Updated March 4, 2020

Limited information is available to characterize the spectrum of clinical illness associated with coronavirus disease 2019 (COVID-19). No vaccine or specific treatment for COVID-19 is available; care is supportive.

The CDC clinical criteria for a COVID-19 person under investigation (PUI) have been developed based on what is known about COVID-19 and are subject to change as additional information becomes available.

Criteria to Guide Evaluation of PUI for COVID-19

As availability of diagnostic testing for COVID-19 increases, clinicians will be able to access laboratory tests for diagnosing COVID-19 through clinical laboratories performing tests authorized by FDA under an Emergency Use Authorization (EUA). Clinicians will also be able to access laboratory testing through public health laboratories in their jurisdictions.

This expands testing to a wider group of symptomatic patients. Clinicians should use their judgment to determine if a patient has signs and symptoms compatible with COVID-19 and whether the patient should be tested. Decisions on which patients receive testing should be based on the local epidemiology of COVID-19, as well as the clinical course of illness. Most patients with confirmed COVID-19 have developed fever1 and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing). Clinicians are strongly encouraged to test for other causes of respiratory illness, including infections such as influenza.

Epidemiologic factors that may help guide decisions on whether to test include: any persons, including healthcare workers2, who have had close contact3 with a laboratory-confirmed4 COVID-19 patient within 14 days of symptom onset, or a history of travel from affected geographic areas5 (see below) within 14 days of symptom onset.

Recommendations for Reporting, Testing, and Specimen Collection

Updated February 28, 2020

Clinicians should immediately implement recommended infection prevention and control practices if a patient is suspected of having COVID-19. They should also notify infection control personnel at their healthcare facility and their state or local health department if a patient is classified as a PUI for COVID-19. State health departments that have identified a PUI or a laboratory-confirmed case should complete a PUI and Case Report form through the processes identified on CDC’s Coronavirus Disease 2019 website. State and local health departments can contact CDC’s Emergency Operations Center (EOC) at 770-488-7100 for assistance with obtaining, storing, and shipping appropriate specimens to CDC for testing, including after hours or on weekends or holidays.

For initial diagnostic testing for SARS-CoV-2, CDC recommends collecting and testing upper respiratory tract specimens (nasopharyngeal AND oropharyngeal swabs). CDC also recommends testing lower respiratory tract specimens, if available. For patients who develop a productive cough, sputum should be collected and tested for SARS-CoV-2. The induction of sputum is not recommended. For patients for whom it is clinically indicated (e.g., those receiving invasive mechanical ventilation), a lower respiratory tract aspirate or bronchoalveolar lavage sample should be collected and tested as a lower respiratory tract specimen. Specimens should be collected as soon as possible once a PUI is identified, regardless of the time of symptom onset. See Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Patients Under Investigation (PUIs) for COVID-19 and Biosafety FAQs for handling and processing specimens from suspected cases and PUIs.

Footnotes

1Fever may be subjective or confirmed

2For healthcare personnel, testing may be considered if there has been exposure to a person with suspected COVID-19 without laboratory confirmation. Because of their often extensive and close contact with vulnerable patients in healthcare settings, even mild signs and symptoms (e.g., sore throat) of COVID-19 should be evaluated among potentially exposed healthcare personnel. Additional information is available in CDC’s Interim U.S. Guidance for Risk Assessment and Public Health Management of Healthcare Personnel with Potential Exposure in a Healthcare Setting to Patients with Coronavirus Disease 2019 (COVID-19).

3Close contact is defined as—

4Documentation of laboratory-confirmation of COVID-19 may not be possible for travelers or persons caring for COVID-19 patients in other countries.

5Affected areas are defined as geographic regions where sustained community transmission has been identified. Relevant affected areas will be defined as a country with at least a CDC Level 2 Travel Health Notice. See all COVID-19 Travel Health Notices.

Additional Resources:

• State health department after-hours contact listexternal icon
• Directory of Local Health Departmentsexternal icon
• World Health Organization (WHO) Coronavirusexternal icon
• WHO guidance on clinical management of severe acute respiratory infection when COVID-19 is suspectedexternal icon
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