World Health Organization · 1st edition, 2026 · 38 pages
Generic TPP defining acceptable and desirable characteristics for IVD development targeting LMIC health systems across four service-delivery levels.
- Issuer
- World Health Organization
- Edition
- 1st edition, 2026
- Audience
- IVD manufacturers, R&D funders, regulators, national diagnostic programme managers
- Evidence
- Expert consensus through Delphi process; systematic review of 20+ existing disease-specific TPPs
- Reviewed
- 16 Oct 2026 · GMJ
What this guideline says
GMJ summary
This WHO target product profile establishes comprehensive, generic design specifications for in vitro diagnostic (IVD) manufacturers developing tests for low- and middle-income countries. It addresses a critical gap: diagnostic tools are often designed for high-income settings, requiring infrastructure unavailable in resource-limited contexts where diagnostic access remains most limited.
The document provides four separate TPPs tailored to health system levels: instrument-free disposable tests for primary care facilities (levels 0 and 1), self-tests, instrument-based point-of-care tests for peripheral facilities, and laboratory-based tests for facilities with clinical laboratories (levels 2–4). Each TPP specifies both acceptable and desirable characteristics across operational requirements, test performance, data connectivity, biosafety, and pricing.
Key design priorities include: operating at 10–40°C with ≤75% humidity; shelf-life ≥18 months without refrigeration; minimal user steps (≤3 for primary care, ≤2 desirable); invalid/error rates <5% for point-of-care and <3% for laboratory tests; internal quality controls; and connectivity capabilities supporting national data systems. The TPP intentionally omits disease-specific parameters (sensitivity, specificity, analyte) to serve as a foundation for programme-specific TPPs.
Key points
For clinicians — doses and thresholds as stated in the guideline
- Instrument-free tests for primary care: operate 15–35°C (desirable 10–45°C), shelf-life 18 months at 10–40°C, ≤3 user steps with ≤1 precision step, result in <1 hour (desirable <20 minutes), invalid rate <5%
- Self-tests: ≤3 user steps (desirable ≤2), no precision measurements, result <1 hour, invalid rate <5%, instructions with image-based guidance and online audiovisual support
- Point-of-care instrument-based tests: ≤3 user steps, result <1 hour, throughput 3–5 tests/hour, invalid/error rate <8% (desirable ≤5%), battery/solar power >6 hours, USB and Wi-Fi connectivity
- Laboratory-based tests (levels 2–4): ≤10 user steps with ≤5 timed, result <8 hours (desirable <2 hours), throughput >100 tests/8-hour shift, invalid rate ≤3% (desirable ≤1%)
- All test formats: biosafety requiring only universal precautions, waste disposal in biosafety bins, compliance with ISO 13485 quality management, WHO prequalification when available
- Temperature stability requirements: most tests 18 months at 10–40°C with ≤70% humidity (desirable >24 months at 4–40°C with ≤75% humidity), meeting ASTM D4169-05 transport standards
- Data requirements: secure end-to-end encryption, CSV and Excel export formats, DHCP and HTTPs support, privacy-by-design aligned with OECD guidelines and ISO/IEC 27701
- Pricing targets: rapid tests ideally <US$1 (HIV professional RDTs US$0.30–0.90, malaria US$0.19–0.28), self-tests US$1–3, point-of-care molecular tests vary widely (TB <US$4, HIV viral load ~US$27 at time of publication)
Key operational requirements across four IVD target product profiles
Table extracted from the guideline
| Characteristic | Level 0–1 Instrument-free | Self-test | Level 0–1 POC instrument | Level 2–4 Laboratory |
|---|---|---|---|---|
| Operating temp (desirable) | 10–45°C | 10–45°C | 10–45°C | 10–40°C |
| Shelf stability (desirable) | >24 mo, 4–40°C | >24 mo, 4–40°C | >24 mo, 4–40°C | 24 mo, 4–40°C |
| User steps (desirable) | ≤2 | ≤2 | ≤2 | ≤10 (≤5 timed) |
| Time to result (desirable) | <20 min | <20 min | <20 min | <2 hours |
| Invalid rate (desirable) | <2% | <2% | ≤5% | ≤1% |
| Power required | None | None | Battery >6 hr | Mains + UPS |
| Connectivity | Optional reader | Optional reader | USB, Wi-Fi, GPS | USB, Wi-Fi, LAN |
Source: World Health Organization, Target Product Profile – Developing In Vitro Diagnostics for Low- and Middle-Income Settings. Reproduced in summary form.
From the guideline
Verbatim
“The 2021 Lancet Commission on Diagnostics found that nearly 50% of the global population have little to no access to IVDs.”
Editor’s perspective
Why this matters for Georgia and the region
Prof. Giorgi Pkhakadze, MD, MPH, PhD
Editor-in-Chief, Georgian Medical Journal · Chair, Public Health Institute of Georgia · WHO consultant, health and migration
This target product profile addresses a fundamental challenge we face across the South Caucasus: diagnostic tools designed for Western European or North American laboratories often arrive with specifications incompatible with our infrastructure realities—cold-chain requirements our peripheral facilities cannot sustain, software that assumes reliable broadband, instruments calibrated for sea-level laboratories when much of Georgia sits at 1,500 metres elevation. Having contributed to WHO diagnostic guidance development, I would stress to Georgian colleagues the operating temperature specifications (10–45°C desirable) and the connectivity standards requiring offline functionality with batch data upload—these directly address our rural clinic conditions. The critical implementation caveat for Georgia is that while this TPP provides excellent manufacturer guidance, our national procurement specifications must still verify actual performance under Georgian conditions: a test meeting the 18-month stability claim at 10–40°C must demonstrate that stability through our Caucasus summers in non-air-conditioned health posts, not just in controlled warehouse studies. Our National Centre for Disease Control should pilot-test shortlisted products under real Georgian field conditions before national rollout, as we learned during the GeneXpert scale-up for TB diagnosis.
ORCID 0000-0001-7609-4515 · Perspective written for the GMJ Guidelines Library, 16 Oct 2026
Applicability
Georgia and the South Caucasus
This TPP is directly relevant for Georgia’s diagnostic system modernization and addresses challenges faced across the South Caucasus. Georgia’s national disease programmes (TB, HIV, hepatitis C elimination) rely on diagnostic networks spanning primary care to reference laboratories. Implementation considerations include: adapting temperature specifications for highland regions (altitude >1000 m common in Georgia, Armenia); ensuring connectivity solutions function with existing GSM networks (2G/3G remain common in rural areas); aligning data privacy requirements with Georgian personal data protection law; and incorporating reagent stability requirements into national procurement specifications. The TPP’s tiered approach matches Georgia’s three-level laboratory system (L1 peripheral, L2 regional, L3 national reference). Pricing targets require contextualization: while the TPP cites Global Fund prices, Georgian procurement through bilateral agreements may differ. National programmes should use this TPP when developing technical specifications for tenders and when evaluating manufacturer proposals for new diagnostic platforms.
Questions this guideline answers
Quick answers
What is the difference between 'acceptable' and 'desirable' characteristics in this TPP?
Acceptable characteristics represent the minimum satisfactory requirements for a product to be considered viable for LMIC settings. Desirable characteristics are aspirational but realistically achievable targets that would provide greater impact for end-users and patients. Products should meet all acceptable characteristics and strive to achieve as many desirable characteristics as possible, though pursuit of perfection should not unnecessarily delay development.
Why are there four separate target product profiles in this document?
The four TPPs reflect distinct infrastructural realities across LMIC health systems: instrument-free tests for primary care facilities without laboratories (level 0–1), self-tests for home/community use, instrument-based point-of-care tests for peripheral facilities, and laboratory-based tests for facilities with clinical laboratories (levels 2–4). Each setting has different power availability, personnel training, throughput needs, and connectivity capabilities requiring tailored specifications.
What disease-specific parameters should be added when using this generic TPP?
Disease-specific TPPs must add: intended use (screening, diagnosis, monitoring, surveillance), target population, analyte(s) detected, specimen type and volume, analytical sensitivity/limit of detection, analytical specificity including cross-reactivity, clinical sensitivity and specificity, reference test, and whether results are quantitative, semi-quantitative, or qualitative. Operating temperature and humidity ranges may also require adjustment based on disease geography.
Why does the point-of-care TPP allow higher invalid rates (8%) than laboratory tests (3%)?
Point-of-care instruments are complex technologies operated by non-laboratory personnel in challenging conditions. Higher acceptable invalid rates (8% acceptable, 5% desirable) reflect the trade-off of including robust internal quality controls that flag problems rather than reporting false results. Laboratory-based tests performed by trained professionals with quality assurance programmes should achieve lower invalid rates (3% acceptable, 1% desirable). Both targets are based on published LMIC implementation data.
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- Issuer
- World Health Organization
- Type
- Standards
- Edition
- 1st edition, 2026
- Status
- Current
- Published
- 2026-07-20
- Languages
- English
- Scope
- Generic specifications for IVD development for LMICs; excludes disease-specific parameters
- Audience
- IVD manufacturers, R&D funders, regulators, national diagnostic programme managers
- Pages
- 38
- Licence
- CC BY-NC-SA 3.0 IGO
- ISBN
- 978-92-4-012315-1
- Evidence
- Expert consensus through Delphi process; systematic review of 20+ existing disease-specific TPPs
- Next review
- At least every 5 years or when science/epidemiology changes
- Record history
- Created 16 Oct 2026 · updated 16 Oct 2026 · next check Apr 2027
Target product profile – developing in vitro diagnostics for low- and middle-income settings. Geneva: World Health Organization; 2026. Licence: CC BY-NC-SA 3.0 IGO.GMJ Guidelines Library records are original summaries written by the GMJ editorial team from the issuer’s published document and reviewed by a physician. They do not replace the full guideline. The document is the copyright of its issuer and is linked, not hosted. Spotted an error or a newer edition? Tell the Guidelines Desk.
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