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. FIND engages and convenes 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.
Tech scouting: can you help meet TPPs?
FIND scouts for innovative diagnostic approaches for addressing the unmet diagnostic needs described in finalized TPPs. For selected promising diagnostic technologies, FIND may provide researchers and developers with support in the development and implementation process. For more information, visit our Technology Scouting & Review page.
Simplified blood culture
Bacterial blood stream infections (BSI) are a common cause of mortality and morbidity globally. As the causative agents and the resulting treatment decisions vary, near-patient testing and surveillance tools are necessary to monitor bacterial causes and resistance to antimicrobial agents. The gold standard to identify BSIs is blood culture (BC), a methodology not widely available in resource-limited settings.
Faster and more accurate diagnosis of bloodstream infections in low-resource areas is critical for effective patient management, surveillance of AMR, and development of local empiric therapy guidelines. A simplified BC 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 BCs in these regions.
A multiplex multi-analyte diagnostic platform (MAPDx)
Fever is one of the most common reasons for admission to hospitals in low-resource settings. Among the millions of patients Médecins Sans Frontières (MSF) sees each year, the problem of patients presenting with severe febrile illness without a known source is all too frequent. Treating these patients poses a significant challenge due to a lack of reliable and comprehensive diagnostics.
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.
Bacterial versus non-bacterial differentiation test for fever
Fever is a symptom of a wide variety of infections, both viral and bacterial. In developing countries, patients seeking treatment for acute fever at the community level are often given antibiotics, particularly in malaria endemic areas, even though their fever is caused by a virus. This negatively affects patient outcomes and increases antimicrobial resistance.
Rapid, biomarker-based testing to differentiate bacterial from non-bacterial infections to guide appropriate treatment and reduce spread of antimicrobial resistance.
Ebola rapid tests for early detection
One of the major challenges that presented itself in the 2014-2015 Ebola virus disease (EVD) outbreak in West Africa was the limited diagnostic capacity of affected countries. Diagnosis relied on mobile laboratory units and other designated laboratories to run molecular assays to confirm EVD. This centralized testing approach resulted in significant delays in sample testing. Paired with the lack of proven interventions (treatment and vaccines), rapid, accurate identification and isolated management of EVD cases were recognized as fundamental to interrupting disease transmission, and bringing the outbreak under control.
New rapid, point of contact/care tests to be used in decentralized health care facilities and not requiring extensive biosafety requirements.
The use of diagnostic test devices has increased in developing country labs and health facilities. However, obstacles remain that limit the potential health impact of the tests being used.
Diagnostics that leverage connectivity—where data are sent from diagnostic devices to data repositories and management systems, such as electronic medical records, laboratory management systems and others—result in better data flow and sharing of test results, and faster and more appropriate linkages to treatment and care for patients.
Diagnostic test devices to support “connectivity”, tailored to the needs of centralised and decentralised 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.
Diagnostic data aggregation
Systems to collect and store data from diagnostics devices have typically been developed by diagnostic manufacturers without consideration of other instruments by different manufacturers used in the same facility or network of facilities. Systems are often closed and do not support open data sharing with other systems.
Systems for centralized but local, secure aggregation and flexible management of data from multiple diagnostics regardless of manufacturer. A comprehensive Application Programming Interface for routing of data to existing health and management applications. Systems suitable for deployment in low resource settings.
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Diagnostic data analytics and management
Systems that visualize and report data from connected diagnostics often do so with narrow focus on particular device types that report data and disease. Systems are often `hardcoded’ and inflexible and do not fulfil the exact requirements of the users.
- Allow the flexible and customizable reporting of data for multiple diseases and from multiple devices
- Work across a network of locations and for different stakeholders needs
- Are suitable for low bandwidth (bit rate) settings
- Are intuitive and easy to use
- Support multiple languages
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Hepatitis C diagnosis in decentralized settings (core antigen or molecular test)
A lack of effective diagnostics is one of the major barriers to providing life-saving care and treatment for hepatitis C. Less than 1% of people with hepatitis C in low- and middle-income countries are aware of their infection. Existing tests are costly and complex, requiring sophisticated infrastructure.
A 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.
HIV Recent infection test
The WHO released new guidelines in 2015 stating that incidence should be used as a key indicator for evaluating the impact of HIV programs. Typically, estimating HIV incidence is a major challenge and often relies on modelling rather than measuring.
Laboratory-based biological assays that can determine whether an HIV infection was contracted within the previous year present a better, alternative approach to estimating incidence. Some such tests have been developed—though they can only be used in select, high prevalence and incidence settings—and others are forthcoming
A test that can be used in a wide variety of contexts to determine recent infection. Ideal test would be usable without supplemental tests and with a reduced samples size vis a vis existing tests.
Molecular assays for antimalarial drug resistance surveillance: A target product profile
Antimalarial drug resistance is a major constraint for malaria control and elimination efforts. For multiple common antimalarials, parasite drug resistance has been correlated with specific genetic mutations, and the molecular markers associated with antimalarial drug resistance offer a simple and powerful tool to monitor the emergence and spread of resistant parasites.
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.
Pf: Point-of-care diagnosis of subpatent Plasmodium falciparum infection
The epidemiology of malaria changes significantly as regions transition from control to pre-elimination phase prevalence levels. In low-prevalence regions, a larger proportion of ongoing transmission is attributed to low density and subclinical infections that are not easily detected by RDTs or microscopy. As such, active infection detection tactics and more accurate diagnostic tools are needed.
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 used a finger-prick blood sample.
PvA: Diagnosis of Plasmodium vivax malaria acute disease
Plasmodium vivax is the most geographically widespread malaria species and is causing approximately half of the malaria cases outside of Africa. Acute Plasmodium vivax infections are challenging to diagnose due to low pyrogenic threshold and circulating parasite densities. Improved tests are needed to facilitate the rapid and accurate diagnosis of this malaria species in febrile individuals.
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.
PvB1: Point-of-care diagnosis of subpatent Plasmodium vivax infection
Asymptomatic Plasmodium vivax infections are common in all endemicity settings and represent a significant contribution to disease transmission. Despite the absence of symptoms, these infections need to be identified and treated to accelerate elimination of this Plasmodium species.
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.
PvB2: Population screening for Plasmodium vivax infection surveillance
Plasmodium vivax s the predominant malaria species in a majority of the countries on the road to elimination. Targeted interventions must be based on accurate surveillance data, which become more and more difficult to generate as prevalence decreases. Innovative solutions are needed to enable effective surveillance and interventions strategies.
This TPP addresses the need for indication of current or recent P. vivax infection for epidemiological surveys and surveillance activities not necessarily linked with a 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 a high throughput and analytical sensitivity.
Neglected Tropical Diseases
Buruli ulcer: Point-of-care screening test
PCR/qPCR targeting the IS2404 region is the gold standard in Buruli ulcer diagnosis, however this is only applicable in reference laboratories, which are not close to the patients in endemic foci.
A test that requires neither sophisticated equipment nor technical expertise to confirm Buruli Ulcer in symptomatic patients at the district hospital level.
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Buruli ulcer: Case confirmation to ensure rapid treatment
Early detection and treatment of Buruli ulcer is currently the best approach to control the disease, and is crucial to reduce the disability and morbidity caused by Buruli ulcer.
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.
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Chagas: Point-of-care test for congenital Chagas disease
Currently, microscopy and antibody detection tests are used to diagnose congenital Chagas disease in babies born from T. cruzi infected mothers. Microscopy requires trained personnel and current serological tests can only be carried out 9 months after birth. Thus a large number of congenital Chagas cases are not diagnosed. Treating Chagas disease in babies is safe and effective.
A sensitive test that can detect T. cruzi infection in newborns in the first days of live is needed. The test should be performed at the point-of-care: minimum labs in maternity wards/district hospitals; ideally health posts for.
The test could also be used to diagnose other forms of acute Chagas disease (e.g. vector or oral transmission).
Chagas: Assessment of response to treatment (test of cure)
Treatment of chronic Chagas is lengthy, and drugs often have toxic side effects. Assessing the efficacy of the treatment is difficult and may take a long time; e.g. the gold standard for evaluating efficacy (seroconversion using conventional serological tests) may take years to decades to assess.
There is a lack of consensus regarding therapeutic response markers for early assessment of antitrypanocidal drug efficacy.
A test to assess anti-T. cruzi treatment response Chagas disease patients is needed. The test should allow assessing cure faster than seroconversion to improve case management at district hospital level.
HAT: Screening for early detection
Prior to performing parasitological confirmation, HAT suspects are identified either by active screening of the general population or by passive screening of patients with symptoms suggestive of HAT.
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.
HAT: Rapid test for simultaneous detection of HAT and malaria
HAT endemic regions are also endemic for malaria. As HAT is being eliminated, the index of clinical suspicion of HAT is decreasing and screening is becoming less common. As a result, the remaining HAT cases are increasingly likely to be missed. Taking advantage of testing for malaria to also test for HAT could help detect these remaining HAT cases.
Highly accurate and easy to use test to simultaneously detect HAT suspects and malaria infection.
Leishmaniasis: Point-of-care test for cutaneous leishmaniasis (CL)
Diagnosis of CL is mainly based on microscopy, which lacks sensitivity and is not always accessible at the point of care. Depending on the Leishmania species and clinical presentation systemic treatment is required, as this can be toxic confirmatory diagnosis is required.
Rapid, simple test to be used in the point-of-care diagnosis of the different forms of cutaneous leishmaniasis (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.
Leishmaniasis: Asymptomatic Leishmania infection or Leishmania exposure assessment
Individuals with asymptomatic Leishmania infection are indicators of actual transmission as well as potential sources of infection to sandflies. Asymptomatic infection and infectiousness to sand flies is a key issue in the context of pre- and post-VL elimination.
A test that can detect Leishmania asymptomatic infection, as well as Leishmania exposure, ideally in decentralized health care facilities with no laboratory infrastructure.
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Leishmaniasis: Point-of-care test for visceral leishmaniasis (VL) diagnosis and treatment monitoring
Current RDT based on anti-Leishmania antibodies detection lack sensitivity in eastern Africa and in HIV-co-infected patients. And these cannot be used to diagnose relapses.
A test that detects Leishmania antigen in less invasive samples can be used as an indicator of actual infection and can be used both for diagnosis and test of cure, as it will detect the actual Leishmania burden in VL patients. To be applied ideally in decentralized health care facilities with no laboratory infrastructure.
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Two weeks of cough is a widely used symptomatic indicator to identify individuals with presumed active pulmonary tuberculosis (TB) who require diagnostic testing. Since most individuals with suspected TB do not have TB, a triage test can help narrow down the population that needs the more costly and maybe not as easily accessible confirmatory testing.
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.
Point-of-care non-sputum biomarker test
The majority of pulmonary tuberculosis (TB) cases are diagnosed by sputum smear microscopy. However, smear microscopy has suboptimal sensitivity and children and HIV-infected individuals often have difficulty providing a good quality sputum sample. Molecular methods are more sensitive than sputum smears but cannot be deployed in most microscopy centers.
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.
Smear replacement test
The majority of pulmonary tuberculosis (TB) cases are diagnosed by sputum smear microscopy, which has suboptimal sensitivity. A more sensitive test at the microscopy center level has the potential to improve patient care by (i) reducing transmission by increasing TB diagnosis, linked to treatment and (ii) leveraging existing infrastructure in microscopy centers.
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.
Next generation drug-susceptibility test to inform treatment
The global spread of drug-resistant tuberculosis threatens gains made in TB cure rates. A test that can both detect TB as well as drug resistance against first and second-line drugs employed at lower levels of the health care system (decentralized) can inform care providers which best regimens to prescribe.
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.
Test for detection of disease progression
The targets of the WHO End-TB Strategy will not be achieved without addressing diagnosis and treatment of latent TB infection (LTBI). One forth to one third of the world’s population is infected with M. tuberculosis (MTB). While current diagnostic tests for infection show that an individual has been exposed to MTB, they poorly predict whether an individual will progress to active TB in the future.
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 clinical presentation as active disease).
Sample transport solution
Mycobacteria are slow-growing and therefore specimens require decontamination prior to inoculation into culture medium to avoid overgrowth due to other faster growing bacteria or fungi. Current standard methods for decontamination are suboptimal.
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.
Test of cure and treatment monitoring test
Currently recommended method for monitoring tuberculosis (TB) treatment have low sensitivity and specificity. As a result, treatment failure and relapse continue to be an important hurdle in TB control. Furthermore, no good marker is available to determine relapse-free cure.
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.
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