Essential Diagnostics List

A propos of Lab Week 2018, the WHO announced the development of an Essential Diagnostic List (EDL). The first Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) met in Geneva in April. The role of the SAGE-IVD is to act as an advisory body to matters of global policy and strategies related to in vitro diagnostics (IVDs) – to guide the development of the EDL.

The EDL is, as it sounds, a catalog of IVDs that are essential for diagnosis, treatment, and management of diseases. An EDL was called for in 2016 by Dr. Tim Amukele, a clinical pathologist at Johns Hopkins and President of the non-profit organization Pathologists Oveseas, and Dr. Lee Schroeder, a clinical pathologist at University of Michigan Ann Arbor (N Engl J Med 2016; 374:2511-4). Amukele and Schroeder suggested the EDL to complement the WHO’s Essential Medicines List (EML). They suggested 19 categories of IVDs that are essential for 10 of the medicines appearing on the EML. As it stands, the initial EDL focuses on 4 disease areas: HIV, TB, Malaria, and Hepatitis B & C. The following categories are provided for each disease area: analyte, intended use, level of facility that should have the IVD, assay format, specimen type, and links to WHO guidelines and any WHO prequalified or endorsed products.

For example, in the disease area “Malaria”, the analyte P. falciparum has the intended use of diagnosis of P. falciparum. The rapid diagnostic assay format is recommended for all level facilities. The specimen type is capillary whole blood, and the corresponding WHO guideline is “Good practices for selecting and procuring rapid diagnostic tests for malaria, 2011”.

The EDL will provide countries a way to focus attention on which tests are most appropriate, which can have a huge impact on the cost-effectiveness of the health care system, and also improve the quality of the laboratory results. Cost-effectiveness can be achieved by 1) focusing on evidence-based IVDs appropriate for a specific disease burden and 2) facilitating proper utilization of medicines and other clinical supplies necessary for treatment/management. In my experience, many laboratories in resource-limited areas are developed seemingly on a whim; testing might reflect a pet project of an absentee lab director, or donated equipment. Focusing on more appropriate testing, as Dr. Amukele told Clinical Laboratory News, give a lab more bang for their buck. Dr. Schroeder indicated that “lab testing develop ad hoc is more prone to quality issues”. The hope is that providing more direction for development of lab testing will encourage greater quality control programs. One way I can see that playing out is, if more labs in a specific area adopt the same testing, a shared sample program for cost-effective proficiency testing might be developed.

The WHO hopes that countries will use the EDL to develop country-specific EDLs, based on the disease burden specific to the country. National EMLs have been successful. Personally, I am very excited about the EDL! The WHO efforts to control HIV, Malaria, and TB have highlighted the need for laboratory diagnostics. I think it’s about time that labs got a chance to show their worth! The EDL is an important step in bringing the lab out of the basement and onto the global health stage.

 

Sarah Brown Headshot_small

Sarah Riley, PhD, DABCC, is an Assistant Professor of Pediatrics and Pathology and Immunology at Washington University in St. Louis School of Medicine. She is passionate about bringing the lab out of the basement and into the forefront of global health.  

One thought on “Essential Diagnostics List”

  1. Interesting comment, I assume that in the article they refer to nonfailed countries. I live in one failed country called Venezuela which is amid an outbreak of HIV, TB, Malaria, earlier in the year there were hepatitis. Insufficient diagnostics are accompanied by low to none treatment. I think that our neighbouring countries in south america will take the burden of those growing group of patients, we can’t and will not because it is a political decision of the regime. My point being, it is good to issue the Essential Diagnostic List , but it will remain nicely written,and put aside, while there is not political will to implement it ,so the spread of these diseases will continue unhindered.

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