The AEIOU of essential diagnostics: align, expand, implement, oversee, and update
Authors: Julia E von Oettingen, Ophira Ginsburg, Sandeep P Kishore, Sonak D Pastakia, Lee F Schroeder, Dan A Milner, Rajesh Vedanthan
Journal: The Lancet Global Health (2019)

Heart attack, diabetes, cancer: these common clinical diagnoses can (and should) be confirmed with a diagnostic test. However, in large parts of the world, up-to-date, cost-effective, and simple diagnostic tools remain unavailable.1Wilson ML Fleming KA Kuti MA Looi LM Lago N Ru K Access to pathology and laboratory medicine services: a crucial gap.Lancet. 2018; 391: 1927-1938Summary Full Text Full Text PDF PubMed Scopus (155) Google Scholar Patients and health-care providers in such settings are often reliant on so-called syndromic medicine, whereby diagnoses are made on the basis of clinical judgment and treatment is administered empirically. This approach is less than ideal, because it carries the risk of misdiagnosis, unnecessary or harmful treatments, adverse sequelae, and even death. In May, 2018, WHO took an important step towards improving access to diagnostic testing by publishing the first edition of the Model List of Essential In Vitro Diagnostics (referred to throughout as the Essential Diagnostics List, EDL).2WHOWorld Health Organization model list of essential in vitro diagnostics.https://www.who.int/medical_devices/diagnostics/WHO_EDL_2018.pdfDate: 2018Date accessed: November 1, 2018Google Scholar The assembled priority list, which acts as a guide for governments and health-care stakeholders,3Schroeder LF Guarner J Amukele TK Essential diagnostics for the use of World Health Organization essential medicines.Clin Chem. 2018; 64: 1148-1157Crossref PubMed Scopus (16) Google Scholar is an attempt at tackling the so-called diagnostics desert that prevails in many resource-limited settings. However, although efforts were made to widen the focus from infectious diseases to a broader spectrum of conditions, the EDL still insufficiently reflects the global epidemiological transition from infectious to non-communicable diseases. Nevertheless, the EDL sets an important starting point for the future. Recommending point-of-care blood glucose measurements and haemoglobin A1c testing could improve the detection rate of diabetes among people in low-income and middle-income countries who are not aware of their diagnosis, which can be as high as 50% of those with the condition. For patients who are having a heart attack, the availability of a troponin blood test could be life-saving. Basic and comprehensive metabolic panels, blood gas tests, and kidney function tests cover a wide range of evaluations required to diagnose various non-communicable diseases. Continued alignment of the EDL with the Essential Medicines List (EML), in terms of both content and process, will be important going forward. Although this first edition of the EDL targets high-burden diseases and diseases of public health importance, the next iteration will need to be expanded to include essential diagnostics for a wider range of non-communicable diseases. In addition, important tools and devices, such as growth charts and blood-pressure cuffs at the primary care level, electrocardiograms, X-rays, and ultrasound scans at the secondary care level, and CT and MRI scanners, pulmonary function tests, advanced surgical devices, and fibre-optic scopes at the tertiary care level, will be vital for a shift from syndromic diagnosis and management to health-care delivery that uses diagnostic technology to its full advantage. The term essential must be defined on the basis of effects on morbidity and mortality, regardless of implementation challenges. The needs of children should be considered, including specific testing (eg, neonatal screening), specialised phlebotomy, testing of small-volume samples, and size-adjusted equipment. The EDL could have a substantial effect on the global availability of diagnostics, similar to the downstream effects of the EML.4Bazargani YT Ewen M de Boer A Leufkens HG Mantel-Teeuwisse AK Essential medicines are more available than other medicines around the globe.PLoS One. 2014; 9: e87576Crossref PubMed Scopus (75) Google Scholar However, its impact on the actual availability of essential diagnostics will depend on successful implementation, including translation of EDL guidelines into national lists, combined with strengthening of national laboratory systems. Putting EDL recommendations into effect will require adequate resourcing by funders, priority setting by national governments, and reductions in prices of diagnostic tools and devices by manufacturers and suppliers. Engagement from global pathology and laboratory medicine organisations will be needed to support implementation. Furthermore, national and international stakeholders, including governments, international organisations, and donors, will need to commit to appropriate oversight of laboratory accreditation and personnel certification to ensure compliance with standards. High-quality services, including sustainable supply chains, appropriate calibration and validation of results, reliable specimen transport between tiers, and reduction of unnecessary testing will also be required.5Wirtz VJ Hogerzeil HV Gray AL et al.Essential medicines for universal health coverage.Lancet. 2017; 389: 403-476Summary Full Text Full Text PDF PubMed Scopus (302) Google Scholar Finally, the EDL needs to be regularly updated. Fortunately, modern communication technology allows for a timely updating process. Successful efforts have been made to modernise the EML for cardiovascular disease,6Kishore SP Blank E Heller DJ et al.Modernizing the World Health Organization list of essential medicines for preventing and controlling cardiovascular diseases.J Am Coll Cardiol. 2018; 71: 564-574Crossref PubMed Scopus (27) Google Scholar and a similar strategy could be implemented to update the EDL. The creation and subsequent monitoring of national and local EDL by a designated WHO committee or dedicated regulations will be crucial to ensure the adoption of core diagnostics on a large scale. This is a call to action to ensure that the EDL does not remain only a document, but instead becomes an active tool that addresses an ever-broadening spectrum of diseases, allowing patients globally to have access to proper diagnosis and treatment, and a better chance of survival. The five As of access will need to be a focus of advocacy efforts: affordability, availability, accessibility, accommodation, and acceptability (figure). With political guidance, willpower, and necessary pressure, public and private entities will need to work towards affordability of essential diagnostics. Strengthened national, regional, and local health systems will need to sustain supply chains and specimen transport systems to ensure availability and accessibility to patients in all settings. Innovative testing strategies that accommodate the needs of remote and susceptible populations will need to be developed so that test approaches are acceptable and reach patients wherever they live. SDP reports personal fees from Abbott outside the submitted work. All other authors have no competing interests.