An updated roadmap for MERS-CoV research and product development: focus on diagnostics

Area of Science:

• Medical Diagnostics
• Infectious Disease Epidemiology
• Public Health

Background:

• Middle East respiratory syndrome-coronavirus (MERS-CoV) is a high-priority pathogen requiring effective diagnostic strategies.
• Diagnostics are vital for early outbreak detection, disease kinetics understanding, and risk factor identification.
• Current diagnostic approaches for MERS-CoV are reviewed to identify gaps and needs.

Purpose of the Study:

• To review molecular and serological diagnostic tests for MERS-CoV detection in humans and animals.
• To summarize test performance, diagnostic needs, and challenges in MERS-CoV test development and implementation.
• To inform the development of Target Product Profiles for MERS-CoV diagnostics.

Main Methods:

• Systematic review of diagnostic test sources for MERS-CoV.
• Analysis of test performance data for MERS-CoV detection.
• Identification of challenges in diagnostic test development, validation, and implementation.

Main Results:

• Various molecular and serological tests exist for MERS-CoV detection, case management, and surveillance.
• A need for improved understanding of MERS-CoV infection kinetics to optimize existing assays.
• Sourcing clinical materials remains a significant challenge for validating new MERS-CoV diagnostic tests.

Conclusions:

• Point-of-care MERS-CoV tests are needed to improve supportive care and reduce transmission.
• Harmonization and standardization of laboratory methods are essential for global surveillance and response.
• WHO will develop Target Product Profiles to address MERS-CoV diagnostic gaps.