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Interim Patient under Investigation (PUI) Guidance and Case Definitions

Patient Under Investigation (PUI)

A person who has both clinical features and an epidemiologic risk should be considered a patient under investigation (PUI) based on one of the following scenarios:

Clinical Features Epidemiologic Risk
Severe illness
Fever1 and pneumonia or acute respiratory distress syndrome (based on clinical or radiological evidence)
and A history of travel from countries in or near the Arabian Peninsula2 within 14 days before symptom onset, or close contact3 with a symptomatic traveler who developed fever1 and acute respiratory illness (not necessarily pneumonia) within 14 days after traveling from countries in or near the Arabian Peninsula2.

– or –

A member of a cluster of patients with severe acute respiratory illness (e.g., fever1 and pneumonia requiring hospitalization) of unknown etiology in which MERS-CoV is being evaluated, in consultation with state and local health departments in the US.

Milder illness
Fever1 and symptoms of respiratory illness (not necessarily pneumonia; e.g., cough, shortness of breath)
and A history of being in a healthcare facility (as a patient, worker, or visitor) within 14 days before symptom onset in a country or territory in or near the Arabian Peninsula2 in which recent healthcare-associated cases of MERS have been identified.
Fever1 or symptoms of respiratory illness (not necessarily pneumonia; e.g., cough, shortness of breath) and Close contact3 with a confirmed MERS case while the case was ill.

The above criteria serve as guidance for testing; however, patients should be evaluated and discussed with public health departments on a case-by-case basis if their clinical presentation or exposure history is equivocal (e.g., uncertain history of health care exposure).

 

Confirmed Case

A confirmed case is a person with laboratory confirmation of MERS-CoV infection. Confirmatory laboratory testing requires a positive PCR on at least two specific genomic targets or a single positive target with sequencing on a second.

 

Probable Case

A probable case is a PUI with absent or inconclusive laboratory results for MERS-CoV infection who is a close contact3 of a laboratory-confirmed MERS-CoV case. Examples of laboratory results that may be considered inconclusive include a positive test on a single PCR target, a positive test with an assay that has limited performance data available, or a negative test on an inadequate specimen.

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Footnotes

  1. Fever may not be present in some patients, such as those who are very young, elderly, immunosuppressed, or taking certain medications. Clinical judgement should be used to guide testing of patients in such situations.
  2. Countries considered in the Arabian Peninsula and neighboring include: Bahrain; Iraq; Iran; Israel, the West Bank, and Gaza; Jordan; Kuwait; Lebanon; Oman; Qatar; Saudi Arabia; Syria; the United Arab Emirates (UAE); and Yemen.
  3. Close contact is defined as a) being within approximately 6 feet (2 meters), 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. See CDC’s Interim Infection Prevention and Control Recommendations for Hospitalized Patients with MERS. Data to inform the definition of close contact are limited; considerations when assessing close contact include the duration of exposure (e.g., longer exposure time likely increases exposure risk) and the clinical symptoms of the person with MERS (e.g., coughing likely increases exposure risk). Special consideration should be given to those exposed in healthcare settings. For detailed information regarding healthcare personnel (HCP) please review CDC Interim U.S. Guidance for Monitoring and Movement of Persons with Potential Middle East Respiratory Syndrome (MERS-CoV) Exposure. Transient interactions, such as walking by a person with MERS, are not thought to constitute an exposure; however, final determination should be made in consultation with public health authorities.

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