In vitro diagnostics and laboratory technology

Coronavirus disease (COVID-19) Pandemic – Emergency Use Listing Procedure (EUL) open for in vitro diagnostics

On 30 January 2020, the Director-General declared that the outbreak of 2019-nCoV constitutes a Public Health Emergency of International Concern (PHEIC). The WHO Emergency Use Listing (EUL) is open to candidate in vitro diagnostics (IVDs) to detect SARS-CoV-2 (originally called 2019-nCoV).

Since 28 February 2020, manufacturers of IVDs for the detection of SARS-CoV-2 nucleic acid are invited to submit an Expression of Interest (EoI) for assessment of candidate IVDs under the EUL procedure. On 17 April WHO extended the invitation to manufacturers of rapid diagnostic tests (RDTs) intended for antibody detection. On 9 June the call for EoI was extended to Immunochromatographic (lateral flow) or Immunofiltration (flow through) rapid diagnostic test to detect SARS-CoV-2 antigens. On 3 July the EUL pipeline was further expanded to antibody detection enzyme immunoassays (EIAs).

Invitation to manufacturers of in vitro diagnostics for SARS-CoV-2 to submit an application for emergency use listing by WHO

The EUL procedure is developed to expedite the availability of IVDs needed in public health emergency situations. It is intended to assist interested procurement agencies and Member States on the suitability for use of a specific IVD, based on a minimum set of available quality, safety, and performance data.

Manufacturers who are interested in an EUL submission for assays to detect SARS-CoV-2 are invited to contact to arrange a pre-submission meeting/call. Please note that applications won’t be accepted without prior consultation with WHO.

Currently, the following IVDs are eligible for EUL submission:

  • Assays for the detection of SARS-CoV-2 nucleic acid;
  • Immunoassays for the detection of SARS-CoV-2 specific antibodies; and
  • Rapid diagnostic tests for the detection of SARS-CoV-2 antigens.

Instructions for manufacturers detailing the technical specifications for the documentary evidence can be found below.

Instructions for Submission Requirements: In vitro diagnostics (IVDs) Detecting Antibodies to SARS-CoV-2 virus

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 implemented by regulatory authorities, reference laboratories and other stakeholders in various regions. Manufacturer are strongly encouraged to participate in initiatives which generate evidence that can be used to support the EUL submission, However, participation external evaluations does not replace the EUL submission nor is participation in such studies mandatory for submission to the WHO EUL.

Frequently asked questions and answers to EUL assessment of IVD to detect SARS-CoV-2 or anti-SARS-CoV-2 antibodies

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