Target product profiles

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
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. TPP 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. TPP 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

 

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?
(preprint, yet to be peer-reviewed)
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
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. Target Product Profile: 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
BURULI ULCER: CASE CONFIRMATION TO ENSURE RAPID TREATMENT
An RDT that detects M. ulcerans antigens in less invasive samples, that can be used at the community and primary health care level for early detection of cases and confirmation of M. ulcerans infection. DRAFTING IN PROCESS
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: ASSESSMENT OF RESPONSE TO TREATMENT (TEST OF CURE)
A test to assess anti-T. cruzi treatment response in Chagas disease patients. The test should allow assessing cure faster than seroconversion to improve case management at the district hospital level. Target Product Profile (TPP) for Chagas Disease Point-of-Care Diagnosis and Assessment of Response to Treatment
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
LEISHMANIASIS: ASYMPTOMATIC LEISHMANIA INFECTION OR LEISHMANIA EXPOSURE ASSESSMENT
A test that can detect Leishmania asymptomatic infection, as well as Leishmania exposure, ideally in decentralized health care facilities with no laboratory infrastructure. DRAFTING IN PROCESS
LEISHMANIASIS: POINT-OF-CARE TEST FOR VISCERAL LEISHMANIASIS (VL) DIAGNOSIS AND TREATMENT MONITORING
A test that detects Leishmania antigen in less invasive samples to be used as an indicator of actual infection and both for diagnosis and as a test of cure. It should detect the actual Leishmania burden in VL patients and be applied ideally in decentralized health care facilities with no laboratory infrastructure. DRAFTING IN PROCESS

 

Pandemic Preparedness

NEED TARGET PRODUCT PROFILE
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. IN REVIEW
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
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
A TEST OF CURE AND TREATMENT MONITORING TEST
A test that can determine relapse free cure with the purpose of terminating TB treatment (i.e. according to individual response rather than as per current standard regimens duration), ideally using non-sputum samples. DRAFTING IN PROGRESS
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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