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3rd Essential Diagnostics’ List Launch

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When: Jan 29, 2021 02:30 PM Amsterdam, Berlin, Rome, Stockholm, Vienna

Topic: 3rd Essential Diagnostics’ List Launch

Webinar Link: (Please register in advance for this webinar) https://who.zoom.us/webinar/register/WN_WXNKujhjQKGqLbTqa8RxEA

WHO accepts rapid tests for life threatening fungal diseases aspergillosis and Pneumocystis pneumonia as ‘Essential Diagnostics’

The World Health Organisation, today issued its 2020 Essential Diagnostics list and included both rapid tests for invasive and chronic aspergillosis and Pneumocystis pneumonia.

The last few years have seen major steps forward in diagnostic accuracy and simplicity of tests for life-threatening fungal disease. Globally, aspergillosis affects over 10 million people while Pneumocystis affects approximately 500,000 people per year. Tests are mandatory for optimized clinical care – these infections are clinically subtle. Untreated most are fatal.

On behalf of millions of people affected each year, the Global Action Fund for Fungal Infections (GAFFI) applied for these tests to be included as Essential, using the 2-step procedure adopted by WHO. They were considered by the Strategic Advisory Group of Experts, this year using remote communications. The 3rd annual Model List of Essential in vitro Diagnostics was issued January[1]  29th 2021.

GAFFI had prepared the ground for these applications with an international consensus working meeting in Kampala, in April 2018, and subsequently published a paper summarizing the conclusions of the meeting [2] .

In addition to critically important fungal disease diagnostics, the WHO SAGE IVD group have evaluated PCR and other molecular tests for Covid-19. Several different assays are included in the 3rd Essential Diagnostics’ list, with commentary on their clinical and public health application.

The tests endorsed as essential were:

1. Aspergillus antigen – critical for the diagnosis of invasive aspergillosis which affects leukaemia, lung cancer, intensive care patients (including those with influenza and COVID-19), HIV and those admitted to hospital with COPD. The test is most sensitive in bronchoscopy fluids from all patients and blood from leukaemia patients. It is far superior to culture.

   Aspergillus antigen tests commercially available are listed here: http://www.life-worldwide.org/fungal-diseases/antigen-testing

2. Aspergillus antibody – critical for the diagnosis of chronic pulmonary aspergillosis which both mimics and complicates TB of the lungs. About 10% of TB patients have aspergillosis, not TB. Many patients with fungal asthma and Aspergillus sinusitis have positive Aspergillus antibodies too. Aspergillus antibody is 80-92% sensitive depending on the test used, again much more sensitive than culture.

   Antibody tests commercially available are listed here: http://www.life-worldwide.org/fungal-diseases/antibody-testing

3. Pneumocystis PCR – about 25% more sensitive than direct microscopy and 10% more sensitive than fluorescence microscopy, and the only test possible in young children with this infection. Pneumocystis jirovecii is a human only lung fungus that cannot be cultivated in the laboratory. PCR is a molecular test that has been sufficiently refined to be shipped to hot countries without dry ice, by some manufacturers. While doctors often suspect Pneumocystis pneumonia in AIDS, over-treatment leads to major drug side effects and no diagnosis and treatment is fatal.

   Pneumocystis PCR tests commercially available are listed here: http://www.life-worldwide.org/fungal-diseases/molecular-mycology


RESOURCES

3rd EDL describing the 175 test categories on the EDL

WHO Essential Diagnostics List

Bongomin Essential In Vitro Diagnostics EDL Eur J Clin Microbiol Infect Dis 2019