By Diagnostics World Staff
May 24, 2018 | Last week the World Health Organization released its first list of essential diagnostic tests to improve diagnosis and treatment outcomes. The WHO’s Essential Diagnostics List is a catalogue of the tests needed to diagnose the world’s most common conditions as well as a number of global priority diseases.
Diagnostics continues to be a sticking point for healthcare worldwide. “How can we deliver quality primary health care, if we can’t even diagnose common and priority conditions? And how can we detect and control outbreaks, if we don’t know what we are dealing with?” Madhukar Pai, Director of Global Health & Professor at McGill University wrote in a blog post published when the list was announced.
Pai served on the WHO SAGE IVD Group that drafted the Essential Diagnostics List, and he argues that while the list is a bit late—40 years after WHO published an Essential Medicines List—it is still invaluable.
“With the emergence of AMR [antimicrobial resistance], pandemic threats, and non-communicable diseases, we simply cannot afford to only keep pushing medicines and vaccines as the panacea,” he said in an email to Diagnostics World. “As they say, without diagnosis, medicine is blind. Without diagnostics, we cannot contain outbreaks, nor care for people with NCDs.”
The list concentrates on in vitro tests - i.e. tests of human specimens like blood and urine. It contains 113 products: 58 tests are listed for detection and diagnosis of a wide range of common conditions, providing an essential package that can form the basis for screening and management of patients. The remaining 55 tests are designed for the detection, diagnosis and monitoring of “priority” diseases such as HIV, tuberculosis, malaria, hepatitis B and C, human papillomavirus and syphilis.
For each category of test, the Essential Diagnostics List specifies the type of test and intended use, format, and if appropriate for primary health care or for health facilities with laboratories. The list also provides links to WHO Guidelines or publications and, when available, to prequalified products.
The Essential Diagnostics List is intended to serve as a reference for countries to update or develop their own list of essential diagnostics. In order to truly benefit patients, national governments will need to ensure appropriate and quality-assured supplies, training of health care workers and safe use. Pai reports that countries including India, South Africa, and Ethiopia are already considering national EDLs.
Some of the tests are particularly suitable for primary health care facilities, where laboratory services are often poorly resourced and sometimes non-existent; for example, tests that can rapidly diagnose a child for acute malaria or glucometers to test diabetes. These tests do not require electricity or trained personnel. Other tests are more sophisticated and therefore intended for larger medical facilities.
The Essential Diagnostics List was developed following an extensive consultation within WHO and externally. The draft list was then considered for review by WHO’s Strategic Advisory Group of Experts on In-Vitro Diagnostics – a group of 19 experts with global representation.
Pai, who served among the advisors, says the list is a good first step.
“The WHO EDL is a good start, but will need to evolve and grow. It is currently neither perfect nor comprehensive, but I am confident future editions can be. In addition to WHO keeping the EDL updated on an annual basis, it is equally important that country governments adopt and adapt the EDL, to develop their own national EDLs. Most countries have their own national Essential Medicines List (EML). They would now need to create National EDLs, and make sure the EDL and EML are aligned, so that patients can access both tests as well as drugs.”
WHO will update the Essential Diagnostics List on a regular basis. In the coming months, WHO will issue a call for applications to add categories to the next edition. The list will expand significantly over the next few years, as it incorporates other important areas including antimicrobial resistance, emerging pathogens, neglected tropical diseases and additional noncommunicable diseases.
In the week since the list was published, Pai has noted positive reactions from the diagnostics industry, an opposite reaction from the Essential Medicines List reception four decades ago.
“I can see online that diagnostic companies have proudly announced that their products are included in the EDL, and I have seen no push back from the diagnostics industry on the EDL,” Pai wrote. “Hopefully, the industry can use the EDL to better understand what global health needs are, and invest in R&D to meet the needs. The EDL should also help ease problems with supply chain, lab capacity, import duties, procurement, etc.”