As part of the process for prequalification an IVD must undergo laboratory performance evaluation. Manufacturers can choose between organization of performance evaluation coordinated and financed by WHO (option 1), or performance evaluation coordinated and paid for by themselves (option 2). But whichever option is chosen, the evaluation must be performed by a WHO prequalification laboratory according to the appropriate standardized evaluation protocol for the corresponding type of assay.
The aim of the performance evaluation is to independently verify the manufacturer’s claim regarding product performance. In addition, if UN procurement criteria have been established, performance evaluation enables it to be determined whether these criteria have been met.
Prequalification performance evaluation is conducted under ideal conditions by trained laboratory technicians in one or several laboratories meeting international quality standards. In addition, evaluation collects operator’s feedback on operational characteristics and ease of use of the IVD being evaluated, in order to assess its usability in settings where laboratory capacity and the skills of laboratory technicians are limited.
A prequalification performance evaluation may be scheduled as soon as an IVD has been accepted for prequalification assessment. WHO will send a letter to the manufacturer detailing the conditions for organization of the performance evaluation according to the option selected and provide the current version of the applicable standardized protocol. If the manufacturer has selected option 1 (i.e. evaluation coordinated and financed by WHO), then WHO will also indicate in this letter which WHO prequalification laboratory will conduct the evaluation. Otherwise, under option 2, the manufacturer will be invited to select a WHO prequalification laboratory from among those listed for the appropriate analyte and to inform WHO of its selection once an agreement for performance evaluation has been reached.
The performance evaluation will be conducted by the laboratory selected according to the standardized protocol. Any adjustment of the protocol to a specific product must be discussed and approved by WHO before evaluation is initiated. The prequalification evaluation laboratory will oversee data cleaning, analysis and drafting of the report. The analysis and report are then verified by WHO, before being communicated to the manufacturer. The manufacturer will then have one month in which to submit any comments on the draft report. With due consideration to these comments, WHO will finalize the performance evaluation report and inform the manufacturer whether the results of the performance evaluation meet prequalification requirements.
If the product meets all WHO prequalification requirements, a summary of the results of the performance evaluation will be included in the Public Assessment Report that will be posted on this website. In addition, irrespective of whether or not the product meets WHO prequalification requirements, the results of the performance evaluation may be published in a peer-reviewed journal.