TB Research

Rapid diagnostic test accessibility considerations for professional use and self-tests

World Health Organization

Abstract

This document provides accessibility considerations for the design, development and implementation of rapid diagnostic tests (RDTs) intended for professional use and self-testing. Developed by the World Health Organization through a consultative process involving technical experts, end users and organizations representing persons with disabilities, the publication addresses barriers that may limit equitable access to diagnostic technologies. The guidance applies to a broad range of rapid diagnostics, including tests for HIV, tuberculosis, malaria, SARS-CoV-2, hepatitis, syphilis and pregnancy, among others.

The publication outlines practical considerations to improve accessibility and usability across labeling, instructions for use, physical components, digital interfaces, specimen collection, result interpretation and disposal. It emphasizes principles of universal design, multimodal communication, plain language, compatibility with assistive technologies, and engagement of end users throughout product development and evaluation. The document also discusses the relevance of accessibility for WHO prequalification and post-market surveillance processes. Its objective is to support manufacturers, regulators, procurement agencies, implementing partners and donors in promoting equitable access to diagnostic testing for persons with disabilities, older adults and other populations facing barriers to health services.

MeSH terms

  • Rapid Diagnostic Tests
  • Diagnostic Tests, Routine
  • Point-of-Care Testing
  • Self-Testing
  • Health Services Accessibility
  • Health Equity
  • Health Services for Persons with Disabilities
  • Aged
  • Universal Design
  • User-Computer Interface
  • Product Labeling
  • Product Packaging
  • Software Design
  • Product Surveillance, Postmarketing
  • HIV Infections
  • Malaria, Falciparum
  • Malaria, Vivax
  • Tuberculosis
  • COVID-19
  • SARS-CoV-2
  • Syphilis
  • Hepatitis B
  • Hepatitis C
  • Pregnancy Tests
  • Urinalysis
  • Glucosephosphate Dehydrogenase Deficiency
  • Form
  • diagnosis