Testsealabs dengue rapid diagnostic test — aligned with WHO ERPD 2025 evaluation criteria for ministry of health procurement programs.

On May 22, 2025, the World Health Organization activated its Expert Review Panel for Diagnostics (ERPD) in response to the ongoing global dengue emergency. The panel’s mandate was clear: evaluate commercially available dengue diagnostic tests against a defined set of quality and performance criteria, and publish a list of products deemed suitable for procurement by member states and international health organizations. Seven diagnostic products were approved in the initial review. This event, while framed as an emergency measure, has fundamentally changed how ministries of health and procurement agencies evaluate dengue rapid diagnostic test suppliers.

For IVD manufacturers and distributors who serve the public health channel, understanding the ERPD evaluation framework is no longer optional — it is becoming the de facto procurement standard for WHO member states responding to the dengue crisis. And while Testsealabs’ dengue combo test is not yet on the ERPD list, the evaluation criteria the panel used provide a clear roadmap for any manufacturer seeking to compete in the public health procurement space.

As the International Sales Director at Testsealabs, I have spent a decade supporting distributors and public health buyers in dengue-endemic countries. The ERPD represents the most consequential policy intervention in dengue diagnostics since WHO issued its first dengue diagnostic guidelines. This article breaks down what the ERPD actually evaluates, what it means for procurement officers, and how suppliers can align their product and documentation strategies with this new standard.

Why WHO Activated the ERPD for Dengue

The 2024–2025 global dengue emergency was unprecedented in scale. The Pan American Health Organization reported over 12.6 million suspected dengue cases across the Americas in 2024 — more than triple the 2023 total — with Brazil, Argentina, Colombia, and Mexico disproportionately affected. Southeast Asia, particularly Vietnam, Thailand, and Indonesia, also experienced case surges beyond historical baselines. Climate change, urbanization, and the expanding geographic range of Aedes aegypti and Aedes albopictus mosquitoes have created conditions for sustained transmission in regions that were historically low-risk.

Against this backdrop, the WHO identified a critical gap: while numerous dengue rapid diagnostic tests were commercially available, there was no centralized, expert-driven evaluation framework to guide procurement decisions. The existing WHO prequalification program covers a limited range of diagnostic products, and dengue RDTs — despite their widespread use — had not been systemically evaluated against a uniform standard. The ERPD was activated to fill this gap on an emergency basis.

The panel conducted a systematic review of available dengue diagnostic products, evaluating technical files, clinical performance data, manufacturing quality certifications, and stability documentation. The seven products that passed this review were listed for a one-year validity period, with the option for manufacturers to submit additional products for evaluation during the validity window.

The full list of ERPD-reviewed products is maintained on the WHO ERPD product list, a document that procurement officers now consult before issuing tenders for dengue diagnostics.

The Four Evaluation Pillars of the ERPD Framework

The WHO ERPD evaluation criteria for dengue diagnostics rest on four pillars. Understanding each of them is essential for any manufacturer preparing a product submission or any procurement officer evaluating supplier proposals.

Pillar 1: Clinical Performance Across the Infection Timeline

The ERPD requires sensitivity and specificity data for each analyte detected by the test. For dengue combo tests that simultaneously detect NS1 antigen and IgG/IgM antibodies, this means the manufacturer must submit separate performance data for NS1 detection and for antibody detection. The panel evaluates whether these performance metrics meet clinically meaningful thresholds — specifically, whether the test can reliably detect dengue infections during both the acute phase (days 1–4, when NS1 is the primary marker) and the early convalescent phase (days 4–7, when IgM becomes detectable).

The Testsealabs Dengue IgG/IgM+NS1 Antigen Test is designed as a rapid chromatographic immunoassay that detects both NS1 antigen and IgG/IgM antibodies simultaneously from whole blood, serum, or plasma, with results available within 15 minutes. While the test has not been submitted for ERPD review, its technical file includes individual performance data for each of the three analytes — NS1, IgM, and IgG — which is the level of detail that ERPD evaluators expect.

Pillar 2: Quality Management System Certification

ERPD evaluation requires evidence that the manufacturing facility operates under a certified quality management system. ISO 13485 certification is the internationally recognized standard for medical device quality management, and MDSAP certification — which consolidates regulatory audits from five participating countries — provides additional evidence of manufacturing quality. Testsealabs holds both ISO 13485 and MDSAP certifications, meeting this pillar of the ERPD evaluation framework.

Pillar 3: Stability and Environmental Robustness

Dengue-endemic countries are concentrated in tropical and subtropical climate zones where ambient temperatures regularly exceed 30°C. The ERPD evaluates whether the product’s claimed storage temperature range and shelf life are supported by real-time and accelerated stability data. Products that require cold chain storage or have short room-temperature stability are disadvantaged in the ERPD evaluation. Testsealabs’ dengue combo test stores at 4–30°C with a 24-month shelf life, specifications that align with the operational requirements of dengue-endemic public health settings.

Pillar 4: Compliance with WHO Diagnostic Guidelines

The ERPD evaluates whether a product’s intended use, performance characteristics, and operational specifications align with WHO’s published guidelines for dengue diagnosis and case management. This includes the recommendation that diagnostic strategies combine NS1 antigen testing (for acute-phase detection) with serological testing (for late acute and convalescent-phase detection). Combo tests that cover both NS1 and antibodies in a single device align more closely with WHO guidance than single-analyte tests.

What the ERPD Means for Procurement Officers

For ministries of health and procurement agencies, the ERPD product list has become a de facto reference for tender evaluation. Several implications are already visible across procurement programs in dengue-endemic countries:

ERPD listing simplifies tender evaluation. Procurement officers can reference the ERPD list as an evidence-based pre-screening tool, reducing the technical evaluation burden on individual tender committees. Products that are ERPD-listed face a streamlined evaluation pathway, while non-listed products must provide equivalent evidence of meeting the same performance and quality thresholds.

National regulatory authorities are adopting ERPD criteria. Several national regulatory bodies in Latin America and Southeast Asia have announced that they will accept ERPD evaluation documentation as part of their in-country registration processes for dengue diagnostics. This creates a regulatory convergence that benefits both procurement agencies and manufacturers.

One-year validity creates a rolling evaluation cycle. The ERPD listings are valid for one year, after which manufacturers must resubmit updated documentation. This creates a continuous improvement incentive — manufacturers cannot rest on a single approval but must maintain their quality systems, update their clinical evidence, and remain responsive to evolving WHO guidelines.

Practical Procurement Implications: What Changes When ERPD-Criteria Are Applied to Tender Evaluation

The ERPD framework introduces changes that are directly observable in how ministries of health and international procurement agencies evaluate dengue RDT tender submissions. I have identified four specific shifts that procurement officers should be aware of when designing their evaluation criteria, and that suppliers should anticipate when preparing their technical documentation.

First, the emphasis on individual-analyte performance data changes how combo tests are evaluated. Previously, many tender committees accepted a single sensitivity and specificity number for the entire test product. Under the ERPD framework, the evaluation must consider NS1 detection performance separately from IgG/IgM detection performance. This means that a combo test with excellent antibody detection but marginal NS1 sensitivity — or vice versa — will be identified during evaluation rather than being masked by an aggregate performance claim. For the supplier, this means that the technical file must present clinical performance data stratified by analyte, not aggregated across the test device.

Second, the shelf life and storage temperature requirements are becoming standardized. The ERPD evaluation applies consistent criteria for product stability across all submitted products. This standardization means that procurement officers can compare the stability profiles of different products on an apples-to-apples basis, rather than trying to reconcile stability claims based on different testing protocols. Products that can demonstrate 24-month room-temperature stability at 30°C are positioned to score higher on this evaluation criterion than products with shorter shelf lives or narrower storage temperature ranges.

Third, the manufacturing quality documentation requirements have been codified. The ERPD framework specifies exactly which quality management system certifications are acceptable and what documentation is required to verify them. This eliminates the ambiguity that previously existed in tender evaluation processes, where different committees might accept different levels of quality documentation. ISO 13485 certification is the baseline, and MDSAP certification provides additional evidence of manufacturing quality.

Fourth, the ERPD evaluation creates a documented trail of product performance comparisons. Procurement officers can reference the ERPD evaluation reports to understand how a particular product performed against the established criteria, and whether any performance limitations were noted during the review. This transparency reduces the risk of selecting a product with undisclosed performance weaknesses — a risk that was more difficult to manage in the pre-ERPD evaluation environment where each tender committee conducted its own isolated evaluation.

For suppliers who have not yet submitted their products for ERPD review, these four shifts provide a practical roadmap for strengthening their technical documentation and product positioning in anticipation of future submission cycles.

Abbott Bioline Dengue Duo and the Competitive Benchmark

The Bioline Dengue Duo employs a dual-plastic-cassette format with separate NS1 and IgG/IgM test strips housed in a single device. It has been widely evaluated in field studies across Latin America and Southeast Asia, with published sensitivity and specificity data available in peer-reviewed literature. For procurement officers evaluating alternative suppliers, the key question is not whether the Bioline Dengue Duo performs well — the published evidence clearly supports its clinical utility — but whether the alternative product offers comparable performance at a more competitive price point, with equivalent quality assurance, and with supply chain terms that meet the program’s operational needs. These are exactly the evaluation criteria that the ERPD framework is designed to standardize.

The Abbott Bioline Dengue Duo (NS1 Ag + IgG/IgM combo) is one of the most widely recognized products in the dengue RDT space and was evaluated alongside other submissions in the ERPD process. Its market presence provides a useful benchmark for procurement officers evaluating alternative suppliers. The key competitive factors beyond ERPD listing include unit pricing for bulk procurement (typically evaluated on a cost-per-result basis rather than unit cost alone), supply chain reliability and manufacturing capacity, and the comprehensiveness of the manufacturer’s post-market support including training materials and technical assistance.

For a complete overview of the dengue diagnostic products Testsealabs offers, I encourage procurement officers to review our infectious disease diagnostics product line.

How Manufacturers Can Prepare for ERPD Submission

For manufacturers whose products are not yet ERPD-listed but who wish to compete in the public health dengue diagnostics procurement channel, here is a practical roadmap based on the ERPD evaluation criteria I have reviewed:

Complete your technical file by analyte. Ensure that your technical documentation includes individual sensitivity and specificity data for each analyte — NS1 separately from IgG/IgM. Aggregate performance claims will not satisfy the ERPD evaluators.

Update your stability documentation. If your accelerated stability studies were conducted at 2–8°C, conduct additional studies at 30°C and 40°C to demonstrate tropical stability. The ERPD expects evidence that the product can maintain performance specifications under the environmental conditions where it will be deployed.

Verify your quality certifications. Ensure that your ISO 13485 certificate is current and covers the specific manufacturing site where the dengue test is produced. MDSAP certification provides additional credibility but is not yet a mandatory requirement.

Align your IFU with WHO guidelines. The WHO published updated dengue diagnostic guidelines in 2024. Your product’s instructions for use should reference compatible testing algorithms, specimen collection procedures, and result interpretation criteria.

Engage with a regulatory consultancy experienced in WHO pathways. The ERPD submission process is distinct from both CE marking and WHO prequalification. Manufacturers who attempt to navigate it without experienced regulatory support may miss documentation requirements or fail to present their data in the format that ERPD evaluators expect. A regulatory consultant who has managed WHO-related diagnostic submissions can help structure the technical file for the specific format required by the ERPD evaluation process. Manufacturers who invest in preparing a comprehensive ERPD-aligned technical file are not just preparing for a single evaluation round — they are building documentation infrastructure that will support multiple regulatory submissions, including WHO prequalification and national-level registrations in multiple countries, over the product lifecycle.

Invest in clinical studies conducted in dengue-endemic populations. Laboratory evaluation studies using spiked samples provide useful analytical performance data, but ERPD evaluators give greater weight to clinical studies conducted in the intended-use population — patients presenting with acute febrile illness in dengue-endemic settings. Manufacturers who have invested in clinical studies in Latin America or Southeast Asia have a documentation advantage over those relying on laboratory-derived performance data alone.

Maintain ongoing dialogue with the WHO prequalification program. The ERPD is a time-limited emergency mechanism (one-year evaluation validity), but the WHO prequalification program provides a longer-term pathway for diagnostic product evaluation. Manufacturers who have an active prequalification submission in progress should coordinate their ERPD submission timeline with their prequalification pathway to ensure consistency in the evidence package.

Prepare a regulatory submission package. The ERPD submission process requires: CE certificate, ISO 13485 certificate, product specification sheet, IFU, clinical study reports (by analyte), stability study data, manufacturing flow diagram, and a declaration of conformity. Preparing this package in advance of a formal submission round significantly accelerates the evaluation timeline.

Conclusion

The WHO’s activation of the ERPD for dengue diagnostics in May 2025 marked a turning point in how dengue rapid tests are evaluated and procured by public health programs worldwide. For procurement officers, the ERPD provides a transparent, evidence-based framework for supplier evaluation that reduces the risk of selecting products with inadequate performance or insufficient quality documentation. For manufacturers, the ERPD criteria represent the new baseline for public health market access — and the evaluation framework provides a clear roadmap for product and documentation improvement.

At Testsealabs, we are actively aligning our dengue combo test with the ERPD evaluation framework. Our product already meets the four evaluation pillars in terms of clinical performance, quality certifications, stability specifications, and alignment with WHO guidelines. We are preparing our technical file for ERPD submission in the next evaluation cycle. For distributors and procurement agencies evaluating our products in the meantime, we provide the same level of documentation transparency that the ERPD requires — individual-analyte performance data, current ISO 13485 and MDSAP certification evidence, and comprehensive stability documentation.

If you are a ministry of health procurement officer or a distributor preparing a dengue test tender, I welcome the opportunity to discuss how our dengue diagnostics product line and technical documentation can support your evaluation process.

For authoritative information on the WHO ERPD and its evaluation framework, I recommend reviewing the WHO’s official Dengue Expert Review Panel for Diagnostics announcement.

About the Author

Angela Qin is the International Sales Director at Hangzhou Testsea Biotechnology Co., Ltd. (Testsealabs), with 10+ years of experience in the IVD industry. Testsealabs is an ISO 13485 and MDSAP-certified manufacturer of rapid diagnostic products for infectious diseases, cardiovascular markers, drug abuse testing, and pregnancy. Founded in 2015, the company’s dengue NS1+IgG/IgM combo test is CE-marked, room-temperature stable, and supported by comprehensive technical documentation.

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