Target product profiles
Target product profiles (TPPs) provide details on the minimum and optimal performance and operational characteristics of priority diagnostic tests. Researchers, developers, and manufacturers use TPPs to ensure that R&D activities are focused on relevant products and designed for the contexts and needs of end-users.
FIND plays an important coordinating role in the development of consensus-based TPPs for diagnostic tools for poverty-related diseases. We engage and convene stakeholders, including researchers, developers, disease specialists, and end-users, to prioritize unmet diagnostic needs and to identify, discuss and agree on the desired characteristics of priority tests.
If you can help meet the TPP specifications for needed tests for diseases in our portfolio, please submit your solution for technology review.
Antimicrobial Resistance
| NEED | TARGET PRODUCT PROFILE |
| DIAGNOSTICS TO DETECT ANTIBACTERIAL RESISTANCE | |
| Due to the increasing prevalence of antimicrobial resistance, there is a need to stimulate the development of, and access to, appropriate rapid diagnostic tools for bacterial pathogen identification as well as antimicrobial susceptibility testing at all levels of the healthcare system in low- and middle-income countries. | Target product profiles for antibacterial resistance diagnostics
Technical consultation on in vitro diagnostics for AMR Landscape of diagnostics against antibacterial resistance, gaps and priorities |
| A TEST TO IDENTIFY GONORRHOEA RESISTANCE TO ANTIBIOTICS | |
| Neisseria gonorrhoeae (NG) infection is the second most common STI worldwide, with substantial morbidity and economic cost. WHO has identified NG as a high-priority pathogen because of widespread antimicrobial resistance to existing antibiotics. Syndromic case management continues to be used in low-and middle-income countries due to the lack of appropriate diagnostic tools. | Target product profile for a test to identify susceptibility/resistance of gonorrhoea to antibiotics to facilitate antibiotic stewardship |
| A TEST TO DISTINGUISH GONORRHOEA FROM CHLAMYDIA INFECTION AT PRIMARY CARE | |
| Chlamydia trachomatis (CT) is the world’s most prevalent STI. Overuse of antibiotics contributes to rising rates in AMR. The stewardship strategy for antibiotic use must fit within a redefined, WHO-supported clinical algorithm that includes the use of diagnostics for patients presenting in primary health care settings. A test to identify previously undetected NG or NG and CT infections will dramatically improve treatment decisions and reduce AMR. | Target product profile for a rapid, low-cost diagnostic to distinguish gonorrhoea from Chlamydia infection at primary care |
| SIMPLIFIED BLOOD CULTURE | |
| A simplified blood culture system that meets a subset of the characteristics defined in the TPP and is designed with the procurement and capacity challenges of resource-limited settings in mind would enable expanded use of blood culture in these regions. | Defining system requirements for simplified blood culture to enable widespread use in resource-limited settings |
| BACTERIAL VERSUS NON-BACTERIAL DIFFERENTIATION FOR FEVER | |
| Rapid, biomarker-based tests that can differentiate bacterial from non-bacterial infections to guide appropriate treatment and reduce the spread of antimicrobial resistance. | Target product profile for a diagnostic assay to differentiate between bacterial and non-bacterial infections and reduce antimicrobial overuse in resource-limited settings: An expert consensus |
Digital health
| NEED | TARGET PRODUCT PROFILE |
| READERS OF RAPID DIAGNOSTIC TESTS | |
| Companion tools for rapid diagnostic tests (RDTs) such as mobile applications/readers could aide more consistent, accurate use of these widely used tests for malaria, HIV, COVID-19, and more. These RDT readers may take the form of dedicated instruments or apps on mobile phones and tablets, whether for professional use or self-testing, and whether as an aid to clinical diagnosis or a non-clinical data capture tool. With the World Health Organization (WHO), we are now seeking feedback on this target product profile (TPP) aimed at guiding the development of fit-for-purpose readers from experts. | Call for public consultation – Target Product Profile (TPP) for readers of rapid diagnostic tests (RDT readers) |
| MOBILE APP TO READ RDTs TO STRENGTHEN DISEASE SURVEILLANCE | |
| The essential role of rapid diagnostic tests in disease control is compromised every time a test is not performed correctly or its result is not reported accurately and promptly. A mobile app that utilizes the camera and connectivity of a common smartphone can fill this role of supporting the test’s proper execution and the automatic transmission of results. | Target Product Profile for a mobile app to read rapid diagnostic tests to strengthen infectious disease surveillance |
| CLINICAL DECISION SUPPORT ALGORITHMS INCORPORATING POINT-OF-CARE DIAGNOSTIC TESTS IN LMICs | |
| A toolkit composed of electronic clinical decision support algorithms and point of care diagnostics designed for resource-constraint settings to optimize the use of resources, contextual information and diagnostic results to provide evidence-based preventative and curative recommendations at the point of care to improve patient management and health outcomes. | Electronic clinical decision support algorithms incorporating point-of-care diagnostic tests in low-resource settings: a target product profile |
Hepatitis C & HIV
| NEED | TARGET PRODUCT PROFILE |
| HEPATITIS C DIAGNOSIS IN DECENTRALIZED SETTINGS | |
| A core antigen or molecular test that can diagnose active viraemic HCV infection (new or reinfection) and provide baseline virological assessment; and confirm cure upon completion. Ideally, the test would be rapid, allowing same-day treatment initiation. | High-priority target product profile for hepatitis C diagnosis in decentralized settings: Report of a consensus meeting |
| HIV RECENT INFECTION TEST | |
| A test that can be used in a wide variety of contexts to determine recent HIV infection, that would be usable without supplemental tests, and that would need reduced samples size compared with existing tests. | Target Product Profile for tests for recent HIV infection |
Malaria & Fever
| NEED | TARGET PRODUCT PROFILE |
| A NEXT-GENERATION POINT-OF-CARE TEST FOR TYPHOID FEVER | |
| Typhoid fever is one of the most common bacterial causes of acute febrile illness in the developing world, with an estimated 10.9 million new cases and 116.8 thousand deaths in 2017. Current point-of-care rapid diagnostic tests (RDTs) are widely used but have poor sensitivity and specificity, resulting in antibiotic overuse. To reduce the empiric use of antibiotics, a next-generation typhoid RDT would ideally be combined with diagnostics for malaria and other causes of acute febrile illness. | Redefining typhoid diagnosis: what would an improved test need to look like? |
| A MULTIPLEX MULTI-ANALYTE DIAGNOSTIC PLATFORM (MAPDx) | |
| The problem of severe febrile illness has led MSF, FIND and WHO to call for the development of a multiplex, multi-analyte diagnostic platform comprising of an instrument with assay cartridges designed to detect a broad range of pathogens, including HIV, TB, and malaria, as well as assays for non-communicable diseases, such as diabetes. | — A multiplex, multi-analyte diagnostic platform
— Multiplex-Multi-Analyte Febrile Illness Test for use on the MAPDx platform |
| MOLECULAR ASSAYS FOR ANTIMALARIAL DRUG RESISTANCE SURVEILLANCE | |
| There is a need to strengthen surveillance systems for early detection and response to the antimalarial drug resistance threat. Here we identify the requirements for an ideal product that would allow malaria-endemic countries to provide useful spatial and temporal information on the spread of resistance. | Molecular assays for antimalarial drug resistance surveillance: A target product profile |
| Pf: POINT-OF-CARE DIAGNOSIS OF SUBPATENT PLASMODIUM FALCIPARUM INFECTION | |
| An infection detection test for qualitative detection of Plasmodium falciparum infections, which can be used in active infection detection interventions aimed at identifying and treating subclinical, low parasite density-infected populations. The proposed test will use a finger-prick blood sample. | Point-of-care malaria infection detection test for rapid detection of low-density, subclinical malaria infections |
| PvA: DIAGNOSIS OF PLASMODIUM VIVAX MALARIA ACUTE DISEASE | |
| This TPP addresses the need for tests for the parasitological confirmation of suspected symptomatic episodes of P. vivax malaria to guide the management of clinical cases. Therefore, the test needs to accurately detect biologically active erythrocytic forms of P. vivax. | PvA: Diagnosis of Plasmodium vivax malaria acute infection |
| PVB1: POINT-OF-CARE DIAGNOSIS OF SUBPATENT PLASMODIUM VIVAX INFECTION | |
| This TPP addresses the need for infection detection tests for P. vivax able to detect a substantial fraction of all infections (symptomatic or asymptomatic) for screen-and-treat in any active infection detection interventions. Therefore, the test needs to accurately detect low-density erythrocytic forms of P. vivax in a point-of-care manner. | PvB1: Point-of-care diagnosis of subpatent Plasmodium vivax infection |
| PVB2: POPULATION SCREENING FOR PLASMODIUM VIVAX INFECTION SURVEILLANCE | |
| This TPP addresses the need for an indication of current or recent P. vivax infection for epidemiological surveys and surveillance activities not necessarily linked with direct treatment of positive cases. Therefore, the test needs to accurately detect biomarkers of recent infection or low-density erythrocytic forms of P. vivax with high throughput and analytical sensitivity. | PvB2: Population screening for Plasmodium vivax infection surveillance |
Neglected Tropical Diseases
| NEED | TARGET PRODUCT PROFILE |
| BURULI ULCER: POINT-OF-CARE SCREENING TEST | |
| A test that requires neither sophisticated equipment nor technical expertise to confirm Buruli Ulcer in symptomatic patients at the district hospital level. | Report of a WHO-FIND meeting on diagnostics for Buruli ulcer |
| CHAGAS: POINT-OF-CARE TEST FOR CONGENITAL CHAGAS DISEASE | |
| A sensitive test that can detect T. cruzi infection in newborns in the first days of life and that can be performed at the point-of-care. The test could also be used to diagnose other forms of acute Chagas disease (e.g. vector or oral transmission). | Target Product Profile (TPP) for Chagas disease point-of-care diagnosis and assessment of response to treatment |
| CHAGAS: EARLY ASSESSMENT OF TREATMENT EFFICACY IN CHAGAS DISEASE PATIENTS | |
| A test that can determine in a timely manner if a patient treated for Chagas disease has successfully responded to treatment. Such a test could be used (1) in the daily clinical management of Chagas disease patients post treatment to decide if and/or when a patient should be followed up after treatment completion, and (2) in the context of clinical trials (CT), where the test would be used as the endpoint measurement for the evaluation of new anti–T. cruzi treatments. | Target Product Profile (TPP) for a test for the early assessment of treatment efficacy in Chagas disease patients: An expert consensus |
| HAT: SCREENING FOR EARLY DETECTION | |
| A highly accurate and easy to use test to detect HAT suspects, which can be used at all levels of the health system, including in decentralized facilities with no laboratory infrastructure. | Target Product Profile: Screening test for human African trypanosomiasis (HAT) |
| HAT: RAPID TEST FOR SIMULTANEOUS DETECTION OF HAT AND MALARIA | |
| A highly accurate and easy to use test to simultaneously detect HAT suspects and malaria infection. | Target Product Profile: Rapid test for diagnosis of malaria and screening for human African trypanosomiasis (HAT) |
| LEISHMANIASIS: POINT-OF-CARE TEST FOR CUTANEOUS LEISHMANIASIS (CL) | |
| A rapid, simple test to be used in the point-of-care diagnosis of the different forms of CL, including localized CL (LCL), mucocutaneous leishmaniasis (MCL), diffuse cutaneous leishmaniasis (DCL), and cutaneous leishmaniasis recidivans (CLR). Also applicable to PKDL. To be applied ideally in decentralized health care facilities with no laboratory infrastructure. | Target Product Profile for a point-of-care diagnostic test for dermal leishmaniases |
Non-communicable diseases
| NEED | TARGET PRODUCT PROFILE |
| POINT-OF-CARE CARDIOMETABOLIC DEVICE | |
| There is a demonstrated need to develop and adopt affordable and effective point-of-care (POC) diagnostic tools that are suitable for use in low-resource primary care settings to improve diagnosis and management of cardiometabolic disease. Here, we describe the development of a TPP for a POC multi-parameter device to measure cardiometabolic biomarkers at primary care. | Development of a target product profile for a point-of-care cardiometabolic device BMC Cardiovasc. Disord., Vetter B, et al. Oct 2021
Target Product Profile for a point-of-care cardiometabolic device (Report) |
Pandemic Preparedness
| NEED | TARGET PRODUCT PROFILE |
| COVID-19 TPP FOR PRIORITY DIAGNOSTICS TO SUPPORT RESPONSE TO THE COVID-19 PANDEMIC | |
FIND contributed to the WHO target product profiles (TPPs) for priority COVID-19 diagnostics. They describe the desirable and minimally acceptable profiles for four tests:
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These TPPs will be reviewed and updated as new information becomes available. |
| LASSA FEVER INFECTION TESTS | |
| Near-patient tests, or diagnostic tests applicable at point-of-care, especially those with the ability to detect all lineages of Lassa fever to allow for rapid detection in resource-limited health facilities closer to the patient.
Accompanying paper: https://gh.bmj.com/content/4/Suppl_2/e001119 |
IN REVIEW |
| NEAR-PATIENT MOLECULAR DIAGNOSTIC PLATFORM FOR EPIDEMIC-PRONE PATHOGENS | |
| A comprehensive, near-patient molecular diagnostic testing platform (NPT-MDx) that can accommodate an array of assays to identify pathogens for outbreak response, hospital triage, and individual patient management in level 2 healthcare facilities. | An open-source molecular diagnostic platform approach for outbreak and epidemic preparedness |
| YELLOW FEVER INFECTION TESTS | |
| In recent years, hundreds of thousands of yellow fever (YF) cases and related deaths were reported in Eastern and Southern Africa as well as in South America. Currently, only national and regional reference labs have the diagnostic capacity to confirm YF. These target product profiles were developed in partnership with Gavi and WHO to define improvements needed to support testing both at the national and regional reference labs and to support further decentralized testing. | TPPs for identification of yellow fever infections |
| EBOLA RAPID TESTS FOR EARLY DETECTION | |
| New rapid, point of contact/care tests to be used in decentralized health care facilities and not requiring extensive biosafety requirements. | Target Product Profile for Zaïre ebolavirus rapid, simple test to be used in the control of the Ebola outbreak in West Africa |
Tuberculosis
| NEED | TARGET PRODUCT PROFILE |
| NEXT-GENERATION TB DST AT PERIPHERAL CENTRES | |
| This updated TPP is intended to specify desirable attributes of next-generation drug-susceptibility testing for M. tuberculosis and align the development of new interventions with evolving gaps and the needs of individuals and populations. | Target product profile for next-generation tuberculosis drug-susceptibility testing at peripheral centres |
| TRIAGE TEST | |
| A point-of-care triage test to rule out TB, which should be a simple, low-cost test that can be used by first-contact health-care providers to identify those who need further testing. | High-priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting |
| POINT-OF-CARE NON-SPUTUM BIOMARKER TEST | |
| A rapid, point-of-care, non-sputum-based test capable of detecting all forms of TB by identifying characteristic biomarkers or bio-signatures. Such a diagnostic test would be implemented at microscopy centers of below and should be easy to perform, robust with very simple (or no) sample preparation and minimal operational requirements. | High-priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting |
| SMEAR REPLACEMENT TEST | |
| A more sensitive point-of-care sputum-based test to replace smear microscopy for detecting pulmonary TB that is easy to perform and has limited operational requirements. | High-priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting |
| NEXT GENERATION DRUG-SUSCEPTIBILITY TEST TO INFORM TREATMENT | |
| A rapid drug-susceptibility test that can be used at the microscopy-center level of the health-care system to select regimen-based therapy. Such a novel diagnostic test should ideally include testing for, in order of importance: rifampicin, fluoroquinolones, pyrazinamide, and isoniazid. | High-priority target product profiles for new tuberculosis diagnostics: report of a consensus meeting |
| NGS FOR DETECTION OF RESISTANCE-ASSOCIATED MUTATIONS IN MYCOBACTERIUM TB COMPLEX | |
| In the short-term, the assay will provide support for the identification of optimal, individualized TB regimen and/or drug selection for treatment at the reference center level. In the longer term, the assay will provide support for guiding effective first-line TB therapy. It can also be used for culture-free surveillance of drug-resistant TB. | Detection of resistance-associated mutations in Mycobacterium tuberculosis complex utilizing next-generation sequencing |
| A TEST FOR DETECTION OF DISEASE PROGRESSION | |
| An ideal test of TB disease progression would differentiate patients in the various stages from infection to active TB, and may detect the presence or absence of incipient TB (defined as the prolonged asymptomatic phase of early disease during which pathology evolves, prior to the clinical presentation of active disease). | Development of a Target Product Profile (TPP) and a framework for evaluation for a test for predicting progression from tuberculosis infection to active disease |
| SAMPLE TRANSPORT SOLUTION | |
| A solution that (i) is compatible with liquid and solid culture methods as well as molecular methods for MTBC detection; (ii) helps maintain MTBC viability; (iii) reduces the risk of contamination, (iv) potentially liquefies the sample; and (v) ideally requires less hands-on time, technical skill and that can be harmonized with local laboratory conditions. | Commercial products for preserving clinical specimens for the diagnosis of tuberculosis |
| DIGITAL HEALTH PRODUCTS | |
| Diagnostic test devices to support “connectivity”, tailored to the needs of centralized and decentralized testing in low- and middle-income countries. This also requires diagnostic systems that are able to report test results directly (via well-described protocols) to data server(s) for use by applications or entities that consume the data. | Target product profiles for digital health products for the End TB Strategy |
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