WHO publishes specifications for monkeypox tests
The World Health Organization (WHO) has recently unveiled two pivotal Target Product Profiles (TPPs) for monkeypox diagnostic test specifications. As the diagnostic landscape evolves, it becomes imperative for diagnostic manufacturers to align with these international benchmarks. MDx CRO stands at the forefront as a strategic IVD CRO and regulatory consulting partner ready to navigate these benchmarks with precision and compliance.
The creation of monkeypox test specifications was underpinned by a comprehensive process, involving a myriad of experts from fields such as science, public health, and regulation. A crucial step involved a public consultation phase, ensuring the TPPs were refined with broad feedback before finalization. This initiative by WHO is a hallmark in the trajectory of creating robust diagnostic tools for monkeypox and related orthopoxviruses.
Deciphering WHO’s TPPs
The intended patient population in both TPPs are individuals suspected of monkeypox infection, including children and adults.
1. TPP1: NAAT assays
TPP1 is tailored for NAAT (nucleic acid amplification tests) qualitative diagnostic test applications within healthcare settings and laboratories. It is also relevant for point of care facilities, such as a outpatient, STI clinic, emergency units or other near-patient settings. It mandates a test that boasts high diagnostic sensitivity (≥95%), specificity (≥97%) when compared to a reference molecular method.
- Sample type: lesion material or mucosal swabs (excluding saliva).
- Intended user: The test is intended for laboratory personnel or trained healthcare professionals (when used near-patient).
- Instrumentation: Closed molecular systems and tests that do not require extraction prior to amplification/detection are preferred.
- Test design: 2 independent target regions with at least one target that is monkeypox specific. The IFU should specify the assay’s target region.
- Time to result: Results should be obtained in under 4 hours and preferably under 1 hour.
2. TPP2: Lateral flow immunoassays
In contrast, TPP2 describes immunoassay based tests that aid the diagnosis of orthopoxvirus antigens. These are typically qualitative lateral flow assays tailored for decentralized used, including in the community, rural environments and low-resource settings. Results should be interpreted visually and/or through digital readout via smartphone. Tests should demonstrate adequate diagnostic sensitivity (≥80%), specificity (≥97%) for community based settings when compared to a reference molecular method.
- Sample type: lesion material, mucosal swabs or saliva. When present, lesions are the preferred sample type.
- Intended user: The test should be designed for use by non-lab trained intended users.
- Test design: The target analyte is the monkeypox virus antigen/protein. Tests targeting monkeypox antibody detection are not acceptable.
- Time to result: Results should be obtained quickly in under 40 minutes and preferably under 20 minutes, a crucial feature for time-sensitive environments such as outbreak regions or remote settings
Partnering with MDx CRO for your monkeypox test development
MDx CRO is unwavering in its commitment to support the development and clinical trials that meet monkeypox diagnostic test specifications. Our services encompass areas such as IVD clinical performance study design, clinical site qualification, efficient sample collection and analysis, IVD study monitoring activities and stringent regulatory compliance across multiple jurisdictions, with an emphasis on CE marking under the IVDR.
While the TPPs provide an essential blueprint, the diagnostic journey also demands attention to several critical facets:
- Study Populations: Defining the optimal study population is paramount. Such a population should encompass individuals potentially benefiting from the test, including those suspected of monkeypox or those at elevated risk of exposure.
- Reference Standards: Leveraging appropriate reference standards ensures validation of the test’s accuracy and reliability, forming the backbone of its developmental and evaluative processes. Samples should cover a range of viral loads as per the reference method used.
- IVD Clinical Study Design of monkeypox tests should include prospective or leftover specimens and should be designed to cover a clinically relevant viral load. MDx CRO can help design and execute clinical performance studies in alignment with the WHO TPP and IVDR CE mark expectations.
With the scientific acumen and regulatory insights of MDx CRO, diagnostic manufacturers can confidently navigate the intricacies of the WHO’s TPPs and other global benchmarks.
Planning to develop an IVD monkeypox test or to conduct an EU based clinical trial?
Contact us today to find out how MDx CRO can accelerate your development journey.