Answers to Product Validation Support

The following agencies are actively engaged in product validation in diagnostics and can be contacted by test developers who have a product that is ready for evaluation:



1.  FIND ( Foundation for Innovative New Diagnostics)




2.  PATH (Program for Appropriate Technology in Health)





3. Tuberculosis Clinical Diagnostics Research Consortium (CDRC)



clinton initiative

 4. Clinton Health Access Initiative (CHAI)



In addition, a large number of academic institutions conduct evaluation of TB diagnostics.

However, assay developers and manufacturers need to confirm with the national regulatory authority in the country where they are interested in marketing in the usage of data generated and collected in a specific country where validation study is carried out. I.e. in order for a diagnostic product to enter Chinese market, manufacturers need to provide validation data from at least one study conducted in China. 

About the guidance of test accuracy studies and clinical impact studies:

Refer to GHTF guidance, now maintained on the IMDRF website. Particularly, STED will become the global standard which is already followed by WHO, Australia, and EU.



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