Performance Evaluation Laboratories
Independent laboratory performance evaluation of in vitro diagnostics (IVDs) submitted for prequalification assessment enables WHO to verify certain standards of performance that are considered essential for resource-limited settings.
Manufacturers who wish to submit a product for prequalification have two options with respect to meeting the performance evaluation requirement of prequalification assessment: performance evaluation coordinated and financed by WHO (option 1), or performance evaluation coordinated and paid for by themselves (option 2). But whichever option a manufacturer chooses, the evaluation must be performed by a designated Performance Evaluation Laboratory (PEL).
Laboratories that successfully apply to become a performance evaluation laboratory contribute to WHO's aim to increase access to IVDs for accurate diagnosis and monitoring of priority disease and conditions. In brief, such laboratories are a key partner for WHO prequalification.
Who can apply for listing as a performance evaluation laboratory?
Applications are open to laboratories with experience in conducting independent performance evaluations of IVDs, including:
- WHO Collaborating Centres.
- National laboratories or laboratories that provide testing services to the government in their respective country.
- Laboratories located in geographical areas corresponding to the intended setting of use of the IVDs submitted for assessment.
Due to a sufficient number of PELs for the evaluation of IVDs for the diagnosis and/or monitoring of infection for HIV (including CD4), syphilis, hepatitis B, hepatitis C, applications for these analytes are currently closed.
Currently, applications are open for the following types of tests:
- Human papilloma virus molecular tests
- G6PD deficiency
- TB molecular tests.
Requirements for WHO listing
WHO requirements for listing of a performance evaluation laboratory are specifically related to performance evaluations. An assessment will ascertain the potential for a laboratory to undertake a performance evaluation according to the relevant WHO protocol, as well as the laboratory’s compliance with the principles of ISO/IEC 17025:2005 and ISO 15189:2012. Additional references relating to good practice for laboratories performing IVD evaluations, including other ISO standards, will be referred to during the audit. The auditing process is based on the principles outlined in ISO 19011:2018.
More information about audit Stages 1 and 2, WHO and laboratory responsibilities (with respect to the on-site audit), organization and output of the on-site audit, and the principles that audits adhere to, are given below.
Assessment of a candidate laboratory consists of:
- Submission by the laboratory of an EOI.
- Stage 1 audit: assessment by WHO of the EOI and the specific quality management system (QMS) documentation submitted by the manufacturer.
- Stage 2 audit: on-site audit by WHO of the laboratory to assess compliance with WHO requirements.
- If the laboratory meets all requirements, listing of the laboratory as a WHO Performance Evaluation Laboratory.
Laboratories that meet assessment requirements will be informed by letter of their listing as a WHO Prequalification Evaluating Laboratory.
Performance Evaluation Laboratories must ensure ongoing compliance with WHO requirements following listing.
Mandatory re-assessment, to verify ongoing compliance with WHO requirements and relevant standards, takes place every three to five years after laboratory listing. It takes the form of a partial or full audit. However, re-assessment may be carried out sooner than this if deemed necessary. In addition, WHO may decide to delist laboratories should they fail to deliver the agreed work (compliance with the protocol, agreed timeline) or to communicate adequately with WHO.