Forty years ago, 134 countries pledged to assure “Health For All” by the year 2000. They failed to deliver on that pledge. Today, at least 400 million people have no access to basic medical care, and 40% of the world’s population lacks social security protection.

Health is a human right. Humanity’s failure to provide universal health coverage (UHC) is a violation of this right and must be addressed as a top priority. But it won’t truly happen unless the ability to detect illnesses and outbreaks is made an integral part of it.

Thankfully, universal health coverage has re-emerged as a top priority for the World Health Organization, and is an essential element of the Sustainable Development Goals that were endorsed by all countries in 2015. Sustainable Development Goal 3.8 sets the following target for the year 2030: “Achieve universal health coverage, including financial risk protection, access to quality essential health care services and access to safe, effective, quality, and affordable medicines and vaccines for all.”

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As countries make progress toward universal health coverage and design and deliver their essential health benefits packages, diagnostics must be included as a key component of such packages. Why? Because most diseases or conditions cannot be correctly managed without a clear diagnosis. High-quality health care begins with seeking care, followed by a diagnosis that leads to appropriate therapy. Individual disease and outbreaks can’t be stopped if the cause is not identified early.

Yet hardly any universal health coverage report or statement explicitly acknowledges the need for including essential diagnostics within the framework of universal health coverage. That stands in sharp contrast to the explicit inclusion of access to essential medicines and vaccines in most universal health coverage statements and declarations.

Even the WHO did not emphasize the value of diagnostics until recently. While it released the first Essential Medicines List in 1977, it wasn’t until 2018 that it released its first Essential Diagnostics List. The first edition of the list included 113 tests, such as blood glucose and a rapid test for malaria. The second edition is expected to be released this month during the 72nd World Health Assembly. On the sidelines of the assembly, a special event will address the issue of diagnostics within the universal health coverage agenda.

When diagnostics are not acknowledged as an essential component of the health care system, they get little attention, budget, and support for implementation. If tests are not explicitly listed in national health plans or benefits packages, there is no mechanism for procurement, supply, and reimbursement.

The consequences of underinvestment in diagnostics and laboratories are clear. The laboratory infrastructure in most low- and middle-income countries is very weak. Even basic tests are missing in many health facilities. In a study of 10 countries, only 2% of health care facilities had the ability to perform eight basic tests — for blood glucose, hemoglobin, malaria, urine dipstick for protein and sugar, HIV, syphilis, and pregnancy. Despite the importance of pathology in cancer care, countries in sub-Saharan Africa have at best one-tenth the pathology coverage of high-income countries.

In the absence of laboratory support, health care providers have no choice but to resort to empirical and syndromic treatment. In several countries, “mystery patient” studies that used trained actors to simulate various diseases have shown that primary care providers make correct diagnoses in less than one-third of patients who present with typical symptoms of angina, tuberculosis, asthma, diarrhea, and pneumonia. Such studies have also shown high use of broad-spectrum antibiotics. It is no surprise that antimicrobial resistance has emerged as a huge global health problem.

Even when diagnostic tests are available, health systems are often unable to effectively leverage them. Studies on cascade of care models clearly demonstrate that diagnosis is the biggest gap in the continuum of care. Take tuberculosis, the most important infectious cause of death around the world. In 30 countries with high burdens of this communicable disease, on average only 65% of cases were properly diagnosed. Or take diabetes, a common non-communicable disease. In 28 low- and middle-income countries, only 63% of those with diabetes had ever been tested with a blood glucose measurement.

Similar cascade-of-care analyses for HIV, hepatitis C, hypertension, and prevention of mother-to-child HIV transmission have each shown big gaps at the diagnosis stage. The consistency of diagnosis as a key gap across disease areas and settings is quite remarkable and underscores the chronic neglect of diagnostics and laboratories in most low- and middle-income countries.

To address this massive gap, countries need to invest in tiered, connected, integrated laboratory networks, procure quality diagnostics, and train laboratory professionals to assess results. We must reject the mindset that simple, rapid tests and syndromic treatments are “enough for poor countries.” All patients, rich or poor, deserve to know their diagnosis.

The WHO Essential Diagnostics List is an important step in the right direction, as it sends a strong signal that diagnostic tests are as essential as medicines. It provides much-needed guidance to countries on what tests to prioritize and has already inspired some countries to develop their own national lists of essential tests. We hope more countries will do so and leverage the Essential Diagnostics List to plug the access gap in diagnosis.

We also need to work harder to develop novel diagnostics to address the biggest unmet needs. This includes tests for fever, antimicrobial resistance, so-called neglected tropical diseases, and others, as well as digital health solutions to address the massive epidemic of non-communicable diseases. Research and development investments are vital and need to be commensurate to the scale of need. Currently, R&D spending on diagnostics is a tiny fraction of the investments in drugs and vaccines.

Later this year, the United Nations General Assembly will host a high-level meeting on universal health coverage. It will bring together heads of state, political and health leaders, policymakers, and champions of universal health coverage to advocate for health for all. We call on these stakeholders to include diagnostic tests as a key component of the UHC agenda and prioritize diagnostics in the global response to antimicrobial resistance and pandemics.

It is time to acknowledge that diagnostics are as important as medicines and vaccines in delivering UHC. How can we cure illnesses we cannot detect?

Madhukar Pai is a Canada research chair in epidemiology and global health at McGill University in Montreal, the director of McGill’s Global Health Programs, and director of the McGill International TB Centre. Catharina Boehme is the chief executive officer of the Foundation for Innovative New Diagnostics (FIND), a global non-profit organization based in Geneva. Ilona Kickbusch is the director of the Global Health Centre at the Graduate Institute of International and Development Studies in Geneva, and co-chair of the UHC2030 Steering Committee.

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  • This is a very educative document. Self testing in HIV diagnosis is crucial and should be integrated in UHC.

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