On 30 January 2020, the Director-General declared that the outbreak of COVID-19 caused by SARS-CoV2 constitutes a Public Health Emergency of International Concern (PHEIC) and on 11 March 2020 it was characterized as a pandemic. In vitro diagnostics (IVDs) of assured quality, safety and performance are a critical component of an overall strategy to control the pandemic.

The WHO Emergency Use Listing procedure was developed to expedite the availability of IVDs needed in public health emergency situations. It is intended to assist procurement agencies and Member States with their decisions regarding the suitability for use of a specific IVD, based on a minimum set of available quality, safety, and performance data.

The procedure is currently open to candidate IVDs to detect SARS-CoV-2 (previously called 2019-nCoV).

Priority categorization of applications for prequalification and Emergency Use Listing (EUL) assessment of IVDs

Applications are currently prioritized as follows:

High priority:

• EUL applications for SARS-CoV-2 antigen detection tests
• EUL applications for SARS-CoV-2 nucleic acid detection tests intended to be used at a point of care.

Medium priority:

• prequalification applications
• EUL applications for SARS-CoV-2 nucleic acid detection tests.

All other submissions/requests are currently assigned a lower priority.

Change notifications are prioritized on a case-by-case basis.

Please also note that due to the current peak in applications under assessment that the Prequalification Unit is only accepting EUL pre-submission call requests and new expressions of interest in EUL assessment for the above high- and medium-priority applications.

IVDs eligible for EUL submission

Currently, the following IVDs are eligible for EUL submission:

• assays for the detection of SARS-CoV-2 nucleic acid (multiplex assays, detecting more than one viral target)
• rapid diagnostic tests for the detection of SARS-CoV-2 antigens; other platforms to detect SARS-CoV-2 antigen will be considered on a case-by-case basis. Please contact diagnostics@who.int for further information.

Instructions for manufacturers, detailing the technical documentation to be submitted, can be found below.

WHO procedure

WHO will review all documentation submitted in order to assess available evidence in support of the product’s safety, quality and performance.

Currently, several performance evaluations of SARS-CoV-2 IVDs are being carried out by regulatory authorities, reference laboratories and other stakeholders in various regions. Manufacturers are strongly encouraged to participate in initiatives which generate evidence that can be used to support their EUL submission. However, participation in external evaluations does not replace the EUL submission, nor is participation in such studies mandatory for submission for WHO EUL.