On May 29, 2013, Secretary Kathleen Sebelius, Department of Health and Human Services, determined there is a significant potential for a public health emergency involving the Middle East respiratory syndrome coronavirus (MERS-CoV) that has a significant potential to affect national security or the health and security of United States citizens living abroad. On the basis of the determination, she declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of the MERS-CoV.
On June 5, 2013, the Food and Drug Administration (FDA) Commissioner, Dr. Margaret A. Hamburg, authorized emergency use of the CDC Novel Coronavirus 2012 Real-Time RT-PCR Assay for the detection of MERS-CoV. Learn more.
The FDA also issued an Emergency Use Authorization (EUA) on June 5, 2013, to authorize use of CDC's 2012 real-time reverse transcription-PCR assay to test for MERS-CoV in clinical respiratory, serum, and stool specimens. CDC has distributed this assay to qualified laboratories in the United States and around the world. This EUA was expanded in June 2014 to allow use for testing asymptomatic contacts.
Conditions of Authorization
As specified in the June 5, 2013, Emergency Use Authorization (EUA)
- CDC will distribute the assay only to qualified laboratories.
- Questions regarding the designation of "qualified laboratories" within DOD can be referred to the appropriate point-of-contact via e-mail inquiry.
- Use of this kit is for diagnostic use only in accordance with the conditions of authorization as specified in the EUA and the assay's instructions for use as distributed with the assay.
- The CDC will collect information on the performance of the assay, and report to FDA any suspected occurrence of false positive or false negative results of which CDC becomes aware.
- Qualified laboratories will include with reports of the results the authorized Fact Sheet for Healthcare Providers and the authorized Fact Sheet for Patients.
- Fact sheets may be provided as electronic attachments to the test results, as a hard copy document, or via provision of an internet link to a web site that has posted the documents.
- Qualified laboratories will have a process in place for reporting test results to healthcare providers and federal, state, and/or local public health authorities, as appropriate.
- Laboratory management personnel shall coordinate with the installation's Public Health Emergency Officer regarding such reporting.
- Qualified laboratories will collect information on the performance of the assay, and report to CDC any suspected occurrence of false positive or false negative results of which they become aware.
- Qualified laboratories will ensure that any records associated with this EUA are maintained until notified by FDA. Such records will be made available to FDA for inspection upon request.
Note: This is not a complete listing of the Conditions – see the EUA for the full listing of conditions.
The CDC Novel Coronavirus 2012 Real-Time RT-PCR Assay is for use in patients with signs and symptoms of MERS-CoV in conjunction with clinical and epidemiological risk factors.
Screening Criteria
The Armed Forces Health Surveillance Division (AFHSD) recommends screening criteria for use within the DOD that differs slightly from that of the CDC. Due to frequent deployments with geographic exposure potential, questions surrounding transmission, and an unknown spectrum of illness presentation in DOD populations, AFHSD recommends screening criteria as follows:
| Category A |
Category B |
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A person with fever (≥ 38°C, 100.4°F) and symptoms of respiratory illness (not necessarily pneumonia; e.g., cough, shortness of breath);
AND EITHER
- a history of travel to the Arabian Peninsula or neighboring countries within 14 days before onset of illness;
OR
- close contact* with a symptomatic person who developed fever and respiratory illness within 14 days after traveling from the Arabian Peninsula or neighboring countries;
OR
- is a member of a cluster of patients with severe acute respiratory illness (e.g., fever and pneumonia requiring hospitalization) of unknown etiology in which MERS-CoV infection is being evaluated.
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Close contact* (or health care provider) of a confirmed or probable case of MERS-CoV infection while the case symptomatic. |
* Close contact is defined as a) being within approximately 6 ft (2 m), or within the room or care area, of a confirmed MERS case for a prolonged period of time (such as caring for, living with, visiting, or sharing a healthcare waiting area or room with, a confirmed MERS case) while not wearing recommended personal protective equipment or PPE (e.g., gowns, gloves, NIOSH-certified disposable N95 respirator, eye protection); or b) having direct contact with infectious secretions of a confirmed MERS case (e.g., being coughed on) while not wearing recommended personal protective equipment.