delayed in-country registration. It is highly recommended, especially in low resource settings, that national authorities rely on performance evaluation data from similar settings (see data in New Diagnostic Products) to support in-country registration efforts.

Other Useful Resources

WHO PQ Regulation and Prequalification (RPQ)

Facilitates access to safe, reliable, and appropriate in vitro diagnostics (IVDs) and laboratory services in an equitable manner, with a focus on IVDs for priority diseases and their suitability for use in resource-limited settings

Africa Medical Devices Forum (AMDF)

A technical committee under the African Medicines Regulatory Harmonisation (AMRH) initiative, AMDF focuses on building effective regulatory networks for IVDs and medical devices

International Medical Device Regulatory Forum

Discusses future directions in medical device regulatory harmonisation and works to accelerate international medical device regulatory harmonisation and convergence

International Diagnostics Center

Facilitates the development, evaluation, and implementation of accessible, quality assured IVDs for global health through information sharing and advocacy

ASLM Resource Center

Additional resources posted on ASLM’s website resource center

Partner Acknowledgment

With support from the U.S. President’s Emergency Plan for AIDS Relief, through the African Society for Laboratory Medicine, Catholic Relief Services and Clinton Health Access Initiative