Advances in addressing technical challenges of point-of-care diagnostics in resource-limited settings

ABSTRACT

The striking prevalence of HIV, TB and malaria, as well as outbreaks of emerging infectious diseases, such as influenza A (H7N9), Ebola and MERS, poses great challenges for patient care in resource-limited settings (RLS). However, advanced diagnostic technologies cannot be implemented in RLS largely due to economic constraints. Simple and inexpensive point-of-care (POC) diagnostics, which rely less on environmental context and operator training, have thus been extensively studied to achieve early diagnosis and treatment monitoring in non-laboratory settings. Despite great input from material science, biomedical engineering and nanotechnology for developing POC diagnostics, significant technical challenges are yet to be overcome. Summarized here are the technical challenges associated with POC diagnostics from a RLS perspective and the latest advances in addressing these challenges are reviewed.

KEYWORDS:

• Technical challenges
• point-of-care
• diagnostics
• infectious diseases
• resource-limited settings

Financial & competing interests disclosure

U Demirci is a founder of, and has an equity interest in: (i) DxNow Inc., a company that is developing microfluidic and imaging technologies for point-of-care diagnostic solutions, and (ii) Koek Biotech, a company that is developing microfluidic IVF technologies for clinical solutions. U Demirci’s interests were viewed and managed in accordance with the conflict of interest policies. U Demirci acknowledges the support of NIH R01 DE02497101, U54EB015408, R01 GM108584 and the Epilepsy Foundation Shark Tank Prize.

S Wang acknowledges the support of the Fundamental Research Funds for the Central Universities (2015QNA7026) from China.

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Key issues

• The technical challenges of POC diagnostics need to be divided and defined according to the specific requirements for clinical needs and operation conditions so that they can be addressed in the right context.

• Low sensitivity and limited multiplexing capability of protein-based POC diagnostic technologies should be improved to accommodate clinical needs in RLS under the WHO ASSURED guidelines.

• Sample-to-answer capability should be achieved for nucleic acid- and cell-based POC assays with the aid of inexpensive, portable and battery-operated instrument to streamline their translation to RLS.

• Joint efforts from interdisciplinary research from material science, biomedical engineering and computer science, as well as collaboration with industry are urgently needed to synergistically speed up the development of POC diagnostics.

• Cell phone should be increasingly integrated with POC diagnostics during assay development for data collection, analysis, reporting and documentation because of its widespread use in RLS.