Background

WHO’s performance evaluation of in vitro diagnostics (IVD) aims at independently verifying the performance and operational characteristics of an IVD, including those that are considered essential for such IVD’s use in resource-limited settings. 

In 2025, WHO’s performance evaluation was revised to be a prerequisite to and a separate assessment procedure to WHO’s prequalification assessment, and certain IVDs must undergo a performance evaluation to be eligible for prequalification assessment. 

WHO’s performance evaluation is carried out by Performance Evaluation Laboratories (PELs), using standardized performance evaluation protocols. The PELs are laboratories that have been assessed by WHO and, based on desktop and on-site audit of their quality management system and ability to conduct WHO’s performance evaluation according to dedicated protocols, found to meet WHO requirements for performance evaluation. The procedure for becoming WHO performance evaluation laboratory is available here.

Who can participate in WHO’s performance evaluation and determining eligibility of the IVD for evaluation

Any manufacturer of an IVD can express an interest in having its IVD evaluated by WHO, provided that product is eligible for evaluation. Refer to the tables below and the document PQDx_459 “Eligibility criteria for WHO’s performance evaluation of in vitro diagnostics” (see guidance box below) for a full overview of the eligibility principles and criteria. 

Table 1: Products  currently eligible for WHO's perfomance evaluation as a prerequisite to apply for WHO's prequalification assessestment ^a  

Table updated: 15 December 2025 

^a For multiplex tests, the manufacturer is requested to contact WHO in advance of submitting an EOI.

^b If no claimed specimen types are included in the table above, the manufacturer is requested to contact WHO in advance of submitting an EOI.

^c Including rapid diagnostic tests intended for self testing
 

Table 2: Products for which WHO’s performance evaluation is not required as a prerequisite to apply for WHO’s prequalification assessment  

Table updated: 15 December 2025 

¹ HPV NAT assays WHO has adopted the fulfilment of Meijer’s criteria in independent evaluations as the independent performance evaluation for HPV nucleic acid tests used to inform WHO’s decision on prequalification link here

 [1] HPV NAT assays WHO has adopted the fulfilment of Meijer’s criteria in independent evaluations as the independent performance evaluation for HPV nucleic acid tests used to inform WHO’s decision on prequalification link here 

Applying for WHO's performance evaluation

As a first step in WHO’s performance evaluation process, the manufacturer must submit to WHO an Expression of Interest form (using document PQDx_460 “Expression of interest form for WHO’s performance evaluation of in vitro diagnostics”) together with the necessary supporting documentation and following the instructions provided in the document PQDx 461 “Instructions for completion of the Expression of interest form for WHO’s performance evaluation of in vitro diagnostics”.

WHO will notify the manufacturer in writing of the outcome if the EOI submission. If WHO determines that the product in question is eligible for WHO’s performance evaluation, WHO will provide the manufacturer instructions on the next steps.

Performance evaluation commissioning options

When submitting the Expression of Interest for WHO’s performance evaluation, the manufacturer must choose one of the following two options for the commissioning of WHO’s performance evaluation:  

Option A: WHO’s performance evaluation commissioned by the manufacturer and carried out by a PEL selected by the manufacturer. If this option is chosen, the manufacturer will be responsible for commissioning and coordinating WHO’s performance evaluation directly with the PEL selected by the manufacturer; and directly paying all fees. 

Option B: WHO’s performance evaluation commissioned by WHO and carried out by a PEL selected by WHO. If this option is chosen the manufacturer will be responsible for paying directly to WHO an amount equal to all fees in connection with WHO’s performance evaluation of the product in question, and the associated WHO coordination cost, as determined and communicated by WHO. Provided that the aforementioned amount has been fully paid by the manufacturer, WHO will coordinate WHO’s performance evaluation with the PEL selected by WHO.

Performance evaluation fees

All fees, costs and expenses arising from WHO’s performance evaluation of a given product are required to be fully covered by the manufacturer. Refer to the guidance document PQDx_462 “WHO’s Performance evaluation fees” (see guidance box below) for more information.

Procedure for performance evaluation

Irrespective of the option chosen, the performance evaluation must be carried out in accordance with a WHO protocol developed in collaboration with international experts. The evaluations usually include a verification of the clinical performance (sensitivity, specificity), as well as analytical performance (analytical sensitivity, precision, lot to lot variations, etc.). In addition, operational characteristics and ease of use are assessed to inform use in settings with limited infrastructure. Where different specimen types with different performance characteristics (e.g. limit of detection and/or sensitivity and specificity) are claimed, a full performance evaluation will be conducted on one of the specimen types and a limited verification will be conducted on the other specimen type. This limited evaluation will also be conducted if specimen types with different performance characteristics are added as a change request to a prequalified product.  

If WHO determines that the product meets, to WHO’s satisfaction, the technical requirements for WHO’s performance evaluation in accordance with WHO’s performance evaluation protocol, then WHO will publish a summary of the results of WHO’s performance evaluation in the Performance evaluation public assessment report link here.

If, on the other hand, WHO determines that the product does not meet, to WHO’s satisfaction, the technical requirements for WHO’s performance evaluation in accordance with WHO’s performance evaluation protocol, then the application will be terminated.

Performance evaluation as a pathway to WHO’s prequalification assessment

The performance evaluation and the final performance evaluation report will be used by WHO to inform its decision on whether or not the IVD in question is accepted for assessment under WHO’s prequalification procedure, and/or if applicable, is granted WHO’s prequalification listing.

If WHO determines that the product does not meet, to WHO’s satisfaction, the technical requirements for WHO’s performance evaluation in accordance with WHO’s performance evaluation protocol, then the prequalification application will be rejected/terminated.