COVID-19 Point-of-Care Diagnostics That Satisfy Global Target Product Profiles.

Area of Science:

• Public Health
• Infectious Diseases
• Diagnostic Technologies

Background:

• The COVID-19 pandemic necessitates strategies beyond vaccination for public health and economic recovery.
• Strict lockdowns are unsustainable; rapid diagnostic testing offers a viable alternative for societal reopening.
• Variability in available point-of-care tests (POCTs) complicates selection for specific use cases.

Purpose of the Study:

• To evaluate COVID-19 point-of-care diagnostic tests (POCTs) against World Health Organization (WHO) target product profiles (TPPs).
• To identify high-performing POCTs suitable for large-scale deployment in managing the COVID-19 pandemic.

Main Methods:

• Systematic screening of available POCTs based on WHO TPPs for COVID-19 diagnostics.
• Evaluation criteria included clinical sensitivity, specificity, limit of detection, and time to results.
• Focus on tests for direct detection of SARS-CoV-2 (acute infection) and indirect detection of host antibodies (past infection).

Main Results:

• Several POCTs were identified that meet WHO TPP criteria for SARS-CoV-2 detection.
• Highlighted tests demonstrate strong performance in sensitivity, specificity, and rapid turnaround times.
• Selected POCTs are suitable for both acute and past infection diagnosis.

Conclusions:

• Well-performing POCTs can be a critical tool for managing COVID-19 transmission.
• Adherence to WHO TPPs ensures the selection of reliable and effective diagnostic solutions.
• Strategic deployment of POCTs can support the safe reopening of societies and economies.