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  Table of Contents  
EDITORIAL
Year : 2018  |  Volume : 36  |  Issue : 2  |  Page : 153-154
 

WHO essential diagnostics list (2018): A revolutionary step in strengthening health laboratories at all levels of healthcare


Formerly Director Communicable Diseases, WHO Regional Office for South-East Asia, New Delhi, India

Date of Web Publication7-Aug-2018

Correspondence Address:
Rajesh Bhatia
Formerly Director Communicable Diseases, WHO Regional Office for South-East Asia, New Delhi
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijmm.IJMM_18_195

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How to cite this article:
Bhatia R. WHO essential diagnostics list (2018): A revolutionary step in strengthening health laboratories at all levels of healthcare. Indian J Med Microbiol 2018;36:153-4

How to cite this URL:
Bhatia R. WHO essential diagnostics list (2018): A revolutionary step in strengthening health laboratories at all levels of healthcare. Indian J Med Microbiol [serial online] 2018 [cited 2018 Dec 12];36:153-4. Available from: http://www.ijmm.org/text.asp?2018/36/2/153/238693


Recent past has witnessed rapid ascend of health in national and global development agendas. The United Nations Sustainable Development Goals (SDGs)[1] articulate a running thread of health across several SDGs. United Nations General Assembly (UNGA) has had a special session on antimicrobial resistance (AMR) in 2016.[2] UNGA is slated to have a similar high-level meeting on tuberculosis (TB) in 2018.[3] Universal Health Coverage (UHC) is recognised as the most ambitious of all public health programmes that aims to improve access to quality and affordable healthcare to all citizens,[4] especially those who have been resource deprived. A strong health system is a prerequisite for successful implementation of these global initiatives.

Quality health laboratories are an integral component of any efficient health system. The laboratories contribute significantly to the delivery of quality care at all levels of provision of health service. Some studies have shown that, though laboratory services may make up 5% of a hospital's budget but leverage 60%–70% of all critical decision-making such as admittance, discharge and medication.[5] These laboratory tests provide objective information so that patients can be diagnosed, treated or monitored precisely and rapidly. The laboratories also provide evidence and guidance for effective public health actions, especially disease surveillance, investigation of outbreaks and mounting an efficient response to health emergencies.

While importance of laboratory support is unambiguous, selection of appropriate tests at different levels of healthcare facilities has been difficult. One of the reasons has been availability of a plethora of diagnostic aides, especially in the developing countries – most of which may carry questionable evidence of efficacy and quality of performance, especially in the local settings. This usually baffles decision-makers and has potential of poor investment in unwanted or less desirable diagnostic tests.


 ~ Who's Essential Diagnostics List Top


Buoyed by the global success of Essential Medicines List and its widespread use during the past four decades, WHO has come out with a model list of essential diagnostics (EDL).[6] The WHO defines essential diagnostics as those that satisfy the priority healthcare needs of the population and are selected with due regard to disease prevalence and public health relevance, evidence of efficacy and accuracy and comparative cost-effectiveness.[6]

To begin with, the focus of WHO has been on in vitro diagnostics (IVD). IVD is a subset of medical devices and is defined as a device which, whether used alone or in combination, is intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes. It includes reagents, calibrators, control material and test kits.[6]

To provide a comprehensive list of diagnostics to the countries, the WHO has published the first edition of Essential Diagnostics List (EDL) in May 2018. It has been developed on the advice of the Global Strategic Advisory Group of Experts. Initially, it focusses selectively on HIV, TB, viral hepatitis and malaria that are disproportionate causes of both mortality and morbidity specially in the developing countries.


 ~ Categories of Tests Included In first Edition of Essential Diagnostics List Top


The first edition of the EDL consists of both specific diagnostic tests and general laboratory tests.

EDL describes 58 general laboratory tests that can be used for the routine patient care and for the detection and diagnosis of a wide array of diseases. The disciplines covered are clinical chemistry, blood transfusion, serology, microbiology, mycology, parasitology and haematology. These tests support routine diagnosis and monitoring of many conditions such as diabetes, cardiovascular, anaemia and liver function.[6]

For the specific diagnosis, the first edition of EDL includes 55 types of laboratory tests needed for the detection, diagnosis and monitoring of diseases, namely, HIV, TB, malaria, hepatitis B and C, syphilis and human papillomavirus.[6]

Future editions of EDL shall have the inclusion of IVDs for several other priority areas including AMR, non-communicable diseases and neglected tropical diseases, to name a few. An annual revision of EDL is aimed by the WHO and the process for amendments in EDL has been finalised.

Most of these diagnostics are supported by the WHO Pre-Qualification (PQ) programme, which plays a role in quality assurance of key tests for HIV, malaria and hepatitis B and C virus.[7] The availability of quality assured diagnostics shall be of immense use to the developing countries which do not have adequate infrastructure and expertise to ascertain the quality of these critical IVDs.

The EDL refers to tests according to their biological targets and does not use brand names. For each category of test, the EDL specifies following three features which will make this list very user-friendly:

  1. The scope, objective, rationale, instructions for use and target users
  2. For each IVD, assay format; specimen type, indications and the levels of healthcare at which these can be used
  3. The references, evidence, related policy documents and background information links to the WHO guidelines or publications and when available, to PQ or endorsed products.



 ~ Guiding Principles of Essential Diagnostics List Top


The guiding principles for EDL are the public health importance and potential to improve the health outcomes of communities, applicable to benefit patient and community, technical robustness, acceptable performance feasibility and availability of skills/competence at proposed health facility level, strong evidence on IVDs utility, possible availability of WHO PQ support, an optional advantage, existing policy guidelines to support IVD, ease of commercial availability within the country or through import, affordability for the country and strengthening health system for an efficient primary healthcare.

In addition, the types of testing that are appropriate at each tier will be country specific and will include, amongst others, factors such as access to electricity, reagent grade water, phlebotomy and specialised human resources.[8] Generically, four levels of healthcare facilities have been suggested under EDL. These are

  • Level I Peripheral health facilities (primary healthcare facilities
  • Level II District hospital and laboratory
  • Level III Regional, provincial and specialized hospitals and laboratories
  • Level IV National reference centres and laboratories.



 ~ Implementation of Essential Diagnostics List Top


To utilise EDL, national authorities may assess needs of IVDs at different levels of health facilities to address local diseases, support public health and national health initiatives including UHC and finalise their respective needs based on disease burden, infrastructure and skilled human resource available and network capabilities to provide comprehensive quality laboratory support to its citizens.

EDL has a clear objective of promoting greater access to quality and affordable IVDs at all levels of healthcare delivery system and their efficient applications contributing to a strong positive influence on all three WHO and global priorities, namely, (1) UHC, (2) emergencies and outbreaks and (3) improving health outcomes. Time is appropriate to support early and comprehensive implementation of EDL in all developing countries to improve clinical care and public health.

 
 ~ References Top

1.
Sustainable Development Goals; 2016. Available from: http://www.undp.org/content/undp/en/home/sustainable-development-goals/goal-3-good-health-and-well-being.html. [Last accessed on 2018 May 09].  Back to cited text no. 1
    
2.
United Nations General Assembly. Political Declaration of the High-Level Meeting of the General Assembly on Antimicrobial Resistance; 2016. Available from: http://www.digitallibrary.un.org/record/842813?ln=en. [Last accessed on 2018 May 16].  Back to cited text no. 2
    
3.
United Nations General Assembly. UN General Assembly High Level Meeting on Ending TB; 2018. Available from: http://www.who.int/tb/features_archive/UNGA_HLM_ending_TB/en/. [Last accessed on 2018 May 29].  Back to cited text no. 3
    
4.
Universal Health Coverage. Geneva: World Health Organization; 2018. Available from: http://www.who.int/universal_health_coverage/en/. [Last accessed on 2018 May 25].  Back to cited text no. 4
    
5.
Forsman RW. Why is the laboratory an afterthought for managed care organizations? Clin Chem 1996;42:813-6.  Back to cited text no. 5
[PUBMED]    
6.
WHO. World Health Organization Model List of Essentialin Vitro Diagnostics. Geneva: World Health Organization; 2018. Available from: http://www.who.int/medical_devices/diagnostics/WHO_EDL_2018.pdf. [Last accessed on 2018 May 23].  Back to cited text no. 6
    
7.
WHO. Prequalification of in vitro Diagnostics. Geneva: World Health Organization; 2018. Available from: http://www.who.int/diagnostics_laboratory/evaluations/en/. [Last accessed on 2018 May 21].  Back to cited text no. 7
    
8.
WHO. Guidance for Procurement of in vitro Diagnostics and Related Laboratory Items and Equipment. Geneva: World Health Organization; 2017. Available from: http://www.who.int/diagnostics_laboratory/publications/procurement/en/. [Last accessed on 2018 May 27].  Back to cited text no. 8
    




 

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