Development of Medical Countermeasures to Middle East Respiratory Syndrome Coronavirus

Timothy M. Uyeki; Karl J. Erlandson; George Korch; Michael O'Hara; Michael Wathen; Jean Hu-Primmer; Sally Hojvat; Erik J. Stemmy; Armen Donabedian


Emerging Infectious Diseases. 2016;22(7):e1-e11. 

In This Article

Diagnostic Devices

Critical issues for facilitating appropriate clinical management of MERS-CoV cases and for implementing infection prevention and control measures in healthcare facilities is the prompt diagnosis of MERS-CoV infection and the monitoring of prolonged viral shedding in severely ill patients and their healthcare and family contacts. Outside of the United States, several commercial and in-house academic laboratory reverse transcription PCR (RT-PCR) molecular assays are available for research, diagnostic, and viral load monitoring purposes. These assays can measure MERS-CoV RNA in samples from symptomatic patients and their asymptomatic contacts. Contributing factors to recent large clusters of MERS-CoV infection in hospitals in Saudi Arabia and South Korea may be linked to inadequate infection-control procedures and prolonged shedding of MERS-CoV. MERS-CoV RNA has been detected for 24–31 days after onset of fever in hospitalized patients.[29,30]

The Secretary of the US Department of Health and Human Services declared a potential public health emergency on May 29, 2013, regarding MERS-CoV infection that could have a high potential to affect national security or the health and security of US citizens living abroad. The US Food and Drug Administration (FDA) subsequently issued an emergency use authorization to the Centers for Diseases Control and Prevention (CDC) for an in vitro molecular diagnostic test to diagnose MERS-CoV infection in multiple types of clinical specimens from symptomatic patients. The use of this test was later expanded to include the ability to test asymptomatic contacts of a person infected with MERS-CoV who traveled from Saudi Arabia to the United States. The CDC made this test available to multiple US public health laboratories, the US Department of Defense, and WHO laboratories worldwide. Although the test has been distributed extensively, it is limited in terms of the CDC's ability to scale up the supply of reagents to support a surge in MERS-CoV cases in the United States and in other countries where the test has been made available. Therefore, an emergency use authorization was issued on July 17, 2015, for the commercially developed RealStar MERS-CoV RT-PCR Kit U.S. (Altona Diagnostics GmbH, Hamburg, Germany) for use in the in vitro qualitative detection of MERS-CoV RNA in tracheal aspirate or tracheal secretion samples.[31] Although this commercial assay is a first step in bridging the diagnostic test availability gap in case of a surge scenario, the current coverage, at least in the United States, is insufficient until alternative, FDA-cleared commercial tests are available (Table 2).

A worldwide gap exists in the lack of readily available, simple, rapid, and accurate diagnostic tests for use in outpatient and inpatient clinical settings where the ability of the facility to use currently available, higher complexity molecular tests is limited. The lack of commercial development of MERS-CoV assays may be partially related to the limited availability of clinical specimens and MERS-CoV isolates from infected patients. Availability of serum specimens from RT-PCR–confirmed MERS-CoV patients who survived can help facilitate development of serologic tests. If paired acute and convalescent serum samples are available, serologic tests can be used to confirm MERS-CoV infection when viral shedding is not detectable, and for surveillance purposes such as measuring population exposures and immunity to MERS-CoV infection.