Testing and diagnostics are essential tools to improve health outcomes across diseases. Most treatment decisions today are based on test results. Early detection and diagnosis is often the gateway to prevention and treatment, thereby improving patient outcomes, saving lives, and the costs related to extensive, expensive, ongoing long-term care. Access to and uptake of testing services and development of diagnostic capacity is critical for effective healthcare delivery to all people around the world. Prevention and treatment of infectious diseases such as HIV, hepatitis, and sexually transmitted infections rely on testing and diagnostics to achieve global and national goals.

Several technologies, both laboratory-based and point-of-care assays (including rapid diagnostic tests and self-tests), can be used to diagnose and monitor multiple infections and diseases, including HIV and TB but also hepatitis C, human papillomavirus for cervical cancer screening, sexually transmitted infections and outbreak infections. Integrating testing using multiplex technologies (using the same technology for several assays and/or across diseases) at the appropriate level of care can lead to more efficient and cost-effective testing services.

Further, diagnostic integration can help to simplify and streamline other systems, such as specimen referral, human resources, supply chain and procurement, data management systems, and quality assurance.

However, integration will require political commitment, coordination and strategic planning. In the current climate of stagnant or shrinking funding, innovative and efficient approaches and solutions that can maximize investments, while still increasing access, will be critical. 

In its normative and standard-setting work, WHO is an evidence-based organisation with a focus on public health. Ongoing reviews of studies and evidence focused on integrated diagnostics has resulted in several recent guidelines and key recommendations. Adopting and adapting these recommendations will support improved access, services and care towards national and international disease elimination goals.

To drive innovation and disseminate information, key WHO activities can support national and international uptake, scale-up, and access of integrated diagnostic technologies. These include target product profiles, technology landscapes, and information on novel and innovative technologies, such as point-of-care technologies.

A target product profile (TPP) outlines the desired ‘profile’ or characteristics of a target product for a particular disease or condition. TPPs state intended use, target populations and other desired attributes of products, including safety and efficacy-related characteristics. Such profiles should guide funders and developers in product research and development as market indications of country needs.

Technology landscapes provide details and information of the variety of products available for a particular disease or condition. Though challenging to be completely exhaustive, these generally provide the availability and market considerations for a range of technologies. Technology landscapes have been created by WHO and/or partners. For integrated diagnostics, please see the detailed technology landscapes from Unitaid.

Innovations within testing and diagnostics progress rapidly. These novel and innovative technologies can support integrated diagnostics in an effort to provide optimized services and care to people living with HIV, hepatitis, STIs, and other diseases including tuberculosis and emerging infections.

Beyond sharing technologies, several key aspects in the diagnostic and laboratory system can be further integrated.

Specimen referral networks are currently significantly fragmented across diseases and within programmes. Several critical aspects of supply chain and procurement can be integrated across diseases, including forecasting (both for procurement and supplier negotiation), product selection, quantification, procurement, storage, transport and distribution. Especially for point-of-care and near point-of-care but also for laboratory-based technologies, data management systems and connectivity solutions should be compatible with national dashboards and databases and/or laboratory information management systems (LIMS) to create an integrated national system.

Finally, many different tools and checklists support quality assurance across diseases and test types; however, many components are similar and could be integrated. These include policies and policy development, site and user certification, proficiency testing panels, post-market surveillance, standardized registers and logbooks, new kit lot verification and training.