Laboratory and in vitro diagnostics
Definition of in vitro diagnostics (IVD)
In Vitro Diagnostic (IVD) tests are a subset of medical devices.
In vitro diagnostic tests are used for in vitro examination of specimens derived from the human body to provide information for screening, diagnosis, or treatment monitoring purposes.
An IVD test may include reagents provided either in kit format or separately, as well as calibrators, and controls.
In vitro testing may be performed on a variety of instruments ranging from small, hand held tests to complex laboratory instruments.
The importance of in vitro diagonostics in medicine
IVDs are essential to improve health outcomes, and are critical tools both in everyday medical practice and in emergencies.
Most treatment decisions today are based on IVD results. They ensure that the right patients receive the right treatments, thus protecting patients from incorrect, ineffective or, at worst, harmful treatments; and reducing unnecessary healthcare expenditures
Early detection and diagnosis leads to early and appropriate intervention, thereby improving patient outcomes, saving lives and the costs related to expensive late-stage care.
The development of laboratory capacity is critical for effective healthcare delivery to people around the world.
The need for laboratory capacity building to support the EDL
While the Essential Diagnostics List (EDL) includes the important tests required at various levels of the health care system, the EDL alone cannot have an impact in the absence of an integrated, connected, tiered laboratory system, with qualified laboratory personnel and primary care workers, laboratory infrastructure, and regulatory & quality management systems.
Over the last ten years, access to treatment for people living with priority diseases such as HIV/AIDS, TB and malaria has substantially increased. However, the lack of laboratory and diagnostic capacity in resource-poor settings continues to be a barrier to achieving the treatment, and disease surveillance and control targets set and endorsed by the international community.
The purpose of the WHO IVD Web Portal
WHO regularly publishes a broad range of materials relevant to in vitro diagnostics testing and laboratory capacity development, but the links to these documents have until now been scattered under various headings throughout the WHO web site.
Through this IVD web portal we aim to provide a single entry point to access these valuable resources and an extra support to countries as they develop their laboratory capacity and adapt the EDL to their local settings
Policies and strategic plans
Providing adequate laboratory services to support basic healthcare requires the implementation of a national strategy for the development of appropriate laboratory infrastructure.
WHO has resources available to assist with the development of national health lab policies, as well as strategies for strengthening lab capacity.
General laboratory policy
- Technical consultation on the development of national health laboratory policies: meeting report
- Development of medical device policies
Disease-specific laboratory policy and strategy
- Framework of indicators and targets for laboratory strengthening under the End TB Strategy
- Implementing tuberculosis diagnostics policy framework
- Role of Laboratory Detection of Human Papilloma Virus
- Protecting health through global epidemic control
Regional laboratory policy and strategy
Laboratory management
Diagnostics services in a given country depend on an integrated, connected, tiered laboratory system with laboratories of varying technical sophistication at different levels of the healthcare delivery system.
WHO documents are available offering guidance on lab set up as well as testing methods for a wide range of diseases.
Laboratory test selection and method manuals
- A guide to aid selection of diagnostic tests
- Manual of basic techniques for a health laboratory
- Basic laboratory procedures in clinical bacteriology
Laboratory biosafety guidelines and support
Disease-specific testing resources
Regional laboratory setup, methods and management
IVDs in primary care
A broad set of IVDs is available for testing patients in the primary care setting where laboratories are not available.
Evaluations of the use of various Rapid Diagnostic Tests are available from WHO
Human resources
Capacity building for training & development of lab technicians and management, is essential in order to offer reliable test results.
Several WHO regions have implemented training programmes for various laboratory skills.
Human resources capacity building
- Human resources for medical devices, the role of biomedical engineers
- Implementation of a mentored professional development programme in laboratory leadership and management in the Middle East and North Africa
- Needs assessment for strengthening laboratory human resources capacity for universal access to HIV, malaria and TB services in three Sub-Saharan African countries
- WHO list of priority medical devices for cancer management
Disease-specific training materials
- Training materials for malaria diagnostics
- Hands-on training workshop on cell culture techniques for the laboratory diagnosis of polio/enteroviruses and measles/rubella in the western pacific region
- Second TB laboratory training course for Asia Pacific
- Hands-on training/workshop on the laboratory diagnosis of measles
- Hands-on training/workshop on the laboratory diagnosis of measles virus infection
Quality management
Ensuring reliable lab results for all patients requires quality management programmes for laboratory management, for test proficiency and for the IVD tests themselves.
WHO IVD quality support programs
- Expert committee on biological standardization
- Prequalification of in vitro diagnostics
- Program for external control sample
- Quality assurance
- Laboratory quality stepwise implementation tool
WHO laboratory quality management support documents
Regulation & market approval
Reliable laboratory test results rely on commercially available tests that have been validated and shown in clinical studies to perform to a reproducibly adequate standard.
WHO web resources supporting market access for validated IVDs
- Prequalification of in vitro diagnostics
- WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices
- Post-market surveillance for in vitro diagnostics (IVDs)
- Regulations
International regulatory harmonization
Procurement and supply
WHO resources supporting procurement of IVDs
- WHO programme for procurement of IVDs
- WHO guidance for procurement of in vitro diagnostics and related laboratory items and equipment
- Maputo declaration
- Selection of basic laboratory equipment for laboratories with limited resources
Disease-specific laboratory procurement guidance
Model list of essential IVDs
WHO model list of essential diagnostics
- Selection, access and use of in vitro diagnostics
- Second WHO Model List of Essential In Vitro Diagnostics
- 2nd Meeting of the Strategic Advisory Group of Experts on IVDs
- Procedure to update the WHO Model List of In Vitro Diagnostics
- First WHO Model List of Essential In Vitro Diagnostics
Strategic advisory group of experts on in vitro diagnostics (SAGE IVD)
Disease-specific IVD resources
Identify WHO IVD documents and web pages by disease area
Innovation
In order to support innovation and product development to meet priority IVD product needs, WHO posts Target Product Profiles (TPP’s) from time to time. This section shows a compilation of TPP’s related to IVD’s.
Regional health
Many IVD-related initiatives and documents from WHO have been written by particular regions. This list is intended to help find IVD-related resources starting from the relevant region.
Regional laboratory setup, methods and management
Global collaboration
Links to the professional societies with whom WHO has collaboration partnerships on IVDs, as well as foundations and NGOs involved in work on IVDs