History

In 1988 WHO created the Test Kit Evaluation Programme, having observed that the performance of HIV diagnostic assays, developed mainly in Europe and the USA, were greatly reduced when used for African populations. The quality of assays was assessed through performance evaluations ― using a panel of specimens from broad geographic origins, to verify performance in different populations. The programme was later expanded to include other diseases. Over time, though, many more assays become commercially available and many manufacturers moved their manufacturing sites to countries with weak regulation. In 2010 a new programme for prequalifying in vitro diagnostics (IVDs) and medical devices, that took into account the rapidly changing diagnostics landscape, and focused on diagnostics and medical devices for priority diseases, was launched.

WHO prequalification of male circumcision devices (MCDs) started in 2011, in support of HIV prevention programmes with the aim of promoting and facilitating access to safe, appropriate and affordable male circumcision devices of assured quality, in an equitable manner. The results of evaluation form the basis of technical recommendations provided principally to other UN agencies, but also to WHO Member States and other interested organizations, on selected male circumcision devices.

Vision and mission

The vision of WHO in vitro diagnostics prequalification is to increase access to quality, safe, and effective IVDs, for all, and to MCDs.

WHO in vitro diagnostics prequalification is committed to contributing to achievement of Universal Health Coverage, to ensuring healthy lives, to promoting well-being for all at all ages (Sustainable Development Goal 3),  and to facilitating access to affordable IVDs and MCDs.

Strategy

WHO's strategy for achieving this vision incorporates:

• application of internationally-recognized standards and best international practice with respect to quality, safety and performance
• prequalification of IVDs and MCDs through comprehensive evaluation of their quality, safety and efficacy and appropriateness for use in resource-limited settings, based on information submitted by the manufacturers, performance evaluation in the case of IVDs, and inspection of the corresponding manufacturing sites

Key outputs

The outputs of WHO prequalification of IVDs and MCDs are the:

• WHO List of Prequalified In Vitro Diagnostic Products
• WHO List of Prequalified Male Circumcision Devices
• WHO List of Prequalification Evaluating Laboratories
• WHO Public Assessment Reports 
• WHO Public Inspection Reports

Contribution to WHO goals

WHO is striving hard to attain universal health coverage, including by improving access to quality essential services and to essential products. Quality-assured IVDs are indispensable for diagnosis and monitoring of diseases, prognosis and prediction of treatment response, and optimization of health expenditure. IVD prequalification is clearly integral to WHO's programme of wok and mandate.