Strengthening primary healthcare through integrated diagnostics – Bridging gaps for better health outcomes

In healthcare, precision and timely diagnosis is the cornerstone of effective treatment. Integrating affordable, easy-to-use, point-of-care in vitro diagnostics (IVDs) in primary healthcare systems can substantially improve health outcomes, especially in low-resource settings.

For instance, innovations such as digital pulse oximeters, can help healthcare workers to identify and treat illnesses accurately and effectively. A smart stethoscope that can screen, detect, and predict cardiorespiratory disorders, can allow primary healthcare staff to carry out initial evaluation and share the digital files with specialists in hospitals for remote monitoring. Self-testing for conditions such as HIV can revolutionize how at-risk populations seek healthcare and avoid delays in treatment.

Despite their potential to shape public health outcomes, diagnostics have long been neglected. Estimates suggest that while diagnostics influence about 70 per cent of healthcare decisions, they account for only three to five per cent of healthcare spending. The WHO emphasizes that diagnosis is a critical enabler of universal health coverage but calls it the weakest link in the care cascade.

Given these challenges, what would it take to realize the vision of making affordable and quality diagnostics available to all, and strengthening this crucial link in healthcare systems?

One way forward is to develop and advance connected diagnostic systems that are rooted in local contexts and shaped by national health priorities. This can include electronic health record systems, laboratory surveillance networks, handheld diagnostic devices with internet connectivity, mobile-based health applications, and more.

Connected diagnostics offer many advantages including streamlining healthcare worker efforts, improving data accuracy and timeliness as well as access and security, and feeding into analytics and decision support systems for clinical care.

However, connected diagnostics strategies must consider factors such as the digital literacy and workloads of healthcare workers, patient’s trust, data privacy and storage. It must also contend with the realities of healthcare systems in low resource settings, which often lack basic infrastructure, connectivity, and interoperability.

There is a need to shift from single disease testing platforms to multi-disease diagnostic platforms. A one health approach is needed to ensure this shift, and the move to build a network of integrated laboratories at block, district, regional, and national levels under the Pradhan Mantri Ayushman Bharat Health Infrastructure Mission is a welcome step in this direction.

Diagnostics also have an important role to play in pandemic preparedness and surveillance, especially when combined with robust laboratory networks and surveillance systems, can help detect emerging pathogens and inform a pandemic response. Multiplex diagnostics kits, which allow for multiple biomarkers to be detected in a single test, will be a game changer in identification of one or multiple pathogens at the same point of time. This will help strengthening the diagnosis and surveillance and generate robust data.

There should also be a concerted effort to address demand side barriers as well as pathways to integrate diagnostics in a country’s health system. Both HIV and Covid-19 self-test kits are still not part of the public health programs in many low and middle-income countries.

Strengthening local manufacturers is another piece of the puzzle, since they are key stakeholders in improving self-reliance, in developing low cost and quality-assured tests and devices. In many regions, local manufacturers require support in market access and investment, implementing quality management systems and processes, navigating regulatory frameworks and guidelines, as well as technical assistance and capacity-building.

Creating an enabling R&D environment for the development and advancement of appropriate diagnostics is also a key factor in ensuring that diagnostics are successfully integrated, adopted and scaled up in primary healthcare settings.

Global initiatives such as the WHO’s Model List of Essential In Vitro Diagnostics and a groundbreaking resolution endorsed by the World Health Assembly in 2023 underscore the urgency of strengthening diagnostic capacity worldwide. To truly enhance public health outcomes, concerted efforts are needed to overcome barriers such as lack of supportive infrastructure and resources in low- and middle-income countries. By prioritizing diagnostics and supporting local manufacturers, we can pave the way for more effective and responsive primary healthcare systems that benefit communities worldwide.