CDC guidelines on 2019 novel coronavirus for lab

Jan. 21, 2020

The Centers for Disease Control and Prevention (CDC) is closely monitoring an outbreak caused by a novel (new) coronavirus in Wuhan City, Hubei Province, China. Chinese authorities first identified the new coronavirus, which has resulted in about 200 confirmed human infections in China with three deaths reported. This is an emerging, rapidly evolving situation and CDC will provide updated information as it becomes available, in addition to updated guidance.

A number of countries, including the United States, are actively screening incoming travelers from Wuhan and exported cases have been confirmed in Thailand. Chinese health authorities posted the full genome of the so-called “2019 novel coronavirus” or “2019-nCoV” in GenBank, the NIH genetic sequence database, and in the Global Initiative on Sharing All Influenza Data (GISAID) portal.

Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals, including camels, cats and bats. Rarely, animal coronaviruses can evolve and infect people and then spread between people such as has been seen with MERS and SARS. Past MERS and SARS outbreaks have been complex, requiring comprehensive public health responses.

Many of the patients in the outbreak in Wuhan, China, have reportedly had some link to a large seafood and animal market, suggesting animal-to-person spread. However, a growing number of patients reportedly have not had exposure to animal markets, suggesting limited person-to-person spread is occurring.

Interim guidelines for collecting, handling, and testing clinical specimens from Patients Under Investigation (PUIs) for 2019 Novel Coronavirus (2019-nCoV):

Healthcare providers should contact their local/state health department immediately to notify them of patients with fever and lower respiratory illness who traveled to Wuhan, China, within 14 days of symptom onset. Local and state public health staff will determine if the patient meets the criteria for a patient under investigation (PUI) for 2019 Novel Coronavirus (2019-nCoV). Clinical specimens should be collected from PUIs for routine testing of respiratory pathogens at either clinical or public health labs. Note that clinical laboratories should NOT attempt viral isolation from specimens collected from 2019-nCoV PUIs.

At this time, diagnostic testing for 2019-nCoV can be conducted only at CDC.

State and local health departments who have identified a PUI should immediately notify CDC’s Emergency Operations Center (EOC) at 770-488-7100 to report the PUI and determine whether testing for 2019-NCoV at CDC is indicated. The EOC will assist local/state health departments to collect, store, and ship specimens appropriately to CDC, including during afterhours or on weekends/holidays.

Testing for other respiratory pathogens by the provider should be done as part of the initial evaluation and should not delay specimen shipping to CDC.

 If a PUI tests positive for another respiratory pathogen, after clinical evaluation and consultation with public health authorities, they may no longer be considered a PUI.

To increase the likelihood of detecting infection, CDC recommends:

Collection of three specimen types, lower respiratory, upper respiratory and serum specimens for testing is recommended. If possible, additional specimen types (e.g., stool, urine) should be collected and should be stored initially until decision is made by CDC whether additional specimen sources should be tested. Specimens should be collected as soon as possible once a PUI is identified regardless of symptom onset. Maintain proper infection control when collecting specimens.

Store specimens at 2-8°C and ship overnight to CDC on ice pack. Label each specimen container with the patient’s ID number (e.g., medical record number), unique specimen ID (e.g., laboratory requisition number), specimen type (e.g., serum) and the date the sample was collected. Complete a CDC Form 50.34 for each specimen submitted. In the upper left box of the form, 1) for test requested select “Respiratory virus molecular detection (non-influenza) CDC-10401” and 2) for at CDC, bring to the attention of enter “Stephen Lindstrom: 2019-nCoV PUI”.

Visit CDC for all the detailed laboratory specimen guidelines

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