Reference of the ERPD round : 23-NTD-0002
Concerning rk39 Rapid Diagnostic Tests (RDTs) for detection of visceral leishmaniasis disease
A. Background
The WHO Department of Control of Neglected Tropical Diseases (NTD) manages a diverse portfolio of twenty disease categories. For NTDs that require case management, diagnostics are the cornerstones of the control, elimination, or eradication goals of the programs as the intervention for this group of diseases primarily depends on detecting individual cases and surveillance of the diseases. For diseases targeted by preventive chemotherapy, diagnostic tests are required to support programmatic decisions on changing treatment frequency or stopping mass treatment, or to carry out surveillance and to validate or verify elimination.
Access to safe, appropriate, and affordable diagnostics of good quality is critical in achieving NTD targets set out by the 2021–2030 NTD road map. Recognizing that NTD in-vitro diagnostics (IVDs) are not yet covered by WHO Prequalification (PQ) programs, the NTD program decided to engage with the Expert Review Panel for Diagnostic Products (ERPD) program coordinated by WHO PQ team. The ERPD program aims to provide recommendations for procurement decisions and facilitate the supply of quality IVDs specifically intended for NTDs diagnostic. This collaborative effort between the WHO NTD program and WHO PQ team seeks to ensure that NTD programs have access to reliable and quality diagnostic products, supporting collective goals in disease control and elimination.
B. The Expert Review Panel for Diagnostic products (ERPD)
The Expert Review Panel for Diagnostics (ERPD) is an independent advisory body of technical experts, coordinated by WHO Prequalification. The role of the ERPD is to assess the risks and benefits associated with procurement of IVDs that may have a high public health impact but are not yet prequalified or that are not currently eligible for Prequalification. The risks of procurement and use of the products are considered in a specific binding context to determine their quality assurance risk category. The assessment is based on a desk review of available evidence of compliance to transparent criteria and will provide advice for decisions regarding time-limited procurement in specific conditions. ERPD Members are technical experts in the field of IVD performance, quality and safety and/or with extensive scientific knowledge and experience of diagnostic procedures in the relevant settings and disease area. The complete process involves the WHO NTD publishing an "Invitation to Manufacturers to Submit an Expression of Interest for Product Evaluation." Subsequently, manufacturers submit a diagnostic product questionnaire to WHO NTD, that will be submitted to the WHO PQ team who will coordinate the ERPD review. The results of the review are then communicated to the manufacturers by the WHO NTD program.
C. Scope of the present Invitation to Manufacturers
The present invitation focuses on: Visceral leishmaniasis rapid diagnostic tests
The purpose of this document is to invite manufacturers to submit an EOI for the product evaluation of urgently needed In-Vitro Diagnostics (IVDs) by WHO NTD. The invitation specifically pertains to a Visceral leishmaniasis rapid diagnostic IVD. Additionally, the document provides the required specifications or quality assurance criteria for these IVDs (see section 4 below).
Manufacturers whose IVDs are intended for Visceral leishmaniasis rapid diagnostic are encouraged to apply by completing a product submission form and necessary supporting documentation to WHO NTD. WHO PQ team, who will coordinate the ERPD review process and provide recommendations for procurement decisions and facilitate the supply of IVDs by WHO NTD.
D. Eligibility criteria
To be eligible for ERPD review, manufacturers must meet the following criteria:
Quality assurance criteria
- Quality management system: The manufacturer should provide evidence that the considered products are designed and manufactured under a relevant quality management system, such as ISO 13485 or equivalent standard.
- Operational capabilities: The manufacturer should provide evidence of their ability to support design, manufacturing, distribution, sales and post-market activities such as customer support, response to regulatory vigilance activities, in and for all WHO Member States involved in the management of visceral leishmaniasis.
- The application is limited to manufacturers who commit to submit their product to PQ (when eligible), SRA approval or registration in accordance with the product classification.
Technical criteria
To be eligible for ERPD review, the products must meet the following criteria:
- The submitted product shall meet the specific criteria set in section C above for visceral leishmaniasis rapid diagnostic tests and the submitted product shall be based on rk39 or rKE16 antigen-based tests.
- The submitted product shall use rapid test format and/or technologies that can be used at or near to point-of-care.
- The preferred criteria also include:
- Sample types should include whole blood, serum or plasma.
- The intended population criteria should be the population at risk in Eastern Africa and/or the Americas.
- Performance claims should meet or exceed the sensitivity and specificity requirements of Global Visceral Leishmaniasis Programme (sensitivity≥95%, specificity≥98%).
- A draft TPP is available as a reference at https://www.who.int/news-room/articles-detail/call-for-public-consultation-----target-product-profiles-(tpp)-for-visceral-leishmaniasis-diagnostics
E. Submission of documents for ERPD review
All manufacturers interested in submitting applications for review by the ERPD are kindly requested to submit the following information:
1. A cover letter expressing interest (Expression of Interest or EoI) in submitting the product to the ERPD for review. The cover letter should also indicate the authorized contact for the manufacturer.
2. One of the following documents, substantiated by the most recent inspection reports:
- An ISO 13485 certificate; covering the product manufacturing activities or
- A certificate ensuring that the IVD (device, reagents, and associated equipment) is manufactured at a site that is compliant with ISO 13485 requirements; or
- an equivalent quality management system recognized by a stringent regulatory authority of the Founding Members of the Global Harmonization Task Force (GHTF); or
- a letter from WHO ensuring that the manufacturing site has undergone inspection by the WHO Prequalification of In-Vitro Diagnostics Program and has been found compliant with WHO prequalification requirements.
3. The ERPD questionnaire, including all relevant attachments and evidence supporting product claims (refer to Annex 1)
The application must encompass all attachments that are accessible at the time of submission and that have been specified in the questionnaire. Additional information regarding any planned studies or documentation and the timelines can also be provided. It is imperative that all available evidence and the requested documents and information are comprehensively enclosed. If any of these items are missing or incomplete, a justification for their absence should be provided.
Incomplete Expressions of Interest, as well as those submitted after the Closing Date, will typically be disregarded unless WHO, at its discretion, decides otherwise.
F. Confidentiality
All information provided by manufacturers will be received by WHO NTD and shared with the WHO ERPD coordinator for the purpose of facilitating their review of the submission and provision of advice to WHO NTD. All parties involved will operate under a confidentiality agreement with WHO PQ as the coordinating entity . The outcomes of the ERPD review, as well as the advice provided in the review report, in connection with this Expression of Interest, will be shared with and used by WHO NTD and the relevant partners as the basis for procurement decisions.
G. Instruction for submission
Submission should be submitted by electronic means (either via email or web-based download service) to ERPD-NTD@who.int by the specified deadline (20 November 2023).