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WHO Releases First Essential List for IVD Tests

NEW YORK (360Dx) – The World Health Organization said today that it has published its previously announced Essential Diagnostics List, a first-of-a-kind report in which it identifies tests needed to diagnose the most common conditions, and diseases for which it has granted global priority status.

The list consists of 113 types of in vitro diagnostic tests. Of those, 58 are for detection and diagnosis of a wide range of common conditions, and provide "an essential package that can form the basis for screening and management of patients," the WHO said. The remaining 55 tests are designed for the detection, diagnosis, and monitoring of WHO priority diseases such as HIV, tuberculosis, malaria, hepatitis B and C, human papillomavirus, and syphilis. 

"An accurate diagnosis is the first step to getting effective treatment," Tedros Adhanom Ghebreyesus, WHO director-general, said in a statement. "No one should suffer or die because of a lack of diagnostic services, or because the right tests were not available."

Many people are unable to get tested for diseases because they cannot access diagnostic services, and many are incorrectly diagnosed, the WHO said, adding that as a result, patients do not receive the treatment they need and, in some cases, could receive the wrong treatment.

Some of the tests on the WHO list are particularly suitable for primary health care facilities, where laboratory services are often poorly resourced and sometimes non-existent, such as tests that can rapidly diagnose a child for acute malaria or glucometers to test diabetes. These tests do not require electricity or trained personnel, but other tests on its list are more sophisticated and, therefore, are intended for larger medical facilities, the WHO said.

Mariângela Simão, WHO assistant director-general for access to medicines, vaccines, and pharmaceuticals, said in a stattement, "Our other goal is to signal to countries and developers that the tests in the list must be of good quality, safe, and affordable."

For each category of test, the Essential Diagnostics List specifies the type of test and intended use, format, and whether it is 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.

Similar to the WHO Essential Medicines List, which has been in use for four decades, the Essential Diagnostics List is intended to serve as a reference for countries to update or develop their own list of essential diagnostics, the WHO said, adding that to benefit patients, national governments will need to ensure appropriate and quality-assured supplies, training of health care workers, and safe use. Further, the WHO noted that it will provide support to countries as they adapt the list to the local context.

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.

The WHO said it will update the Essential Diagnostics List on a regular basis. 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 non-communicable diseases, the WHO noted.