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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.

WHO / TDR /Simon Lim

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

WHO / EURO /Gilles Reboux

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

Disease-specific laboratory policy and strategy

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.

66顺彩票app 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

Laboratory biosafety guidelines and support

Disease-specific testing resources

Regional laboratory setup, methods and management

IVDs in primary care

WHO/TDR /Andy Craggs

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

Quality management

WHO / EURO /Gilles Reboux

66顺彩票appEnsuring 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

WHO laboratory quality management support documents

Regulation & market approval

WHO/PAHO /Armando Waak

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

International regulatory harmonization


WHO /Sergey Volkov

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


66顺彩票appMany 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

WHO/Tom Pietrasik

Links to the professional societies with whom WHO has collaboration partnerships on IVDs, as well as foundations and NGOs involved in work on IVDs

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