Executive summary

World Health Organization Model List of

Essential In Vitro Diagnostics
First edition (2018)

Report of the first Strategic Advisory Group on In Vitro

Diagnostics (SAGE-IVD)
WHO headquarters, Geneva, 16–20 April 2018
Contents

Executive summary ................................................................................................................................ 2

Recommendations of the Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE-IVD).. 4
List of participants .................................................................................................................................. 5
Declaration of interests.......................................................................................................................... 7
Annex 1: WHO Model List of Essential In Vitro Diagnostics, first edition ............................................ 8
Preface ................................................................................................................................................ 8
List of Essential In Vitro Diagnostics (EDL) ...................................................................................... 15
I List of Essential In Vitro Diagnostics (EDL): For primary health care .......................................... 15
I.2 List of Essential In Vitro Diagnostics (EDL): For health care facilities with clinical laboratories
...................................................................................................................................................... 21

1
Executive summary

Access to good quality, affordable, and appropriate health products is indispensable to advance
universal health coverage, address health emergencies, and promote healthier populations – the
three strategic priorities of the World Health Organization (WHO) Thirteenth General Programme of
Work 2019–2023.1Without access to In vitro diagnostics (IVDs), health providers cannot diagnose
patients effectively and promptly or provide appropriate treatments.

In March 2017, the WHO Expert Committee on Selection and Use of Essential Medicines
recommended the development of a Model List of Essential In Vitro Diagnostics (EDL), to
complement the WHO Model List of Essential Medicines (EML). To support the EDL and to advise on
other in vitro diagnostic initiatives, WHO created a Strategic Advisory Group of Experts on In Vitro
Diagnostics (SAGE-IVD). The SAGE-IVD, which includes 19 multidisciplinary members with global
representation, held its first meeting from 16–20 April 2018 at WHO headquarters, Geneva. The
SAGE IVD made recommendations for the content, format and implementation of the first edition of
the EDL.

It is foreseen that EDL will be an important tool in increasing access to appropriate, affordable and
quality-assured IVDs, particularly where they are most needed to address health priorities.

Scope and selection of IVDs for inclusion in the first edition of the EDL
The EDL focusses on IVDs, a subset of medical devices intended for the in vitro examination of
specimens derived from the human body, solely or principally to provide information for diagnostic,
monitoring or compatibility purposes.

The WHO developed a draft EDL, which was posted on the WHO website and sent to relevant
external stakeholders for comment. The draft list, with the comments received, was provided to the
SAGE-IVD members at their meeting for their review and recommendations.

The SAGE IVD confirmed a list of general IVD tests that should be available in primary health care
settings, and in hospitals and reference laboratories, for routine patient care. The information to
select the general diagnostic tests was compiled from existing WHO guidance, guidelines, technical
manuals and the priority medical devices lists.

The disease-specific IVDs were selected from WHO evidence-based guidelines, information from the
WHO Prequalification of In Vitro Diagnostics Programme (PQ), or from other WHO IVD assessment
processes.

EDL content and format

The first edition of the EDL consists of:

 58 general laboratory tests that can be used for routine patient care and for the detection
and diagnosis of a wide array of diseases communicable and noncommunicable, in the
disciplines of clinical chemistry, blood transfusion, serology, microbiology, mycology,

1
WHO (2018). Thirteenth General Programme of Work 2019–2023 (http://www.who.int/about/what-we-
do/gpw-thirteen-consultation/en/).

2
 parasitology and haematology. These tests support routine diagnosis and monitoring of
many conditions such as diabetes, cardiovascular, anaemia, liver function.
 55 types of laboratory tests needed for the detection, diagnosis and monitoring of HIV,
tuberculosis, malaria, hepatitis B and C, syphilis and human papilloma virus. For each
category of test, the EDL specifies: test category and purpose; assay format; specimen type;
and, health care facility level for most appropriate use (e.g. primary care with no or minimal
laboratories versus facilities with laboratories). Links to WHO guidelines or publications and,
when available, to prequalification or endorsed products. The EDL refers to tests according
to their biological targets and does not use brand names.

EDL intended audience and use

The EDL is not prescriptive; rather it is expected that the EDL will provide guidance and serve as a
reference to Member States and other parties involved in developing and/or updating lists of
national essential IVDs and/or medical devices, and selecting and implementing such IVDs.

While the EDL provides a list of important tests required at various levels of the health system,
ranging from primary health care to reference hospital and laboratories, it is important to note that
the EDL alone cannot have an impact. It requires an integrated, connected, tiered laboratory system,
with adequate human resources, training, laboratory infrastructure, and regulatory and quality
assurance systems. Impact also requires Member States to adopt and adapt the EDL, to develop
national or regional EDLs, and to implement the supply mechanisms necessary to ensure access to
the required IVDs.

In order to effectively use the EDL and adapt it to national needs, Member States will need to
consider a variety of factors, including local demographics and burden of disease; treatment
facilities; access to reagents and basic infrastructure; training and experience of available personnel;
local and unmet testing gaps; supply chain and transport links; facility quality assurance coverage
and capacity; local availability of treatments; financial resources; information technology
capabilities; local disease elimination priorities; and environmental factors. To that end, information
that supports the selection and use of the IVDs on the EDL, and links to relevant WHO clinical
guidelines, lists of prequalified IVDs and IVDs recommended by WHO disease control departments,
and other relevant resources, will be consolidated on the WHO website together with the EDL. This
compendium of materials is intended to support country uptake and facilitate implementation.

Next steps
The EDL will be updated annually. WHO will issue a call for applications to add IVD test categories to
the next edition of the EDL in mid-2018. The first EDL will be expanded significantly over the next
few years, incorporating other important areas such as antimicrobial resistance, additional
noncommunicable diseases (NCDs), emerging pathogens, emergencies and outbreaks, and neglected
tropical diseases.

WHO acknowledges the technical input from all SAGE-IVD members, and the comments from
stakeholders, and thanks the Department for International Development, United Kingdom, for
providing a grant to support this process.

3
Recommendations of the Strategic Advisory Group of
Experts on In Vitro Diagnostics (SAGE-IVD)

Background
The Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE-IVD):
 Welcomed the creation of SAGE-IVD by WHO to act as an advisory body with respect to
matters of global policies and strategies related to IVDs.

 Supports WHO’s focus on universal health coverage, to ensure that all people have access to
a full spectrum of essential, quality health services, including diagnostics. Essential medicines
require essential diagnostics, and SAGE-IVD applauds WHO for the decision to create a WHO
Model List of Essential In Vitro Diagnostics (EDL), to complement the EML, which has been a
very successful public health strategy in enhancing access to medicines.

Recommendations

 Recognizing the importance of tests for a wide variety of diseases, SAGE-IVD reviewed and
agreed on a proposal for the first EDL, which should include a broad list of basic laboratory
tests, as well as tests for the following initial set of diseases pursuant to WHO policy and for
which there is high quality guidance: HIV, TB, malaria, HBV/HCV, and HPV and syphilis
infections.

 Consider the following tests be included in future editions of the EDL: antimicrobial resistance,
neglected tropical diseases, NCDs, outbreaks/emergencies and sepsis.

 Include a detailed preface to the EDL to explain the objectives, limitations and guidance for its
use. The preface should include: the scope of the EDL; a definition of the health service levels
referred to; the rationale for the contents; and stress the need to adapt the list to local or
regional settings and conditions (one size does not fit all).

 Emphasize that while the EDL provides a list of important tests required at various levels of the
health system, the list itself cannot have an impact without an integrated, connected, tiered
laboratory system, with adequate human resources, training, laboratory infrastructure,
regulatory and quality assurance systems.

 Member States can adapt the EDL and develop national or regional EDLs, as well as implement
the mechanisms necessary to ensure impact.

 Revise and update various WHO technical documents that constitute a resource for EDL to
make them relevant and current. This task should be prioritized, and if need be, supported by
WHO collaborating centres, other institutions and SAGE-IVD.

 Support EDL via a dedicated web page that harmonizes all IVDs information available on the
WHO website.

 Review and acknowledge that the WHO prequalification process plays an important role in
increasing access to IVDs of assured quality, safety and performance. SAGE-IVD appreciates that

4
 EDL and the WHO Prequalification of In Vitro Diagnostics Programme (PQ) are
complementary processes in improving access to IVDs for Member States.

List of participants
SAGE-IVD members
George Araj, Professor and Director of Clinical Microbiology, Department of Pathology and
Laboratory Medicine, American University of Beirut Medical Center, Lebanon.

Susan Best, Former Director, National Serology Reference Laboratory, Australia.

Rajesh Bhatia, Former Director, Communicable Diseases, WHO Regional Office for South-East Asia,
India.

Jane Carter, Technical Director, Clinical and Diagnostics, Amref Health Africa, Kenya.

Francois Chappuis, Head of Division of Tropical and Humanitarian Medicine, HUG; Associate
Professor, UNIGE; Medical Advisor (human African Trypanosomiasis), MSF, Switzerland.

Jonathan Deeks, Professor of Biostatistics, Associate Director of the Birmingham Clinical Trials Unit,
Deputy Director of the Institute of Applied Health Research, United Kingdom.

Anthony Emeribe, Professor of Haematology, University of Calabar and Registrar/CEO, Medical

Laboratory Science Council of Nigeria, Nigeria.

Hortense Yaobla Faye-Kette, Professor of Microbiology, Bacteriology and Virology at Medical

Sciences School, University Felix Houphouet-Boigny, Abidjan, Côte d’Ivoire.

Sally Hojvat, Independent Consultant on diagnostics, United States of America.

Hairong Huang, Director of National Tuberculosis Clinical Laboratory of China, CDC, China.

Jan Jacobs, Professor in Tropical Laboratory Medicine, Institute of Tropical Medicine, Belgium.

Noppavan Janejai, Deputy Director, National Institute of Health, Department of Medical Sciences,
Thailand.

Adrian Newland, Professor of Haematology, The Royal London Hospital, Barts Health NHS Trust,
United Kingdom.

Madhukar Pai, Canada Research Chair in Epidemiology and Global Health; Director, McGill Global
Health Programs; Associate Director, McGill International TB Centre; McGill University, Department
of Epidemiology and Biostatistics, Canada.

Rosanna Peeling, Director, International Diagnostics Centre; Professor and Chair of Diagnostics
Research, London School of Hygiene and Tropical Medicine, United Kingdom.

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Olga Perovic, Principal Pathologist, Antimicrobial Resistance Laboratory and Culture Collection
Centre for Healthcare-Associated Infections, Antimicrobial Resistance and Mycoses (CHARM),
Associate Professor, University of Witwatersrand, South Africa.
Kamini Walia, Lead, Antimicrobial Surveillance Network, Senior Scientist, Division of Epidemiology
and Communicable Diseases, Indian Council of Medical Research, India.

Apologies received from: Philip Edward Castle, Professor, Department of Epidemiology and
Population Health, Albert Einstein College of Medicine, United States of America; and Welile
Sikhondze, Technical Advisor and Research Coordinator, Swaziland National TB Control Program,
Swaziland.

Observers
Klaus Cichutek and Clare Morris, Expert Committee on Biological Standardization (ECBS)

WHO Secretariat
Soumya Swaminathan, Deputy Director-General
Mariângela Simão, Assistant Director-General, Access to Medicines, Vaccines and Pharmaceuticals
Cluster

Disease areas technical officers

Carmen Pessoa da Silva, antimicrobial resistance
William Perea, emergencies and outbreaks
Jane Cunningham Global Malaria Programme
Christopher Gilpin, Global TB Programme
Terry Besselaar, high threat pathogens
Lara Vojnov, HIV/AIDS and hepatitis
Annette Kuesel, neglected tropical diseases
Andre Ilbawi, cancer diseases
Melanie Taylor, human reproduction
Alma Alic, compliance and risk management and ethics
Jacob Quirin, governing bodies and public international law

Department of Essential Medicines and Health Products

Suzanne Hill, Director
Emer Cooke, Coordinator, regulation of medicines and other health technologies
Deus Mubangizi, Irena Prat, Willy Urassa, prequalification
Anita Sands, safety and vigilance
Bernadette Cappello, Lorenzo Moja, Secretariat of the Expert Committee on Drug Selection and Use
of Essential Medicines
Ivana Knezevic, François-Xavier Lery, technical standards and norms

Sarah Garner, Francis Moussy, Magdalena Rabini, Adriana Velazquez, EDL Secretariat, Innovation
Access and Use, Department of Essential Medicines and Health Products

Lucy Hattingh, Maurine Murtagh, Lee Schroeder, external consultants

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Declaration of interests
Declaration of interests of SAGE-IVD members
Professor Madhukar Pai advised that he consulted with the Bill & Melinda Gates Foundation and
provided technical assistance to their TB India Program. The consultancy ended on 31 March 2018.
He is a member of the Scientific Advisory Committee of Foundation for Innovative New Diagnostics
(FIND) and serves on the Access Advisory Committee of the Global Alliance for TB Drug
Development. Since 2015, he has also been part of WHO’s STAG TB Advisory Committee.

Dr Susan Best advised she was provided support by DiaSorin to attend a European Society of Clinical
Virology conference in Italy in September 2017, where she presented a poster that reported on the
performance of the DiaSorin Liaison hepatitis B immunoassay when used with blood specimens
collected from cadavers. DiaSorin did not financially support the work that led to the presentation.

Dr Jonathan Deeks advised that he completed a review of WHO guidelines related to diagnostics for
TB, malaria, HIV and hepatitis with a view to harmonizing processes. Dr Deeks also developed
background materials for the HIV Department to support their guideline development.

Dr Sally Hojvat advised that in 2016–2017 she received two HPV diagnostic device dossiers and
subsequent deficiency responses from diagnostics companies for the WHO PQ team. She also looked
at several product technical specification documents for the WHO PQ team in 2016–2017.
Additionally, Dr Hojvat provides advice to a regulatory contractor (Dr Elliot) for non-profit
institutions and commercial diagnostic companies on matters related to the US Food and Drug
Administration (FDA) pre- and post-commercialization regulatory policy, which involves infectious
disease diagnostics (except for HIV moderate complexity laboratory tests). She provides advice to
the same contractor on matters related to human subject protection as they relate to clinical trials
for diagnostic devices. Further, Dr Hojvat worked as the Director of the Division of Microbiology at
the FDA and her division was responsible for the review and evaluation of safety and effectiveness of
all IVD microbiology devices (reagents, software and instruments) submitted to the FDA for pre-
market device clearance/approval/CLIA waiver and emergency use authorization and responsible for
pre-market and post-market compliance actions associated with IVD microbiology devices. She also
represented FDA on human subject protection issues and was responsible for outreach activities
concerning infectious disease IVD issues, including response to emerging pathogens, e.g. influenza
H1N1, MERS, Ebola etc. and potential bio-threats such as anthrax, plague etc., working with USA
health and human services agencies (NIH, CDC, BARDA, PHEMCE), the Department of Defense
research laboratories and WHO PQ regulatory teams

The EDL Secretariat reviewed the above noted disclosures and determined that there was no conflict
of interest in respect of the meeting and the full participation of these experts.

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Annex 1: WHO Model List of Essential In Vitro Diagnostics,
first edition
Preface
Introduction
The World Health Organization (WHO) published the first edition of the Model List of Essential In
Vitro Diagnostics (EDL) in May 2018, in recognition that IVDs are an essential component to advance
universal health coverage, address health emergencies, and promote healthier populations, which
are the three strategic priorities of the WHO Thirteenth General Programme of Work (2019–2023)
(GPW). The EDL is also intended to complement the WHO Model List of Essential Medicines (EML)
and enhance its impact.

Objectives of the Model List of Essential In Vitro Diagnostics (EDL)

The EDL outlines a group of IVDs that are recommended by WHO for use at various levels of a tiered
national health care system. The EDL is not intended to be prescriptive with respect to the IVDs
listed or the levels at which such IVDs can/should be used; rather country programmes should make
the ultimate decisions about which IVDs are selected and where they are implemented, based on
national or regional burden of disease, unmet needs and priorities.

It is expected that the EDL will provide guidance and serve as a reference to Member States
(including ministries of health, programme managers, end users such as laboratory managers,
procurement officers and reimbursement systems), who are developing and/or updating lists of
national essential IVDs for defining universal health coverage interventions, as well as selecting and
implementing such IVDs. It will also inform United Nations agencies and nongovernmental
organizations that support selection, procurement, supply, donations or provision of IVDs. Finally, it
will inform and guide the medical technology private sector on IVD priorities and the IVDs needed to
address global health issues.

While the EDL provides a list of important tests required at various levels of the health care system,
it is important to note that the EDL itself cannot have an impact without an integrated, connected,
tiered laboratory system, with adequate human resources, training, laboratory infrastructure, and
regulatory/quality assurance systems. Impact also requires Member States to adopt and adapt the
EDL and develop national and regional EDLs, as well as to implement the selection and supply
mechanisms necessary to ensure access to the IVDs.

Scope of the first edition of the EDL

Based on the EDL selection criteria described below, the EDL consists:

 A group of general laboratory tests that can be used for routine patient care as well as for
the detection and diagnosis of a wide array of disease conditions – communicable and NCDs.
These IVDs are grouped by test discipline (e.g. clinical chemistry, serology, haematology,
microbiology and mycology) and specific test type (e.g. bilirubin, complete blood count,
etc.).

8
  IVDs designed for the detection, diagnosis and monitoring of each of the following WHO key
disease areas: HIV, TB, malaria, HBV/HCV, and HPV and syphilis. These IVDs are grouped by
disease area and analyte tested.

The EDL does not list specific test brands, but rather consists of IVDs described according to their
biological targets. Where specific products in categories of tests contained in the EDL have been
prequalified by WHO or are recommended by a WHO disease programme, a link is provided to that
information, which is updated regularly.

EDL content and format

For each specific test listed in the first edition of the EDL, the following are described:

 Test purpose: Purpose for which the test can be utilized.

 Assay format: The assay format or formats in which the test is generally
available, e.g. enzyme immunoassay, nucleic acid testing.
 Specimen type: The types of specimens that can be used for the test.
 Facility level: The level of the tiered health care delivery system for which
the test is suggested, as described below.
 Link to WHO guidance: If there is existing WHO guidance available on the test or
category of testing, a link is provided to the appropriate
location on the WHO website.
 WHO PQ or endorsed products: For each specific test for which there are brands of products
either prequalified by WHO or otherwise endorsed by WHO,
a link is provided.

The EDL is presented by health care facility level in two tiers:

I IVDs for Primary health care;

II IVDs for Health care facilities with clinical laboratories.

Recommended use of the EDL

In order to effectively use the EDL and adapt it to national needs, WHO recognizes that Member
States will need to consider a variety of factors. These include, among others: local demographics
and burden of disease; local disease elimination priorities; local availability of treatments; training
and experience of available personnel; local unmet needs and testing gaps; supply chain and
transport links; quality assurance capacity; financial resources; information technology capabilities;
and environmental factors.

To that end, information that supports the selection and use of IVDs on the EDL, such as relevant
WHO clinical guidelines, selected systematic reviews, key references, lists of prequalified IVDs and
IVDs recommended by WHO disease control departments, as well as other relevant resources on
quality assurance, basic techniques, procurement and maintenance guidance, will be collated and
maintained on the WHO website on an IVD-specific webpage linked to the EDL.

The EDL should not be used in isolation, but in the context of the scope of testing services that meet
the clinical needs and expectations in each country through their own particular laboratory
networks. An illustrative example of a tiered health care delivery and laboratory network in

9
resource-limited countries is set out in Figure 1. The pyramid of testing reflects that there are
generally a large number of primary care facilities and that they serve most patients directly for
primary care needs. As one goes up the levels of the system, there are a smaller number of
centralized facilities serving fewer patients directly. In the case of national reference laboratories
and some provincial laboratories, they may not serve patients directly or they may offer a broad set
of specialist consultative services, and act more as referral centres for quality assurance and training
or for conducting complex tests (either using samples drawn at facilities lower in the system and
transported or by receiving patients referred directly from other facilities).

Figure 1. The types of testing that are appropriate at each tier will be country-specific and will
include, among others, factors such as access to electricity, reagent grade water, phlebotomy and
specialized human resources.2

For purposes of the first edition of the EDL and to simplify its presentation and use, IVDs are listed
for two tiers: primary care settings where no or minimal laboratories are available (Level I in Figure
1) or for laboratory-based facilities (Levels II, III, and IV in Figure 1).

Process of development of the first edition of the EDL

In March 2017, the WHO Expert Committee on Selection and Use of Essential Medicines
recommended that an EDL be developed. In support of that recommendation, WHO created an EDL
Secretariat, which drafted the first edition of the EDL in consultation with colleagues in the various
WHO disease programmes. It was then posted online for open consultation. WHO also created a
Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE-IVD) to support the development
of the EDL and to advise on other IVD policies and initiatives. SAGE-IVD held its first meeting from
16–20 April 2018 at WHO headquarters, Geneva, where it made recommendations for the content,
format and implementation of the first edition of the EDL, as well as its processes moving forward.

2
Adapted from: WHO (2017). Guidance for procurement of in vitro diagnostics and related laboratory items
and equipment (http://www.who.int/diagnostics_laboratory/publications/procurement/en/).

10
Selection of IVDs for inclusion in the first edition of the EDL
The selection of the diagnostics tests for the EDL took into account the following priorities:

 IVDs for primary care settings, providing an essential diagnostics package that can form the
basis for screening and case management of patients at entry-level health care facilities.
 Public health approach, providing information on access to affordable, quality-assured IVDs,
targeting high burden diseases, both communicable diseases and NCDs, and diseases of
public health importance.
 IVDs for priority diseases such as HIV, TB, malaria, hepatitis HBV/HCV, and HPV and syphilis
infections.

Specifically, the general laboratory diagnostics in the first edition of the EDL were compiled based on
existing WHO guidance, guidelines and technical manuals and priority medical devices lists, which
are referenced at the end of the list.

The disease-specific IVDs were selected from WHO evidence-based guidelines, which are referred to
in the EDL with links to the respective documents. An additional factor considered by WHO was the
availability of evidence from the WHO Prequalification of In Vitro Diagnostics Programme (PQ), or
from other WHO IVD assessment processes, as applicable, which further support the choice of
certain diagnostic test categories. Links to relevant documents are provided in the EDL by type of
test.

Process for updating the EDL going forward

The EDL will be expanded and updated annually with the intention to ultimately cover a broad,
comprehensive spectrum of disease. WHO will issue a call for applications to add IVD test categories
to the next edition of the EDL in mid-2018. The call will request applicants to provide information on
clinical accuracy or impact of the proposed IVDs. The first EDL will be expanded significantly over the
next few years, incorporating tests for other important areas such as antimicrobial resistance,
additional NCDs, emerging pathogens, emergencies and outbreaks, and neglected tropical diseases.
It is foreseen that the EDL will be an important tool to increase access to appropriate, affordable,
and quality-assured IVDs, particularly where they are most needed to address health priorities.

Relationship between the EDL and List of Prequalified In Vitro Diagnostics

It should be noted that the EDL and PQ List are complementary and distinct. The PQ lists include
priority IVDs which have been assessed by WHO and are identified by brand (in contrast to the EDL
which lists categories of IVDs). Currently the PQL has a narrower scope than the EDL.
Having IVDs on the PQ list is not a requirement for a category of tests to be considered for inclusion
in the EDL. In the context of the EDL, the PQ list should be viewed as a resource as it lists specific
prequalified brands of products that correspond to certain categories of tests in the EDL. Relevant
links are provided in the EDL.

11
Implementation of the EDL by countries

It will be important that Member States adopt and adapt the EDL to develop their own national
EDLs. These national EDLs will then need to be implemented to ensure impact. Implementation
requires countries to invest in integrated, connected, tiered laboratory systems, with adequate
human resources, training, laboratory infrastructure, and regulatory and quality assurance systems.

Glossary
Essential diagnostics: Diagnostics that satisfy the priority health care 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; similar to the definition of an essential medicine.

Health care facility with laboratory support: District, regional, provincial or specialized
hospitals/laboratories and national reference laboratories. Trained laboratory technicians, specialist
expertise and laboratory infrastructure/equipment are available at the appropriate level. Note: All
diagnostic tests available at the primary care level are assumed to be available at higher levels as
appropriate.

In vitro diagnostics: A subset of medical devices, 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, test kits, etc.3

Medical device: Any article, apparatus, instrument, machine, appliance, implant, reagent for in vitro
use, software, material or other similar related articles, intended to be used, alone or in
combination, for human beings, for one or more of the specific medical purpose(s) of:

 diagnosis, prevention, monitoring, treatment or alleviation of disease;

 diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
 investigation, replacement, modification, or support of the anatomy or of a physiological
process;
 supporting or sustaining life;
 control of conception;
 disinfection of medical devices;
 providing information by means of in vitro examination of specimens derived from the
human body;

and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, in or on the human body, but which may be assisted in its intended function by such means.

Primary health care: Health centres, doctors’ offices, health posts, outreach clinics. Typically, self-
testing and rapid diagnostics tests are available, but there are either no laboratories, or small
laboratories with trained health care personnel but no trained laboratory technicians.

3
Global Harmonization Task Force (2012). Definition of the terms medical device and in vitro diagnostic (IVD)
medical device (http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n071-2012-definition-of-
terms-120516.pdf#search, accessed 3 May 2018).

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Acronyms
AMR antimicrobial resistance
EDL World Health Organization Model List of Essential In Vitro Diagnostics
EML World Health Organization Model List of Essential Medicines
GPW WHO General Programme of Work
IVDs in vitro diagnostics
NCDs noncommunicable diseases
PQ WHO Prequalification
SAGE-IVD Strategic Advisory Group of Experts on In Vitro Diagnostics
TB Mycobacterium tuberculosis
WHO World Health Organization

References
Additional materials to assist countries in the selection and implementation of IVDs can be found on
the WHO website (www.who.int). These include, but are not limited to:

Guidance for procurement of in vitro diagnostics and related laboratory items and equipment.
Second edition. Geneva: World Health Organization; 2017
(http://www.who.int/diagnostics_laboratory/publications/procurement/en/).

WHO Global model regulatory framework for medical devices including in vitro diagnostic medical
devices. WHO Medical device technical series. Geneva: World Health Organization; 2017
(http://www.who.int/medical_devices/publications/global_model_regulatory_framework_meddev/e
n/).

Consultation on technical and operational recommendations for clinical laboratory testing

harmonization and standardization. Geneva: World Health Organization; 2008
(http://www.who.int/healthsystems/round9_9.pdf).

Global Health Observatory data data. Geneva: World Health Organization; 2017
(http://www.who.int/gho/en/).

WHO guide for the stepwise laboratory improvement process towards accreditation in the African
Region (SLIPTA). Brazzaville: WHO Regional Office for Africa; 2015.
(http://www.afro.who.int/publications/who-guide-stepwise-laboratory-improvement-process-
towards-accreditation-slipta-african).

Laboratory quality standards and their implementation. WHO Regional Office for the Western Pacific
and WHO Regional Office for South-East Asia; 2011
(http://www.who.int/medical_devices/publications/lab_quality_standards/en/).

Guide for national public health laboratory networking to strengthen integrated disease surveillance
and response (IDSR). Brazzaville: WHO Regional Office for Africa; 2008
(http://www.afro.who.int/publications/guide-national-public-health-laboratory-networking-
strengthen-integrated-disease).

Guidance for development of national laboratory strategic plans. Brazzaville: WHO Regional Office
for Africa and Atlanta (Georgia): United States Centers for Disease Control and Prevention (CDC);
2009 (http://www.who.int/hiv/amds/amds_guide_dev_nat_lab_strat.pdf).

13
Guidance for procurement of in vitro diagnostics and related laboratory items and equipment.
Geneva: World Health Organization; 2017
(http://www.who.int/diagnostics_laboratory/publications/procurement/en/).

WHO expert meeting report on short, medium and longer term product development priorities in
HIV-related diagnostics. Geneva: World Health Organization; 2012
(http://www.who.int/hiv/pub/meetingreports/hiv_diagnostics/en/).

Interagency list of priority medical devices for essential interventions for reproductive, maternal,
newborn and child health; 2015
(http://www.who.int/medical_devices/publications/interagency_med_dev_list/en/).

WHO list of priority medical devices for cancer management; 2017

(http://www.who.int/medical_devices/publications/priority_med_dev_cancer_management/en/ ).

WHO publications on medical devices. Geneva: World Health Organization; 2018

(http://www.who.int/medical_devices/publications/en/).

14
 List of Essential In Vitro Diagnostics (EDL)

The first edition of the EDL is presented by health care facility level in two tiers:
I Primary health care; with section a for general IVDs; and section b for specific diseases
II Health care facilities with clinical laboratories, with section a for general IVDs; and section b for specific diseases,
As follows:

I List of Essential In Vitro Diagnostics (EDL): For primary health care

Includes IVDs for health posts, community health centres, doctors’ offices, outreach clinics and ambulatory care.
Typically, self-testing and rapid diagnostics tests are available, but there are either no laboratories, or only small laboratories with trained health
care personnel but no trained laboratory technicians.
In case laboratory facilities are available in a primary health care facility, please refer to the IVDs described in the next tier.
It should be noted that in some cases sampling can take place where there are no laboratories, and then processed in the next tier.

I.a General IVDs for primary health care

Note: See list of WHO supporting documents at the end.
Diagnostic test Test purpose Assay format Specimen type

Haematology Haemoglobin (Hb) Diagnosis and monitoring of anaemia Haemoglobinometer Capillary whole blood
Key clinical marker for severe infections (i.e. malaria, dengue, Venous whole blood
VHFs) Serum
Safety monitoring when using certain drugs (e.g. Zidovudine Plasma
for HIV)
Dipstick Urine
White blood cell Surrogate marker for certain infections, inflammation or Haematology analyser Capillary whole blood
count certain cancers (e.g. leukaemia) Venous whole blood
CBC manual (only as To detect anaemia, infections and leukaemia Haemocytometer (to Capillary whole blood
back-up to measure WBC) and Wright, Venous whole blood
automated method) May-Grünwald or Giemsa
stain (for differential
detection of parasites,
malignant cells)
Peripheral blood film Capillary whole blood
examination Venous whole blood

15
I.a General IVDs for primary health care
Note: See list of WHO supporting documents at the end.
Diagnostic test Test purpose Assay format Specimen type

Clinical chemistry and Albumin To detect/monitor malnutrition, liver or kidney disease Dipstick Urine
immunoassays Bilirubin To detect/monitor liver disease, liver/pancreas and bile duct Dipstick Urine
disorders, and red cell destruction
Glucose To diagnose and screen for diabetes and intermediate Dipstick Capillary whole blood
hypoglycaemia Urine
Glucometer Capillary whole blood
Haemoglobin A1c Diagnosis and monitoring of diabetes mellitus Handheld and small analyser Capillary whole blood
(HbA1c)
Whole blood lactate To assess metabolic acidosis, diabetic keto-acidosis, sepsis and Electro-analytical method Arterial whole blood
dehydration Handheld analyser Venous whole blood
Blood transfusion Blood typing To determine blood compatibility for blood transfusions; Rh Antisera for agglutination Capillary whole blood
typing for pregnant women Venous whole blood
Serology Human chorionic Pregnancy Dipstick Urine
gonadotropin (hCG)
Microbiology, Urine dipstick and Detection of UTIs (dipstick) and identification of red and white Multi-parameter strips (dipstick) Urine
mycology and urine microscopy blood cells, casts, squamous epithelial cells, bacteria, yeast, and light microscopy
parasitology Schistosoma haematobium and other cellular components
(microscopy)
Microscopy Microbial morphology, presence/absence of white blood cells Microscopic examination of slides Disease appropriate
versus squamous epithelial cells for presumptive identification as wet preparations or which specimens (e.g.
have been treated with a variety venous whole blood,
of organism-specific chemical urine, stool, etc.)
stains (e.g. Gram stain)

16
I.b Disease-specific IVDs for primary health care
Diagnostic test Test purpose Assay format Specimen type WHO prequalified or WHO supporting documents
endorsed products
Hepatitis B Hepatitis B Screening for acute RDT Oral fluid http://www.who.int/di Guidelines on hepatitis B and C testing (February
surface antigen and chronic Capillary whole blood agnostics_laboratory/e 2017):
(HBsAg) hepatitis B (HBV) valuations/pq- http://apps.who.int/iris/bitstream/handle/10665/25
infection: infants list/hbsag/public_repor 4621/9789241549981-eng.pdf?sequence=1
over 12 months of t/en/
age, children,
adolescents, adults
Hepatitis B e Staging to assess RDT Capillary whole blood N/A
antigen (HBeAg) the need for HBV
treatment in
chronic HBV
infection
Hepatitis C Antibodies to Screening for HCV RDT Oral fluid http://www.who.int/di Guidelines on hepatitis B and C testing (February
HCV infection: infants Capillary whole blood agnostics_laboratory/e 2017):
(anti-HCV) over 18 months of valuations/pq- http://apps.who.int/iris/bitstream/handle/10665/25
age, children, list/hcv/public_report/e 4621/9789241549981-eng.pdf?sequence=1
adolescents, adults n/
HIV Antibodies to HIV HIV self-testing RDT Oral fluid http://www.who.int/di Guidelines on HIV self-testing and partner
1/2 (anti-HIV) test Capillary whole blood agnostics_laboratory/e notification (2016)
valuations/pq-list/self- http://apps.who.int/iris/bitstream/handle/10665/25
testing_public- 1655/9789241549868-eng.pdf?sequence=1
report/en/ Consolidated guidelines on HIV testing services (July
2015) http://www.who.int/hiv/pub/guidelines/hiv-
For the diagnosis of RDT Oral fluid testing-services/en/
HIV infection: Capillary whole blood WHO implementation tool for pre-exposure
adults, adolescents, prophylaxis (PrEP) of HIV infection, module 10 for
children and infants testing providers (2017)
over 18 months of http://www.who.int/hiv/pub/prep/prep-
age
implementation-tool/en/

17
I.b Disease-specific IVDs for primary health care
Diagnostic test Test purpose Assay format Specimen type WHO prequalified or WHO supporting documents
endorsed products
HIV Combined HIV For the diagnosis of RDT Oral fluid http://www.who.int/di Consolidated guidelines on HIV testing services (2015)
antibody/p24 HIV infection: adults, Capillary whole blood agnostics_laboratory/e http://www.who.int/hiv/pub/guidelines/hiv-testing-
antigen (anti- adolescents, children valuations/pq-list/hiv- services/en/
HIV/p24 Ag) test and infants over 18 rdts/public_report/en/
months of age
Malaria Plasmodium spp. For diagnosis of one RDT Capillary whole blood http://www.who.int/di WHO guidelines for the treatment of malaria, third
antigens; species or more human agnostics_laboratory/e edition (2015)
specific (e.g. HRP2) malaria species (P. valuations/pq- http://apps.who.int/iris/bitstream/10665/162441/1/9
and/or pan-species falciparum, P. vivax, P. list/malaria/public_rep 789241549127_eng.pdf
specific (e.g. pan- malariae, ort/en/
pLDH) P. ovale) Malaria rapid diagnostic test performance. Results of
WHO product testing of malaria RDTs: Round 7 (2015–
2016)
http://www.who.int/malaria/publications/atoz/97892
4151268/en/

WHO good practices for selecting and procuring rapid

diagnostic tests for malaria (2011)
http://apps.who.int/iris/bitstream/handle/10665/445
30/9789241501125_eng.pdf?sequence=1
Plasmodium spp. For diagnosis of one Light Capillary whole blood N/A WHO guidelines for the treatment of malaria, third
or more human microscopy edition (2015)
malaria species (if good http://apps.who.int/iris/bitstream/10665/162441/1/9
(P. falciparum, quality 789241549127_eng.pdf
P. vivax, P. malariae, microscopy
P. ovale and P. available) Basic malaria microscopy Part I: Learner’s guide (2010)
knowlesi) and http://apps.who.int/iris/bitstream/handle/10665/442
monitoring response 08/9789241547826_eng.pdf?sequence=1
to treatment
Malaria microscopy standard operating procedures
(2015)
http://www.wpro.who.int/mvp/lab_quality/mm_sop/
en/

18
I.b Disease-specific IVDs for primary health care
Diagnostic test Test purpose Assay format Specimen type WHO prequalified or endorsed WHO supporting documents
products
(all TB tests are evaluated and
guidelines developed through the
WHO Global TB Programme)
Tuberculosis Mycobacterium For the diagnosis Microscopy Sputum Implementing tuberculosis Compendium of WHO guidelines and associated
tuberculosis and treatment diagnostics: Policy framework standards: Ensuring optimum delivery of the cascade
bacteria monitoring of active (2015) of care for patients with tuberculosis (2017)
TB http://apps.who.int/iris/bitstre http://apps.who.int/iris/bitstream/handle/10665/25
am/10665/162712/1/9789241 9180/9789241512572-eng.pdf?sequence=1
508612_eng.pdf
Implementing tuberculosis diagnostics: Policy
For the diagnosis of LAMP Sputum The use of loop-mediated framework (2015)
active TB isothermal amplification (TB- http://apps.who.int/iris/bitstream/10665/162712/1/
LAMP) for the diagnosis of 9789241508612_eng.pdf
pulmonary tuberculosis: Policy
guidance (2016)
http://apps.who.int/iris/bitstre
am/10665/249154/1/9789241
511186-eng.pdf?ua=1
Immune For the diagnosis of Intradermal N/A Latent TB infection: Updated
response latent TB infection skin test (TST) and consolidated guidelines for
programmatic management
(2018)
http://apps.who.int/iris/bitstre
am/handle/10665/260233/978
9241550239-
eng.pdf;jsessionid=6D1BB2463
12B378ACFEBF9BFFAFEB0ED?s
equence=1

19
I.b Disease-specific IVDs for primary health care
Diagnostic test Test purpose Assay format Specimen type WHO prequalified or endorsed WHO supporting documents
products
Syphilis Antibodies to For the diagnosis or RDT Capillary whole http://www.who.int/diagnostic WHO laboratory diagnosis of sexually transmitted
Treponema as an aid in the blood s_laboratory/evaluations/PQ_li infections, including human immunodeficiency virus
pallidum diagnosis of T. st/en/ (2013)
pallidum http://apps.who.int/iris/bitstream/handle/10665/85
343/9789241505840_eng.pdf?sequence=1
Combined For diagnosis or as RDT Capillary whole http://www.who.int/diagnostic WHO Information note on the use of dual
antibodies to T. an aid in the blood s_laboratory/evaluations/pq- HIV/syphilis rapid diagnostic tests (RDT) (2017)
pallidum and to diagnosis of HIV-1/2 list/hiv-rdts/public_report/en/ http://apps.who.int/iris/bitstream/handle/10665/25
HIV-1/2 (anti-HIV) and/or T. pallidum 2849/WHO-RHR-17.01-eng.pdf?sequence=1

20
 I.2 List of Essential In Vitro Diagnostics (EDL): For health care facilities with clinical laboratories
This list includes district, regional, provincial or specialized hospitals or laboratories and national reference laboratories.
Trained laboratory technicians, specialist expertise and laboratory infrastructure/equipment are available at the appropriate level.
Note: All diagnostic tests available at the primary care level are assumed to be available at higher levels as appropriate.
The list includes: section a for general laboratory equipment; and section b tests for specific diseases.

II.a General IVDs for health care facilities with clinical laboratories
Note: See list of WHO supporting documents at the end.
Diagnostic test Test purpose Assay format Specimen type

Clinical Alanine amino- To assess liver function Optical and electro-analytical methods Serum
chemistry and transferase (ALT) (often done with AST) Plasma
immunoassays
Albumin To detect/monitor malnutrition, liver or kidney disease Photometric, turbidimetric and Urine
nephelometric testing Serum
Plasma
Alkaline phosphatase To detect/monitor malnutrition, Paget's disease or certain Colorimetric testing Serum
malignancies, including liver cancer Plasma
Aspartate amino- To assess of liver function Optical and electro-analytical methods Serum
transaminase (AST) (often done with ALT) Plasma
Bilirubin To detect/monitor liver disease, liver/pancreas and bile duct Optical and electro-analytical methods Serum
disorders, and red cell destruction Plasma
Blood pH and gases To assess lung function, metabolic or kidney disorders, and Electro-analytical methods, including Arterial whole blood
monitor oxygen therapy portable analysers Venous whole blood
Measurement of blood pH, oxygen and carbon dioxide
Blood urea nitrogen To assess kidney function and disease Optical and electro-analytical methods Serum
(BUN) Plasma
Creatinine To estimate glomerular filtration rate (eGFR) and urine Optical and electro-analytical methods Serum
albumin/creatinine ratio Urine
Key clinical marker for management of severe infections (i.e.
sepsis, Lassa fever), as well as antimicrobial regimen adjustment
Electrolytes To monitor organ damage and electrolyte alterations Optical and electro-analytical methods Serum
Plasma

21
II.a General IVDs for health care facilities with clinical laboratories
Note: See list of WHO supporting documents at the end.
Diagnostic test Test purpose Assay format Specimen type

Clinical Glucose To diagnose and screen for diabetes and intermediate Automated analyser Plasma
chemistry and hypoglycaemia Serum
immunoassays Haemoglobin A1c Diagnosis and monitoring of diabetes mellitus ELISA Capillary venous blood
(HbA1c) Automated analyser Venous whole blood

C-reactive protein To detect inflammation as an indicator of various conditions (e.g. RDT Venous whole blood
(CRP) cardiovascular disease [CVD] – high sensitivity CRP required, EIA Serum
sepsis) Plasma
Lipid profile To assess risk of developing type 2 diabetes and CVD by measuring Colourimetry Plasma
cholesterol, triglycerides and lipoproteins Spectrophotometry Serum
Basic metabolic panel Includes glucose, sodium chloride, carbon dioxide, BUN, Photometric and colourimetric testing, ion- Venous whole blood
(BMP) BUN/creatinine ratio and may include calcium selective potentiometry Serum
(8-parameter automated clinical chemistry Plasma
analyser)
Comprehensive BMP plus magnesium, protein, albumin, globulin, alb/glob ratio, As with BMP Venous whole blood
metabolic panel bilirubin (direct or total), alkaline phosphatase, ALT/AST, eGFR (14 or more parameter automated clinical Serum
chemistry analyser) Plasma
Amylase and lipase To assess acute pancreatitis Colourimetric and photometric analysers Serum
Urine
Peritoneal fluid (Amylase)
Troponin T/I For the diagnosis of myocardial infarction Enzyme immunoassay (handheld or large Venous whole blood
automated instrument) Plasma
Urinalysis Detection of substances or cellular material in the urine associated Automated chemical analyser Urine
with metabolic disorders, renal dysfunction or UTIs
Blood Blood cross-matching To determine blood compatibility for blood transfusions; Rh typing Antisera for agglutination Venous whole blood
transfusion for pregnant women
Transfusion To screen for Chagas, HTLV in the blood supply etc. (see also EDL EIA (microplate) Serum
transmitted infections sections on HIV, hepatitis C, hepatitis B, syphilis) Manual method Plasma
CLIA/ECL (automated instrument) Serum
Plasma
Serology Human chorionic Pregnancy Optical method Serum
gonadotropin (hCG)

22
II.a General IVDs for health care facilities with clinical laboratories
Note: See list of WHO supporting documents at the end.
Diagnostic test Test purpose Assay format Specimen type

Microbiology, Urine dipstick and Detection of UTIs (dipstick) and identification of red and white Multi-parameter strips (dipstick) and light Urine
mycology and urine microscopy blood cells, casts, squamous epithelial cells, bacteria, yeast, microscopy
parasitology Schistosoma haematobium and other cellular components
(microscopy)
Culture Initial step in the process of bacterial species detection and Culture on growth media plates and Disease appropriate
identification to support selection of appropriate antibiotic incubator followed by recovery of isolates specimens (e.g. venous
treatment regimens and speciation (traditional manual whole blood, urine, stool,
techniques or automated equipment) etc.)
Blood culture For the diagnosis of bacterial and fungal blood stream infections Blood culture bottle and incubator followed Venous whole blood
(sepsis) by recovery of isolates and speciation
(traditional manual techniques or automated
equipment)
Antimicrobial Final step in the process of selection of appropriate antibiotic Antimicrobial susceptibility testing of isolates Microbial isolates
susceptibility testing treatment regimens after species identification – may be done manually using disc diffusion
technique or using automated platforms
Haematology Haematocrit (Ht) Diagnosis and monitoring of anaemia Microhaematocrit centrifuge Capillary or venous whole
Volume of red blood cells as a percentage of total blood volume blood
Prothrombin time To detect/diagnose a bleeding disorder or excessive clotting Handheld or automated coagulation analyser Citrate plasma
test and international disorder (PT); monitor performance of anticoagulant medications
normalized ratio (INR)
(PT/INR)
Platelet count Diagnosis of thrombocytopenia Haemocytometer Capillary whole blood
Marker to manage severe infections associated with bleeding and Haematology analyser Venous whole blood
sepsis (i.e. VHF, meningococcemia) and certain haematological Flow cytometer Venous whole blood
disorders
Complete blood Evaluation of patient’s overall health and to detect a wide range of Automated hematology analyser (WBC, RBC, Venous whole blood
count (CBC) disorders, including anaemia, infection and leukaemia platelets, Hb and Ht) includes lymphocytes,
Automated, monocytes and granulocytes (for three-part
differential differential)

23
II.b Disease-specific IVDs for health care facilities with clinical laboratories

Diagnostic test Test purpose Assay format Specimen type WHO prequalified or endorsed WHO supporting documents
products
Hepatitis B Hepatitis B surface Screening for acute and RDT Venous whole blood http://www.who.int/diagnostic Guidelines on hepatitis B and C
antigen (HBsAg) chronic hepatitis B (HBV) Plasma s_laboratory/evaluations/pq- testing (February 2017)
infection: infants over 12 Serum list/hbsag/public_report/en/ http://apps.who.int/iris/bitstream/ha
months of age, children, ndle/10665/254621/9789241549981-
adolescents, adults eng.pdf?sequence=1
Virological Staging to assess the NAT Serum
(HBV DNA – need for HBV treatment Plasma
quantitative) in chronic HBV infection
and monitoring of
response to treatment
Hepatitis B e antigen Staging to assess the EIA Serum N/A
(HBeAg) need for HBV treatment Plasma
in chronic HBV infection
CLIA Serum N/A
Plasma
IgM-specific For the diagnosis of acute EIA (microplate) Serum N/A
antibodies to HBV infection – used for Manual method Plasma
hepatitis B core outbreak investigation
CLIA/ECL Serum N/A
antigen (IgM anti-
(automated Plasma
HBc)
instrument)

Antibodies to Determining EIA (microplate) Serum N/A

hepatitis B surface effectiveness of HBV Manual method Plasma
antigen (anti-HBs) immunization at patient
and at a population level
Also used as a marker for CLIA/ECL Serum N/A
recovery from HBV (automated Plasma
infection instrument)

24
II.b Disease-specific IVDs for health care facilities with clinical laboratories
Diagnostic test Test purpose Assay format Specimen type WHO prequalified or endorsed WHO supporting documents
products
Hepatitis C Antibodies to HCV Screening for HCV RDT Venous whole blood http://www.who.int/diagnostic Guidelines on hepatitis B and C
(anti-HCV) infection: infants over 18 Plasma s_laboratory/evaluations/pq- testing (February 2017)
months of age, children, Serum list/hcv/public_report/en/ http://apps.who.int/iris/bitstream/h
adolescents, adults EIA (microplate) Serum andle/10665/254621/978924154998
Manual method Plasma 1-eng.pdf?sequence=1
CLIA/ECL Serum
(automated Plasma
instrument)
Antibodies to HCV Screening for HCV past or EIA (microplate) Serum
(anti-HCV) and HCV present infection: infants Manual method Plasma
core antigen (HCV over 18 months of age, CLIA/ECL Serum
cAg) children, adolescents, (automated Plasma
adults instrument)
HCV core antigen For the diagnosis of CLIA/ECL Serum
(HCV cAg) viraemic HCV infection (automated Plasma
instrument)
HCV RNA (qualitative For the diagnosis of NAT Serum
or quantitative) viraemic HCV infection Plasma
and monitoring of
response to treatment as
a test of cure

25
II.b Disease-specific IVDs for health care facilities with clinical laboratories
Diagnostic test Test purpose Assay format Specimen type WHO prequalified or endorsed WHO supporting documents
products
HIV Antibodies to HIV-1/2 For the diagnosis of HIV RDT Venous whole blood http://www.who.int/diagnostic Guidelines on HIV self-testing and partner
(anti-HIV) test infection: adults, Plasma s_laboratory/evaluations/pq- notification (2016)
adolescents, children and Serum list/self-testing_public- http://apps.who.int/iris/bitstream/handle/
infants over 18 months of report/en/ 10665/251655/9789241549868-
age eng.pdf?sequence=1
EIA (microplate) Serum Consolidated guidelines on HIV testing
Manual method Plasma services (July 2015)
CLIA/ECL Serum http://www.who.int/hiv/pub/guidelines/hi
(automated Plasma v-testing-services/en/
instrument)
WHO implementation tool for pre-
exposure prophylaxis (PrEP) of HIV
infection, module 10 for testing providers
(2017)
http://www.who.int/hiv/pub/prep/prep-
implementation-tool/en/
For screening for HIV in EIA (microplate) Serum N/A Screening donated blood for transfusion
the blood supply and in Manual method Plasma transmissible infections: Recommendations
blood products CLIA/ECL Serum (2009)
(automated Plasma http://apps.who.int/iris/bitstream/handle/
instrument) 10665/44202/9789241547888_eng.pdf?se
quence=1&isAllowed=y
Combined HIV For the diagnosis of HIV RDT Venous whole blood http://www.who.int/diagnostic Consolidated guidelines on HIV testing
antibody/p24 antigen infection: adults, Plasma s_laboratory/evaluations/pq- services (2015)
(anti-HIV/p24 Ag) test adolescents, children and Serum list/hiv-rdts/public_report/en/ http://apps.who.int/iris/bitstream/handle/
infants over 18 months of EIA (microplate) Serum 10665/179870/9789241508926_eng.pdf?s
age Manual method Plasma equence=1
CLIA/ECL Serum
(automated Plasma
instrument)
For screening for HIV in EIA (microplate) Serum N/A Screening donated blood for transfusion
the blood supply and in Manual method Plasma transmissible infections: Recommendations
blood products CLIA/ECL Serum (2009)http://apps.who.int/iris/bitstream/h
(automated Plasma andle/10665/44202/9789241547888_eng.
instrument) pdf?sequence=1&isAllowed=y

26
II.b Disease-specific IVDs for health care facilities with clinical laboratories

Diagnostic test Test purpose Assay format Specimen type WHO prequalified or endorsed WHO supporting documents
products

HIV HIV qualitative For the diagnosis of HIV NAT Capillary whole blood http://www.who.int/diagnostic Consolidated guidelines on the use of
virological or infection in infants under Venous whole blood s_laboratory/evaluations/pq- antiretroviral drugs for treating and
quantitative 18 months of age Dried blood spot list/hiv-vrl/public_report/en/ preventing HIV infection (2016)
virological Serum http://www.who.int/hiv/pub/arv/arv-
Plasma 2016/en/
HIV quantitative Monitoring of response NAT Dried blood spot http://www.who.int/diagnostic
virological to antiviral treatment Serum s_laboratory/evaluations/pq-
Plasma list/hiv-vrl/public_report/en/
CD4 cell enumeration For staging of advanced Flow cytometry Capillary whole blood http://www.who.int/diagnostic
(quantitative) HIV disease Venous whole blood s_laboratory/evaluations/pq-
list/hiv-vrl/public_report/en/

Cryptococcal antigen For screening and RDT CSF N/A Guidelines for the diagnosis, prevention,
test diagnosis of cryptococcal Venous whole blood and management of cryptococcal disease
meningitis in people living Serum in HIV-infected adults, adolescents and
with advanced HIV Plasma children (2018)
disease EIA CSF http://apps.who.int/iris/bitstream/handle/
Serum 10665/260399/9789241550277-
Plasma eng.pdf?sequence=1

27
II.b Disease-specific IVDs for health care facilities with clinical laboratories
Diagnostic test Test purpose Assay format Specimen type WHO prequalified or endorsed WHO supporting documents
products
Malaria Plasmodium spp. For diagnosis of one or RDT Capillary whole blood http://www.who.int/diagnostic WHO guidelines for the treatment of
antigens; species more human malaria Venous whole blood s_laboratory/evaluations/pq- malaria, third edition (2015)
specific (e.g. HRP2) species (P. falciparum, P. list/malaria/public_report/en/ http://apps.who.int/iris/bitstream/10665/
and/or pan-species vivax, P. malariae, P. 162441/1/9789241549127_eng.pdf
specific (e.g. pan- ovale)
pLDH) Malaria rapid diagnostic test performance:
Results of WHO product testing of malaria
RDTs: Round 7 (2015–2016)
http://www.who.int/malaria/publications/
atoz/978924151268/en/

WHO good practices for selecting and

procuring rapid diagnostic tests for malaria
(2011)
http://apps.who.int/iris/bitstream/handle/
10665/44530/9789241501125_eng.pdf?se
quence=1

Plasmodium spp. For diagnosis of one or Light microscopy Capillary whole blood N/A WHO guidelines for the treatment of
more human malaria Venous whole blood malaria, third edition (2015)
species (P. falciparum, P. http://apps.who.int/iris/bitstream/10665/
vivax, P. malariae, P. 162441/1/9789241549127_eng.pdf
ovale and P. knowlesi)
and monitoring response Basic malaria microscopy Part I: Learner’s
to treatment guide (2010)
http://apps.who.int/iris/bitstream/handle/
10665/44208/9789241547826_eng.pdf?se
quence=1

Malaria microscopy standard operating

procedures (2015)
http://www.wpro.who.int/mvp/lab_quality
/mm_sop/en/

28
II.b Disease-specific IVDs for health care facilities with clinical laboratories

Diagnostic test Test purpose Assay format Specimen type WHO prequalified or endorsed WHO supporting documents
products

Malaria Glucose-6-phosphate To determine G6PD Semi quantitative Venous whole blood http://www.who.int/diagnostic Beutler E, Blume KG, Kaplan JC, Lohr GW,
dehydrogenase activity (normal, fluorescent spot s_laboratory/evaluations/pq- Ramot B, Valentine WN. International
activity (G6PD) intermediate, deficient) test list/malaria/public_report/en/ Committee for Standardization in
and specifically to inform Haematology: Recommended screening
decision to administer 8- test for glucose-6-phosphate
aminoquinoline group dehydrogenase deficiency. Br J Haematol
drugs for radical cure of 1979;43:469–477
P. vivax WHO guidelines for the treatment of
For screening newborns malaria, third edition (2015)
for G6PD deficiency http://apps.who.int/iris/bitstream/10665/
162441/1/9789241549127_eng.pdf

29
II.b Disease-specific IVDs for health care facilities with clinical laboratories
Diagnostic test Test purpose Assay format Specimen type WHO prequalified or endorsed products WHO supporting documents
(all TB tests are evaluated and guidelines developed
through the WHO Global TB Programme)
Tuberculosis Mycobacterium For the diagnosis Microscopy Other Implementing tuberculosis diagnostics: Policy Compendium of WHO guidelines and
tuberculosis and treatment specimen types framework (2015) associated standards: Ensuring optimum
bacteria monitoring of active http://apps.who.int/iris/bitstream/10665/162712/1 delivery of the cascade of care for
TB /9789241508612_eng.pdf patients with tuberculosis (2017)
For the diagnosis Bacterial Sputum or http://apps.who.int/iris/bitstream/handle
and treatment culture other specimen /10665/259180/9789241512572-
monitoring of active types eng.pdf?sequence=1
TB including drug-
resistant TB Implementing tuberculosis diagnostics:
M. tuberculosis For the diagnosis of Cartridge-based Sputum or WHO Meeting report of a technical expert Policy framework (2015)
DNA active TB and NAT EPTB specimen consultation: Non-inferiority analysis of Xpert http://apps.who.int/iris/bitstream/10665
simultaneous types MTB/RIF Ultra compared to Xpert MTB/RIF (2017) /162712/1/9789241508612_eng.pdf
detection of http://apps.who.int/iris/bitstream/handle/10665/2
rifampicin 54792/WHO-HTM-TB-2017.04-
resistance eng.pdf;jsessionid=E02D0994930EDBD9A4BC5BB3D
3A28568?sequence=1

Automated real-time nucleic acid amplification

technology for rapid and simultaneous detection of
tuberculosis and rifampicin resistance: Policy
update (2013)
http://apps.who.int/iris/bitstream/10665/112472/1
/9789241506335_eng.pdf
M. tuberculosis For the detection of Molecular LPA Sputum The use of molecular line probe assays for the
DNA mutations resistance for first- detection of resistance to isoniazid and rifampicin:
associated with line anti-TB Policy update (2016)
resistance medicines http://apps.who.int/iris/bitstream/10665/250586/1
/9789241511261-eng.pdf?ua=1
M. tuberculosis For the detection of Molecular LPA Sputum The use of molecular line probe assays for the
DNA mutations resistance for detection of resistance to second-line anti-
associated with second-line anti-TB tuberculosis drugs: Policy update (2016)
resistance medicines http://apps.who.int/iris/bitstream/handle/10665/2
46131/9789241510561-eng.pdf?sequence=1

30
II.b Disease-specific IVDs for health care facilities with clinical laboratories

Diagnostic test Test purpose Assay format Specimen type WHO prequalified or endorsed products WHO supporting documents
(all TB tests are evaluated and guidelines developed
through the WHO Global TB Programme)
Tuberculosis M. tuberculosis To detect resistance DST Bacterial Technical report on critical concentrations for drug
culture-based to first-line and/or culture of M. susceptibility testing of medicines used in the
DST second-line anti-TB tuberculosis treatment of drug-resistant tuberculosis (2018)
medicines http://www.who.int/tb/publications/2018/WHO_te
chnical_report_concentrations_TB_drug_susceptibil
ity/en/
Lipoarabino- To aid in the RDT Urine The use of lateral flow urine lipoarabinomannan
mannan (LAM) diagnosis of TB in assay (LF-LAM) for the diagnosis and screening of
antigen seriously ill HIV- active tuberculosis in people living with HIV: Policy
positive inpatients update (2015)
http://apps.who.int/iris/bitstream/handle/10665/1
93633/9789241509633_eng.pdf;jsessionid=9A9EB8
86DC17658BF7FDF86758D7A9F9?sequence=1
Immune For the diagnosis of IGRA Venous whole Latent TB Infection: Updated and consolidated
response latent TB infection blood guidelines for programmatic management (2018)
http://apps.who.int/iris/bitstream/handle/10665/2
60233/9789241550239-
eng.pdf;jsessionid=6D1BB246312B378ACFEBF9BFFA
FEB0ED?sequence=1

31
II.b Disease-specific IVDs for health care facilities with clinical laboratories
Diagnostic test Test purpose Assay format Specimen type WHO prequalified or endorsed products WHO supporting documents

HPV Human For cervical cancer Nucleic acid test Cervical cells http://www.who.int/diagnostics_laboratory/ WHO human papillomavirus laboratory
papillomavirus screening collected in test evaluations/pq-list/public_report_hpv/en/ manual, first edition (2009)
(HPV) DNA specific transport http://apps.who.int/iris/bitstream/handl
fluid e/10665/70505/WHO_IVB_10.12_eng.pd
f?sequence=1
Syphilis Antibodies to For diagnosis or as an RDT Venous whole blood http://www.who.int/diagnostics_laboratory/ WHO laboratory diagnosis of sexually
Treponema aid in the diagnosis of Plasma evaluations/PQ_list/en/ transmitted infections, including human
pallidum T. pallidum Serum immunodeficiency virus (2013)
EIA (Microplate) Serum http://apps.who.int/iris/bitstream/handl
Manual method Plasma e/10665/85343/9789241505840_eng.pd
CLIA/ECL Serum f?sequence=1
(automated Plasma
instrument)
For screening blood EIA (Microplate) Serum N/A Screening donated blood for transfusion
and blood products Manual method Plasma transmissible infections (2009)
http://apps.who.int/iris/bitstream/handl
e/10665/44202/9789241547888_eng.pd
f?sequence=1&isAllowed=y
Combined For the diagnosis or RDT Venous whole blood http://www.who.int/diagnostics_laboratory/ WHO Information note on the use of
antibodies to T. as an aid in the Plasma evaluations/pq-list/hiv- dual HIV/syphilis rapid diagnostic tests
pallidum and to diagnosis of HIV-1/2 Serum rdts/public_report/en/ (RDT) (2017)
HIV-1/2 (anti- and/or T. pallidum http://apps.who.int/iris/bitstream/handl
HIV) e/10665/252849/WHO-RHR-17.01-
eng.pdf?sequence=1

32
WHO supporting documents for general laboratory diagnostics
Asia Pacific strategy for strengthening health laboratory services (2010–2015); 2010 (http://www.wpro.who.int/health_technology/documents/asia_pacific_laboratory_strategy2010-2015.pdf?ua=1).

Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: Recommendations for a public health approach; 2016
(http://apps.who.int/iris/bitstream/handle/10665/208825/9789241549684_eng.pdf?sequence=1).

Guidelines on hepatitis B and C testing; 2017 (http://apps.who.int/iris/bitstream/handle/10665/254621/9789241549981-eng.pdf?sequence=1).

HEARTS: Technical package for cardiovascular disease management in primary health care; 2018 (http://apps.who.int/iris/bitstream/handle/10665/260420/WHO-NMH-NVI-18.3-
eng.pdf;jsessionid=1FEE12C3923A2885107C0D9EEFBB82B0?sequence=1).

Interagency list of priority medical devices for essential interventions for reproductive, maternal, newborn and child health; 2015
(http://www.who.int/medical_devices/publications/interagency_med_dev_list/en/).

Screening donated blood for transfusion-transmissible infections: Recommendations; 2009 (http://apps.who.int/iris/bitstream/handle/10665/44202/9789241547888_eng.pdf?sequence=1&isAllowed=y).

Use of glycated haemoglobin (HbA1c) in the diagnosis of diabetes mellitus; 2011 (http://www.who.int/diabetes/publications/diagnosis_diabetes2011/en/).

WHO list of priority medical devices for cancer management; 2017 (http://www.who.int/medical_devices/publications/priority_med_dev_cancer_management/en/).

WHO Manual of basic techniques for a health laboratory, 2nd edition; 2003 (http://apps.who.int/iris/bitstream/handle/10665/42295/9241545305.pdf?sequence=1).

WHO publications on medical devices. Geneva: World Health Organization; 2018 (http://www.who.int/medical_devices/publications/en/).

33
Acronyms

ALT alanine aminotransferase

AST aspartate aminotransferase
BMP basic metabolic panel
BUN blood urea nitrogen
CBC complete blood count
CLIA chemiluminescence immunoassay
CRP C-reactive protein
CSF cerebrospinal fluid
CVD cardiovascular disease
DST drug susceptibility testing
ECL electrochemiluminescence
eGFR estimated glomerular filtration rate
EIA enzyme immunoassay
ELISA enzyme linked immunosorbent assay
EPTB extrapulmonary tuberculosis
Hb haemoglobin
HbA1c haemoglobin A1c
hCG human chorionic gonadotropin
Ht haematocrit
HTLV human T-lymphotropic virus
IGRA interferon gamma release assay
INR international normalized ratio
LAMP loop mediated isothermal amplification
LPA line probe assay
NAT nucleic acid test
PT prothrombin time
RBC red blood cell count
RDT rapid diagnostic test
UTI urinary tract infection
TST tuberculin skin test
WBC white blood cell count
VHF viral haemorrhagic fever

34
WHO References
WHO Manual of basic techniques for a health laboratory, 2nd edition; 2003
(http://apps.who.int/iris/bitstream/handle/10665/42295/9241545305.pdf?sequence=1).

Asia Pacific strategy for strengthening health laboratory services (2010–2015); 2010
(http://www.wpro.who.int/health_technology/documents/asia_pacific_laboratory_strategy2010-2015.pdf?ua=1).

Screening donated blood for transfusion-transmissible infections: Recommendations; 2009

(http://apps.who.int/iris/bitstream/handle/10665/44202/9789241547888_eng.pdf?sequence=1&isAllowed=y).

Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: Recommendations for
a public health approach; 2016
(http://apps.who.int/iris/bitstream/handle/10665/208825/9789241549684_eng.pdf?sequence=1).

Guidelines on hepatitis B and C testing; 2017 (http://apps.who.int/iris/bitstream/handle/10665/254621/9789241549981-

eng.pdf?sequence=1).

Interagency list of medical devices for essential interventions for reproductive, maternal, newborn and child health; 2015
(http://www.who.int/medical_devices/publications/interagency_med_dev_list/en/).

Use of glycated haemoglobin (HbA1c) in the diagnosis of diabetes mellitus; 2011

(http://www.who.int/diabetes/publications/diagnosis_diabetes2011/en/).

HEARTS: Technical package for cardiovascular disease management in primary health care; 2018
(http://apps.who.int/iris/bitstream/handle/10665/260420/WHO-NMH-NVI-18.3-
eng.pdf;jsessionid=1FEE12C3923A2885107C0D9EEFBB82B0?sequence=1).

WHO list of priority medical devices for cancer management; 2017

(http://www.who.int/medical_devices/publications/priority_med_dev_cancer_management/en/).

WHO publications on medical devices. Geneva: World Health Organization; 2018

(http://www.who.int/medical_devices/publications/en/).

35