Reference of the ERPD Round: 25-NTD-0004
Concerning in vitro diagnostics (IVDs) intended to support onchocerciasis elimination programmes — specifically (i) mapping to determine where preventive chemotherapy (PC) should be started, and (ii) decisions to stop mass drug administration (MDA).
A. Background
The WHO Global Programme on Malaria and Neglected Tropical Diseases (MNT) manages a diverse portfolio of disease categories. For neglected tropical diseases (NTDs) that require case management, diagnostics are the cornerstone of the control, elimination, or eradication goals of the programmes, as the intervention for this group of diseases primarily depends on detecting individual cases and on surveillance. For diseases targeted by preventive chemotherapy, diagnostic tests are required to support programmatic decisions on changing treatment frequency or stopping mass treatment, and to carry out surveillance and to validate or verify elimination.
Access to safe, appropriate, and affordable diagnostics of good quality is critical to achieving the NTD targets set out in the 2021–2030 NTD road map. Recognizing that NTD IVDs are not yet in the scope of the WHO Prequalification (PQ) programme, the NTD programme decided to engage with the Expert Review Panel for Diagnostics (ERPD), an assessment mechanism coordinated by the WHO PQ team. The ERPD provides recommendations for procurement decisions and facilitates the supply of quality IVDs intended for NTD diagnosis. This collaboration between the WHO NTD programme and the WHO PQ team seeks to ensure that NTD programmes have access to reliable, quality diagnostic products, supporting collective goals in disease control and elimination.
B. The Expert Review Panel for Diagnostic products (ERPD)
The ERPD is an independent advisory body of technical experts, coordinated by WHO Prequalification. Its role is to assess the risks and benefits associated with the 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 assessment is based on a desk review of the available evidence of compliance with transparent criteria and provides advice on decisions regarding time-limited procurement under specific conditions.
ERPD members are technical experts in IVD performance, quality, and safety, and/or have extensive scientific knowledge and experience of diagnostic procedures in the relevant settings and disease area. The complete process involves WHO NTD publishing an “Invitation to Manufacturers to Submit an Expression of Interest for Product Evaluation.” Manufacturers then submit a diagnostic product questionnaire to WHO NTD, which is transmitted to the WHO PQ team to coordinate the ERPD review. The results of the review are communicated to manufacturers by the WHO NTD programme.
C. Scope of the present Invitation to Manufacturers
This invitation concerns in-vitro diagnostics (IVDs) intended to support onchocerciasis elimination programmes. Two distinct intended uses are covered by this call, each with its own target population and performance requirements as defined in the WHO Onchocerciasis Diagnostic Target Product Profile (TPP):
Use case| Use case | Intended use / programmatic decision | Target population | Min. sensitivity | Min. specificity |
|---|---|---|---|---|
| 1. Mapping | Detect exposure to O. volvulus to determine endemicity and guide the decision to START preventive chemotherapy (surveillance). | Adults | ≥ 60% | ≥ 99.8% |
| 2. Stop-MDA | Assess interruption of transmission to guide the decision to STOP mass drug administration (treatment/programmatic decision). | Sentinel school-aged children | ≥ 89% | ≥ 99.8% |
The minimal and optimal criteria for each use case are those set out in the WHO Onchocerciasis Diagnostic Target Product Profile to Support Preventive Chemotherapy (2021). Manufacturers should clearly state, in their submission, which of the two intended uses their product is intended to support; a product may be submitted for one or both.
The purpose of this document is to invite manufacturers to submit an EOI for the product evaluation of urgently needed IVDs. Section D sets out the eligibility (essential) criteria that a product must meet to be assessed, and the preferred (desired) information that WHO wishes to see in support of the submission.D. Eligibility criteria (essential)
To be eligible for ERPD review, a product must meet all of the following criteria. Failure to meet an eligibility criterion means the product will not be assessed.
Quality assurance criteria
- Quality management system: the manufacturer shall provide evidence that the products are designed and manufactured under a relevant quality management system, such as ISO 13485 or an equivalent standard.
- Operational capabilities: the manufacturer shall provide evidence of its ability to support design, manufacturing, distribution, sales, and post-market activities (such as customer support and response to regulatory vigilance) in and for all WHO Member States involved in the management of onchocerciasis.
- Regulatory commitment: the application is limited to manufacturers who commit to submit their product to WHO PQ (when eligible), to a stringent regulatory authority (SRA), or to national registration, in accordance with the product’s classification.
Technical criteria
To be eligible for ERPD review, the products must meet the following criteria:
- Intended use and performance: the product shall meet at least one of the intended uses in Section C and shall meet, at a minimum, the minimal performance criteria of the WHO Onchocerciasis Diagnostic TPP (2021) for the claimed use case(s).
- Test format and technology: a rapid diagnostic test (RDT) format, or a technology that can be used at or near the point of care, is optimal. A laboratory-based antibody-detection test (e.g., ELISA) is acceptable as a minimum
- Sample type: peripheral whole blood from a finger prick, or another easily collectable sample; for a laboratory-based test, peripheral whole blood from a finger stick, an EDTA/heparinized sample, or a dried blood spot (DBS). No venipuncture sampling shall be required.
- Time to result: < 0.5 h to a developed test result for a point-of-care test; < 48 h to a developed test result if a laboratory-based test is required.
E.
Preferred (desired) criteria
The following are not eligibility requirements. They describe additional information and types of study that WHO wishes to see in support of a submission and that will strengthen the evidence base for the ERPD review.
- Analytical specificity: studies and, in particular, the specimens/cross-reactants tested (e.g., Loa loa, Mansonella spp., Wuchereria bancrofti, and other filariae).
- Geographical coverage: clinical performance evaluated in at least two geographical settings.
- Intended population: a well-characterized intended population, ideally including all age groups resident in the defined endemic area, beyond sentinel school-aged children.
- Matrix equivalence: data comparing performance across sample matrices (e.g., whole blood vs DBS vs plasma).
- Specimen and product stability: real-time and accelerated stability data for the specimen and for the finished product under field-relevant temperatures.
- Optimal operational characteristics: suitability for use under “zero-infrastructure” conditions (community health centres, households, outdoor conditions); a developed test result that remains stable for up to 24 h; and a read time < 0.5 h.
Further details are provided in the WHO Onchocerciasis Diagnostic TPP to Support Preventive Chemotherapy.
F. Submission of documents for ERPD review
All manufacturers interested in submitting applications for review by the ERPD are kindly requested to submit the following:
- A cover letter expressing interest (Expression of Interest, EOI) in submitting the product to the ERPD for review. The cover letter should also indicate the authorized contact for the manufacturer.
- 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 compliant with ISO 13485 requirements; or
- an equivalent quality management system recognized by a stringent regulatory authority among the Founding Members of the Global Harmonization Task Force (GHTF); or
- a letter from WHO confirming that the manufacturing site has undergone inspection by the WHO Prequalification of In Vitro Diagnostics programme and was found compliant with WHO prequalification requirements.
3. The ERPD questionnaire, iincluding all relevant attachments and evidence supporting product claims.
The application must include all attachments that are available at the time of submission and that are specified in the questionnaire. Information on any planned studies or documentation, and the associated timelines, may also be provided. It is essential that all available evidence and the requested documents and information are comprehensively enclosed. If any 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 normally be disregarded unless WHO, at its discretion, decides otherwise.
G. Confidentiality
All information provided by manufacturers will be received by WHO NTD and shared with WHO PQ for the purpose of facilitating the review of the submission and the provision of advice to WHO NTD. WHO PQ will disclose to ERPD members the information provided by the manufacturer for the purpose of the ERPD review only. WHO PQ requires ERPD members to be legally bound by, and to abide by, the terms of the WHO PQ confidentiality agreement.
WHO NTD reserves the right to publish the outcomes of the ERPD review and to share the advice provided with the relevant partners as the basis for procurement decisions. Relevant partners include: the WHO Diagnostic Technical Advisory Group (DTAG) for NTDs; the Global Onchocerciasis Network for Elimination (GONE); the Expanded Special Project for Elimination of NTDs (ESPEN);
H. Instruction for submission
Submissions should be made by electronic means (either by email or via a web-based file-transfer service) to ERPD-NTD@who.int by the specified deadline (31 August 2026).