Our Expertise

Laboratory Systems Strengthening Community of Practice (LabCoP)

The Laboratory Systems Strengthening Community of Practice (LabCoP) is led by the African Society for Laboratory Medicine, with funding from the Bill & Melinda Gates Foundation. LabCoP is made up of a diverse group of stakeholders and country teams (currently 23) comprised of laboratorians, lab managers, clinicians, ministries of health, civil society, and others.

LabCoP fosters a south-south knowledge exchange and joint learning by linking together country teams from across Africa with global experts, and sharing the knowledge and best practices of laboratory systems strengthening amongst ministries of health. Topics include monitoring and evaluation (M&E), HIV viral load testing scale up, tuberculosis (TB), COVID-19 and more.

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.

HIV

A list of products will be available soon.

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

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.

Assay Verification Tool: designed to help laboratories implement new tests, making it easier to design, setup, and analyze data generated as part of a new test procedure validation verification.

Validation Timelines and Templates

Equipment

 

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 Acknowledgement

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