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

Abstract

Diagnostics play a central role in the early detection and control of outbreaks and can enable a more nuanced understanding of the disease kinetics and risk factors for the Middle East respiratory syndrome-coronavirus (MERS-CoV), one of the high-priority pathogens identified by the WHO. In this review we identified sources for molecular and serological diagnostic tests used in MERS-CoV detection, case management and outbreak investigations, as well as surveillance for humans and animals (camels), and summarised the performance of currently available tests, diagnostic needs, and associated challenges for diagnostic test development and implementation. A more detailed understanding of the kinetics of infection of MERS-CoV is needed in order to optimise the use of existing assays. Notably, MERS-CoV point-of-care tests are needed in order to optimise supportive care and to minimise transmission risk. However, for new test development, sourcing clinical material continues to be a major challenge to achieving assay validation. Harmonisation and standardisation of laboratory methods are essential for surveillance and for a rapid and effective international response to emerging diseases. Routine external quality assessment, along with well-characterised and up-to-date proficiency panels, would provide insight into MERS-CoV diagnostic performance worldwide. A defined set of Target Product Profiles for diagnostic technologies will be developed by WHO to address these gaps in MERS-CoV outbreak management.

Middle East respiratory syndrome

“…77 An updated roadmap for MERS-CoV product development lists all available diagnostics and other diagnostics in the developmental phase. 84 Several diagnostic tests are under development to accelerate turnaround times from sample analysis to result. [85][86][87] A 2018 rapid and specific assay for the detection of MERS-CoV combines the reverse transcription loop-mediated isothermal amplification technique and a vertical flow visualisation strip (RT-LAMP-VF) to detect the nucleocapsid gene of MERS-CoV.…”

Drug-resistant tuberculosis in eastern Europe and central Asia: a time-series analysis of routine surveillance data

“…Importantly, despite many WHO MERS expert group and other stakeholder meetings that have defined priority research needs, major knowledge gaps remain in the epidemiology, transmission, pathogenesis, and phylogenetic evolution of MERS-CoV. 6,7 Major opportunities for appropriate longitudinal and cross-sectional studies to fill these gaps from the recurrent community and nosocomial outbreaks of MERS in Saudi Arabia are being missed. By contrast, several studies done after the 2015 MERS outbreak in South Korea yielded important epidemiological, clinical, virological, and management outcome data.…”

“…In South Africa, estimated tuberculosis incidence is declining by 0·5% annually, most likely driven by increased coverage of antiretroviral treatment for HIV. 7 By contrast, drug-resistant tuberculosis as a proportion of tuberculosis increased between two national surveys in 2001 and 2012, primarily driven by an increase in rifampicin mono-resistant tuberculosis. 8 Systematic reviews suggest an association between HIV and drug-resistant tuberculosis, with increased risks of drug-resistant tuberculosis in individuals who are tuberculosis treatment naive, suggesting a stronger association for transmitted resistance than acquired.…”

Confronting the persisting threat of the Middle East respiratory syndrome to global health security

“…3 2031 of these cases occurred in Saudi Arabia and the largest outbreak outside the Middle East occurred in South Korea in May, 2015, with 186 cases reported between May 15 and July 6, 2015, showing its epidemic potential. 6,7 Major opportunities for appropriate longitudinal and cross-sectional studies to fill these gaps from the recurrent community and nosocomial outbreaks of MERS in Saudi Arabia are being missed. 3 Worryingly, although MERS-CoV continues to circulate in the Middle East, progress in advancing priority research and development on the epidemiology, rapid diagnostics, treatments, and vaccines, including regional One Health activities 5 have been slow.…”

“…7 By contrast, drug-resistant tuberculosis as a proportion of tuberculosis increased between two national surveys in 2001 and 2012, primarily driven by an increase in rifampicin mono-resistant tuberculosis. In South Africa, estimated tuberculosis incidence is declining by 0·5% annually, most likely driven by increased coverage of antiretroviral treatment for HIV.…”