Resources

 

 

Health Topics

The IDC website currently focuses its resources on two health topics: HIV/AIDS and Maternal and Child Health. There are, however, many other significant health topics in global health that have implications for diagnostics in resource-limited settings. These include tuberculosis, malaria and neglected tropical diseases, among others.  Resources on important issues in diagnostics for infectious diseases and health topics other than HIV/AIDS and Maternal and Child Health can be found under Other Health Topics on this site.

Development and Evaluation

Development

In order to guide developers in product design and development of diagnostic tests, in particular those for use at or near the point of patient care, standards are needed. The standards are a set of desired operational and technical specifications for diagnostic platforms being developed for use at various levels of the laboratory system in resource-limited settings. These standards can be summarized in a Target Product Profile (TPP) that provides a clear set of minimal and optimal standards for each platform, including the device, if any, and the assay. A TPP sets forth specifications for each test platform and is generally divided into three main sections: (i) intended use; (ii) technical performance; and (iii) operational characteristics.

Evaluation

Once diagnostic products are developed, it is essential for developers to have an in-depth understanding of the evaluation process for in vitro diagnostics (IVDs) in-country in order to facilitate introduction and uptake of their products. There are currently no uniform diagnostic quality standards to guide product selection in resource-limited settings. As a result, in-country evaluations are an essential part of the development process for new IVDs. Such evaluations generally take place in two stages: (i) clinical evaluations in controlled settings in-country that test, among other things, internal consistency (precision) as well as accuracy against an appropriate reference technology, and (ii) field evaluations in-country that introduce additional variables, including the use of the product by minimally-trained lay operators.

Resources associated with these areas include:

  • TPPs for a number of specific diagnostic assays – e.g. quantitative viral load assay for HIV/AIDs
  • Links to UNITAID landscape reports, which contain descriptions of pipeline technologies.
  • General principles on how to design and conduct diagnostic evaluations
  • Standardized/generic protocols for clinical evaluations
  • A network of accredited evaluation sites in-country for various IVDs
  • Publications of test performance, including systematic reviews

Policy and Implementation

Policy

The ultimate decision to introduce new diagnostic technologies in-country rests with the ministry of health. In-country policies must accommodate the new technologies and ministries often require guidance with respect to appropriate technology placement, impact and cost-effectiveness.

Implementation

In order to achieve successful implementation and uptake of a diagnostic in-country, it is essential that developers understand the landscape and the tools to effectively coordinate these activities. A number of systems support diagnostic testing in-country. These include:

  • Supply chain
  • Human resources and training
  • Service delivery design
  • Service and maintenance
  • Quality assurance

Successful implementation of new diagnostic technologies requires that each of these systems functions well, but they are often weak or lacking in-country. For example, ineffective supply chain systems (forecasting, procurement and distribution) can lead to perennial consumable and reagent shortages. 

Shortages not only lead to costly emergency fixes, but also are detrimental to the quality of patient care. Some common diagnostic tests require not only test reagents, but also numerous associated consumables, collection supplies, and quality controls to come together at the same time to ensure a quality result.

In resource-limited settings, supply chain challenges include:

  • Remote locations – hours from major towns, poor road conditions, seasonally impassable
  • Limited infrastructure – limited electricity and access to communication
  • Paper-based recordkeeping
  • Human resources capacity

These problems are more pronounced when implementing point-of-care diagnostics, which require more devices/tests in more remote locations than centralized testing; for which it is more costly and complex to distribute reagents and consumables; and which requires procurement, forecasting and managing inventories of testing supplies at a greater number of sites.

Technology implementation challenges include managing each of these areas of weakness, including training, service/maintenance and piloting quality assurance systems. It also includes understanding and navigating the various key partners in-country, in addition to ministries of health.

Resources associated with these areas include:

  • Technology assessment and strategic placement tools
  • Models for impact assessment and cost-effectiveness
  • Sources of diagnostic and laboratory practice training
  • Quality Assurance/Quality Control materials and information on quality management of diagnostic laboratories
  • Toolkits (e.g. rapid syphilis test toolkit) and links to other toolkits
  • Links to publications on operations research

Regulation

The purpose of regulation is to protect public health by assuring the safety, effectiveness, and quality of diagnostic tests while enabling timely access to beneficial new products. 

This website contains resources on a range of regulatory topics including:

Regulation of in-vitro diagnostic devices (IVDDs)

National and regional regulatory legislation and requirements

Global and regional harmonization initiatives 

 

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