FIND is gradually adding to its collection of diagnostics information and advocacy resources in the form of factsheets, FAQs, webinars and infographics. Some of the resources come from partners and some from FIND. If there are particular resources and topics that you would like to see included here, please let us know at firstname.lastname@example.org.
Why diagnostics R&D?
Diagnosis is the essential first step on the path to effective treatment.
- guide health care interventions, and measure treatment progress;
- increase the efficiency of health care spending by reducing misdiagnosis and inappropriate treatment;
- are the foundation of disease surveillance and elimination;
- aid in the fight against antimicrobial resistance by guiding the appropriate use of medicines, including antibiotics;
- help to control infectious diseases by ensuring that sick people are rapidly diagnosed and treated, thereby halting ongoing transmission.
Fever is one of the most common symptoms of illness around the world, whether from bacterial, viral or other causes.
Antibiotics may be effective for severe bacterial infections, but they do nothing for viral infections.
The inappropriate use of antibiotics is fuelling the rapid development of antimicrobial resistance globally, and it is reducing the effectiveness of the few treatment options we have for severe bacterial illness.
A simple, rapid point-of-care test to quickly distinguish between bacterial and non-bacterial or viral infections could greatly reduce the inappropriate use of antibiotics by guiding health workers towards appropriate treatment.
This would help to preserve the life-saving power of the world’s limited arsenal of these important drugs and help to ensure that people who are seriously ill get the treatment they need.
Hepatitis C virus (HCV) causes an estimated 350,000 deaths per year. Globally, from 130-150 million people are infected, with over 75% of infections and deaths occurring in low- and middle-income countries, where fewer than 1% of people living with HCV know they are infected.
Chronic hepatitis-related deaths have now surpassed HIV as the leading cause of death in many parts of the world. However, hepatitis C is now curable thanks to recently developed, highly effective drugs.
Now the major barriers to providing life-saving care and treatment for hepatitis C are:
- A lack of effective diagnostic tests, and
- The high cost of the newly available, highly effective drugs to treat the disease.
Existing diagnostic tests for HCV are complex, costly and require sophisticated infrastructure. In addition, current tests for HCV, such as serology, have limited accuracy in people living with HIV who are co-infected with HCV. Molecular tests are costly and, if available at all, are only found in highly centralized settings with experienced clinicians.
The treatment landscape for hepatitis C is currently undergoing a dramatic transformation. The development of potent, well-tolerated, all-oral treatments means that patients are cured more quickly, with cure rates of more than 90% after just 12 weeks of treatment compared to 48 weeks with previous treatments for all stages of hepatitis C.
The availability of new treatments presents a unique opportunity for the international health community to eliminate the hepatitis C epidemic in developing countries, which have thus far not had the resources to effectively fight this disease. Before that can happen, however, we urgently need new diagnostic tests that can be widely used to diagnose hepatitis C.
It is estimated that globally, about half of all people living with HIV do not know their HIV status. There is an urgent need to simplify HIV/AIDS diagnostics and to greatly increase access to affordable, high-quality diagnostic tools in resource-limited settings to enable earlier detection and treatment.
Diagnostic tools play an important role in diagnosing and monitoring the progression of HIV. HIV diagnostic tests are used to screen for and confirm HIV infection. CD4 tests are used to monitor the immune response of people living with HIV by measuring the quantity of CD4 T-cells in the blood. Viral load tests monitor the effectiveness of treatment by measuring the amount of HIV in the bloodstream.
While diagnostic tools exist for all of these purposes, some are too expensive or too complex for wide use in resource-poor areas that do not have fully equipped laboratories or trained staff. Rapid diagnostic tests for HIV are now much more widely available globally and only require a saliva swab or blood from a finger stick. However, early infant diagnosis remains a challenge, and many CD4 and viral load tests are expensive and not widely enough available outside larger population centres or in resource-limited settings.
There are also HIV tests that are used for epidemiological surveillance purposes. An example is a test that can help determine whether an infection is recent (i.e. within the past year), in order to support estimates of HIV incidence – in other words, to estimate the number of new infections in a population.
Why measure HIV incidence?
HIV incidence is the number of new HIV infections in a population in a defined time period.
HIV epidemics are often described in terms of the combination of incidence and prevalence, which measures the total number of people living with HIV, whether they were infected this year, last year or 20 years ago.
It is important to measure HIV incidence in order to know whether the number of new infections is going up or down. Measuring HIV incidence in a population allows us to:
- Accurately monitor the trajectory of national HIV epidemics and the global HIV pandemic,
- Ensure that the billions invested in HIV prevention efforts are targeting the right populations with the right interventions,
- Evaluate the effectiveness of HIV prevention and treatment programs by more accurately measuring reductions in new HIV infections,
- Plan and budget for future health care needs, including the costs of lifetime antiretroviral therapy for the millions of people living with HIV, and
- Help design clinical trials for emerging drugs, treatment regimens, and prevention interventions.
This is especially important in low- and middle-income countries, which carry a disproportionate share of the global HIV and AIDS burden.
- Why measure HIV incidence?
A diagnostic breakthrough that has revolutionized the fight against malaria is the use of rapid diagnostic tests (RDTs).
RDTs can provide a rapid, reliable and inexpensive malaria diagnosis at the community level where microscopy is often impractical or unavailable.
However, not all tests are of equal quality and they can provide variable results for a variety of reasons, including poor manufacture or exposure to high temperatures during transport and storage.
Advocating for quality assurance at all levels ensures that the RDTs being used provide reliable and accurate results and also that health-care providers and patients have confidence in test results. A lack of trust in results can lead to inappropriate treatment.
We have the tools to test RDT quality at three levels:
- the quality of the product itself,
- the quality of ongoing manufacturing (i.e. lot quality) and,
- the quality of RDTs following their transport and storage to health facilities and community health workers.
It is also important to advocate for the availability of high-quality RDTs not only in public sector health facilities but also with private sector health providers and pharmacies.
Pharmacies and small drug shops often serve as people’s first stop for health advice, especially where health care is expensive or too far away. Providers in these outlets can