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(2016; 22 pages)
The purpose of this document is to provide technical guidance to in vitro diagnostic medical device (IVD) manufacturers that intend to seek WHO prequalification of IVDs for the detection of glucose-6- phosphate dehydrogenase (G6PD) deficiency.
Where possible, WHO performance conditions are aligned with published guidance, standards and/or regulatory documents. Although references to source documents are provided, in some cases WHO has additional requirements. For prequalification purposes, manufacturers must provide evidence in support of the clinical performance of an IVD which can demonstrate that reasonable steps have been taken to ensure that a properly manufactured IVD, being correctly operated in the hands of the intended user, will detect the target analyte and fulfil its indications for use.
Prequalification requirements summarized in this document do not extend to the demonstration of clinical utility, i.e. the effectiveness and/or benefits of an IVD, relative to and/or in combination with other measures, as a tool to inform clinical intervention in a given population or healthcare setting. To demonstrate clinical utility, a separate set of studies is required. Clinical utility studies usually inform programmatic strategy and are thus the responsibility of programme managers, ministries of health and other related bodies in individual WHO Member States. Such studies do not fall under the scope of prequalification.