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CDC 2019-nCoV Case Definition and Guidance Update


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Update and Interim Guidance on Outbreak of 2019 Novel Coronavirus (2019-nCoV) in Wuhan, China

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HAN Health Update

 

Distributed via the CDC Health Alert Network
January 17, 2020, 2030 ET (8:30 PM ET)
CDCHAN-00426

Summary
The Centers for Disease Control and Prevention (CDC) continues to closely monitor an outbreak of a 2019 novel coronavirus (2019-nCoV) in Wuhan City, Hubei Province, China that began in December 2019. CDC has established an Incident Management System to coordinate a domestic and international public health response.

Coronaviruses are a large family of viruses. Some cause illness in people; numerous other coronaviruses 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 Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV) (https://www.cdc.gov/coronavirus/mers/index.html) and Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) (https://www.cdc.gov/sars/index.html).

Chinese authorities report most patients in the Wuhan City outbreak have been epidemiologically linked to a large seafood and animal market, suggesting a possible zoonotic origin to the outbreak. Chinese authorities additionally report that they are monitoring several hundred healthcare workers who are caring for outbreak patients; no spread of this virus from patients to healthcare personnel has been reported to date. Chinese authorities are reporting no ongoing spread of this virus in the community, but they cannot rule out that some limited person-to-person spread may be occurring. China has reported that two of the patients have died, including one with pre-existing medical conditions. Chinese health officials publicly posted the genetic sequence of the 2019-nCoV on January 12, 2020. This will facilitate identification of infections with this virus and development of specific diagnostic tests.

Thailand and Japan have confirmed additional cases of 2019-nCoV in travelers from Wuhan, China. It is possible that more cases will be identified in the coming days. This is an ongoing investigation and given previous experience with MERS-CoV and SARS-CoV, it is possible that person-person spread may occur. There is much more to learn about the transmissibility, severity, and other features associated with 2019-nCoV as the investigations in China, Thailand, and Japan continue. Additional information about this novel virus is needed to better inform population risk.

This HAN Update provides a situational update and guidance to state and local health departments and healthcare providers that supersedes guidance in CDC’s HAN Advisory 424 distributed on January 8, 2020. This HAN Update adds guidance for evaluation of patients under investigation (PUI) for 2019-nCoV, prevention and infection control guidance, including the addition of an eye protection recommendation, and additional information on specimen collection.

Background
An outbreak of pneumonia of unknown etiology in Wuhan City was initially reported to WHO on December 31, 2019. Chinese health authorities have confirmed more than 40 infections with a novel coronavirus as the cause of the outbreak. Reportedly, most patients had epidemiological links to a large seafood and animal market. The market was closed on January 1, 2020. Currently, Chinese health authorities report no community spread of this virus, and no transmission among healthcare personnel caring for outbreak patients. No additional cases of infection with 2019-nCoV have been identified in China since January 3, 2020.

On January 13, 2020 public health officials in Thailand confirmed detection of a human infection with 2019-nCoV in a traveler from Wuhan, China. This was the first confirmed case of 2019-nCoV documented outside China. On January 17, 2020 a second case was confirmed in Thailand, also in a returned traveler from Wuhan City. On January 15, 2020 health officials in Japan confirmed 2019-nCoV infection in a returned traveler from Wuhan City. These persons had onset dates after January 3, 2020. These cases did not report visiting the large seafood and animal market to which many cases in China have been linked.

On January 11, 2020, CDC updated the level 1 travel health notice (“practice usual precautions”) for Wuhan City, Hubei Province, China with additional information (originally issued on January 6, 2020): https://wwwnc.cdc.gov/travel/notices/watch/novel-coronavirus-china.

Recommendations for Healthcare Providers
Limited information is available to characterize the spectrum of clinical illness associated with 2019-nCoV. No vaccine or specific treatment for 2019-nCoV infection is available; care is supportive.

The CDC clinical criteria for a 2019-nCoV patient under investigation (PUI) have been developed based on what is known about MERS-CoV and SARS-CoV and are subject to change as additional information becomes available.

Healthcare providers should obtain a detailed travel history for patients being evaluated with fever and acute respiratory illness. CDC guidance for evaluating and reporting a PUI for MERS-CoV remains unchanged.

Criteria to Guide Evaluation of Patients Under Investigation (PUI) for 2019-nCoV
Patients in the United States who meet the following criteria should be evaluated as a PUI in association with the outbreak of 2019-nCoV in Wuhan City, China.

1) Fever1 AND symptoms of lower respiratory illness (e.g., cough, shortness of breath)
–and in the last 14 days before symptom onset,

  • History of travel from Wuhan City, China
    -or-
  • Close contact2 with a person who is under investigation for 2019-nCOV while that person was ill.

2) Fever1 OR symptoms of lower respiratory illness (e.g., cough, shortness of breath)
–and in the last 14 days before symptom onset,

  • Close contact2 with an ill laboratory-confirmed 2019-nCoV patient.

The above criteria are also available at https://www.cdc.gov/coronavirus/2019-nCoV/clinical-criteria.html. The criteria are intended to serve as guidance for evaluation. 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 travel or exposure).

Recommendations for Reporting, Testing, and Specimen Collection
Healthcare providers should immediately notify both infection control personnel at their healthcare facility and their local or state health department in the event of a PUI for 2019-nCoV. State health departments that have identified a PUI should immediately contact CDC’s Emergency Operations Center (EOC) at 770-488-7100 and complete a 2019-nCoV PUI case investigation form available at https://www.cdc.gov/coronavirus/2019-ncov/downloads/pui-form.pdfpdf icon. CDC’s EOC will assist local/state health departments to collect, store, and ship specimens appropriately to CDC, including during afterhours or on weekends/holidays. At this time, diagnostic testing for 2019-nCoV can be conducted only at CDC. Testing for other respiratory pathogens 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. This may evolve as more information becomes available on possible 2019 nCoV co-infections.

For biosafety reasons, it is not recommended to perform virus isolation in cell culture or initial characterization of viral agents recovered in cultures of specimens from a PUI for 2019-nCoV. To increase the likelihood of detecting 2019-nCoV infection, CDC recommends collecting and testing multiple clinical specimens from different sites, including all three specimen types—lower respiratory, upper respiratory, and serum specimens. Additional specimen types (e.g., stool, urine) may be collected and stored. Specimens should be collected as soon as possible once a PUI is identified regardless of time of symptom onset. Additional guidance for collection, handling, and testing of clinical specimens is available at https://www.cdc.gov/coronavirus/2019-nCoV/.

Interim Healthcare Infection Prevention and Control Recommendations for Patients Under Investigation for 2019-nCoV
Although the transmission dynamics have yet to be determined, CDC currently recommends a cautious approach to patients under investigation for 2019-nCoV (https://www.cdc.gov/coronavirus/2019-nCoV/clinical-criteria.html). Such patients should be asked to wear a surgical mask as soon as they are identified and be evaluated in a private room with the door closed, ideally an airborne infection isolation room if available. Healthcare personnel entering the room should use standard precautions, contact precautions, airborne precautions, and use eye protection (e.g., goggles or a face shield). Immediately notify your healthcare facility’s infection control personnel and local health department.

Additional Infection Control Practices Resources

Notes
1Fever may not be present in some patients, such as those who are very young, elderly, immunosuppressed, or taking certain fever-lowering medications. Clinical judgment should be used to guide testing of patients in such situations.
2Close contact with a person who is under investigation for 2019-nCOV.
Close contact is defined as—

a) being within approximately 6 feet (2 meters), or within the room or care area, of a novel coronavirus case for a prolonged period of time while not wearing recommended personal protective equipment or PPE (e.g., gowns, gloves, NIOSH-certified disposable N95 respirator, eye protection); close contact can include caring for, living with, visiting, or sharing a healthcare waiting area or room with a novel coronavirus case.
– or –
b) having direct contact with infectious secretions of a novel coronavirus case (e.g., being coughed on) while not wearing recommended personal protective equipment.

See CDC’s Interim Healthcare Infection Prevention and Control Recommendations for Patients Under Investigation for 2019 Novel Coronavirus (https://www.cdc.gov/coronavirus/2019-nCoV/infection-control.html).

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 novel coronavirus (e.g., coughing likely increases exposure risk as does exposure to a severely ill patient). Special consideration should be given to those exposed in healthcare settings.

For More Information
More information is available at at https://www.cdc.gov/coronavirus/2019-nCoV/index.html or by calling 800-CDC-INFO | (800-232-4636) | TTY: (888) 232-6348

 

The Centers for Disease Control and Prevention (CDC) protects people’s health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national and international organizations.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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  • Health Alert: Conveys the highest level of importance; warrants immediate action or attention.
  • Health Advisory: Provides important information for a specific incident or situation; may not require immediate action.
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This message was distributed to state and local health officers, state and local epidemiologists, state and local laboratory directors, public information officers, HAN coordinators, and clinician organizations.
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https://emergency.cdc.gov/han/han00426.asp
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2019 Novel Coronavirus (2019-nCoV), Wuhan, China

This is an emerging, rapidly evolving situation and CDC will provide updated information as it becomes available, in addition to updated guidance.

 

Updated January 17, 2020

Situation Summary

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 identified the new coronavirus, which has resulted in more than 40 confirmed human infections in China with two deaths reportedexternal icon. A number of countries are actively screening incoming travelers from Wuhan and exported cases have been confirmed in Thailandexternal icon and Japanexternal icon.

Chinese health authorities posted the full genome of the so-called “2019 novel coronavirus” or “2019-nCoV” in GenBankexternal icon, the NIH genetic sequence database, and in the Global Initiative on Sharing All Influenza Data (GISAIDexternal icon) 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.

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. Some patients in the outbreak reportedly have not had exposure to animal markets, suggesting that some limited person-to-person spread is occurring.

There are ongoing investigations to learn more. This is a rapidly evolving situation and information will be updated as it becomes available.

Risk Assessment

Outbreaks of novel virus infections among people are always of public health concern. The risk from these outbreaks depends on characteristics of the virus, including whether and how well it spreads between people, the severity of resulting illness, and the medical or other measures available to control the impact of the virus (for example, vaccine or treatment medications).

Chinese health authoritiesexternal icon have reported that many patients in China visited a large seafood and animal market. They additionally report that several hundred health care workers caring for outbreak patients are being monitored and no spread of this virus from patients to health care workers has been detected. They report no sustained spread of this virus in the community, but there are indications that some limited person-to-person spread may have occurred. Cases outside China have all occurred in travelers from Wuhan.

There is much more to learn about how the 2019-nCoV virus spreads, severity of associated illness, and other features of the virus. Investigations are ongoing. Based on current information, however, the immediate health risk from 2019-nCoV to the general American public is deemed to be low at this time. Nevertheless, CDC is taking proactive preparedness precautions.

What to Expect

Access to the full genetic sequence of 2019-nCoV will help identify infections with this virus going forward. More cases may be identified in the coming days, including more in countries outside China, and possibly in the United States. Given what has occurred previously with MERS and SARS, it’s likely that some limited person-to-person spread will continue to occur.

CDC Response

  • CDC is closely monitoring this situation and is working with WHO.
  • CDC has established an Incident Management Structure to optimize domestic and international coordination to this emerging public health threat.
  • CDC has updated its interim travel health notice for this destination to provide information to people who may be traveling to Wuhan City and who may get sick.
  • CDC laboratories currently have the capacity to detect 2019-nCoV by sequencing the virus and comparing the sequences against the genetic sequence that are publicly posted. CDC also is using the genetic sequence data provided by China to begin work on a test to detect this virus more easily. Currently, testing for this virus must take place at CDC.
  • On January 17, CDC will begin entry screening of passengers on direct and connecting flights from Wuhan China to the three main ports of entry in the United States.
  • On January 17, CDC issued an updated interim Health Alert Notice (HAN) Advisory to inform state and local health departments and health care providers about this outbreak.

Other Available Resources

The following resources are available with information on 2019-nCoV

https://www.cdc.gov/coronavirus/2019-nCoV/summary.html

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Interim Guidance for Implementing Home Care of People Not Requiring Hospitalization for 2019 Novel Coronavirus (2019-nCoV)

This interim guidance is for staff at local and state health departments, infection prevention and control professionals, healthcare providers, and healthcare workers who are coordinating the home care and isolation1 of people who are confirmed to have, or being evaluated for 2019 novel coronavirus (2019-nCoV) infection (see Criteria to Guide Evaluation of Patients Under Investigation (PUI) for 2019-nCoV). This document does not apply to patients in healthcare settings. For interim healthcare infection prevention and control recommendations, see (insert link). Although the potential for human-to-human transmission of 2019-nCoV is unknown, this interim guidance is based on what is currently known about transmission of other viral respiratory infections. CDC will update this interim guidance as needed and as more information becomes available.

People who are confirmed to have, or being evaluated for, 2019-nCoV infection and do not require hospitalization for medical reasons may be cared for in a residential setting after a healthcare professional determines that the setting is suitable. Providers should contact their state or local health department to discuss home care, home isolation, or other measures for close contacts and for patients under investigation (PUI) for 2019-nCoV, and to discuss criteria for discontinuing any such measures. See Interim Guidance for Health Professionals for more information.

Assess the Suitability of the Residential Setting for Home Care

In consultation with state or local health department staff, a healthcare professional should

  • assess whether the residential setting is suitable and appropriate for home care;
  • assess whether the patient is capable of adhering to precautions that will be recommended as part of home care or isolation (respiratory hygiene, hand hygiene, etc.); and
  • notify their local or state health department that the residential setting has been determined to be suitable for home care and that hospital discharge is planned.

Provide Guidance for Precautions to Implement during Home Care

A healthcare professional should

 
Page last reviewed: January 18, 2020

https://www.cdc.gov/coronavirus/2019-ncov/guidance-home-care.html

 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Interim Guidance for Preventing 2019 Novel Coronavirus (2019-nCoV) from Spreading to Others in Homes and Communities

This interim guidance is based on what is currently known about 2019 novel coronavirus (2019-nCoV) and transmission of other viral respiratory infections. CDC will update this interim guidance as needed and as additional information becomes available.

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. The potential for human-to-human transmission of 2019-nCoV is unknown. The following interim guidance may help prevent this virus from spreading among people in homes and in communities.

This interim guidance is for:

  • people confirmed to have 2019-nCoV infection, who do not need to be hospitalized and who can receive care at home
  • people being evaluated by a healthcare provider for 2019-nCoV infection, who do not need to be hospitalized and who can receive care at home
  • caregivers and household members of a person confirmed to have, or being evaluated for, 2019-nCoV infection
  • other people who have had close contact with a person confirmed to have, or being evaluated for, 2019-nCoV infection

Prevention Steps for People who may have 2019-nCoV Infection

If you are feeling sick and are confirmed to have, or being evaluated for, 2019-nCoV infection you should follow the prevention steps below until a healthcare provider or local or state health department says you can return to your normal activities.

Stay home except to get medical care

You should restrict activities outside your home, except for getting medical care. Do not go to work, school, or public areas, and do not use public transportation or taxis.

Separate yourself from other people in your home

As much as possible, you should stay in a different room from other people in your home. Also, you should use a separate bathroom, if available.

Call ahead before visiting your doctor

Before your medical appointment, call the healthcare provider and tell them that you have, or are being evaluated for, 2019-nCoV infection. This will help the healthcare provider’s office take steps to keep other people from getting infected.

Wear a facemask

You should wear a facemask when you are in the same room with other people and when you visit a healthcare provider. If you cannot wear a facemask, the people who live with you should wear one while they are in the same room with you.

Cover your coughs and sneezes

Cover your mouth and nose with a tissue when you cough or sneeze, or you can cough or sneeze into your sleeve. Throw used tissues in a lined trash can, and immediately wash your hands with soap and water for at least 20 seconds.

Wash your hands

Wash your hands often and thoroughly with soap and water for at least 20 seconds. You can use an alcohol-based hand sanitizer if soap and water are not available and if your hands are not visibly dirty. Avoid touching your eyes, nose, and mouth with unwashed hands.

Avoid sharing household items

You should not share dishes, drinking glasses, cups, eating utensils, towels, bedding, or other items with other people in your home. After using these items, you should wash them thoroughly with soap and water.

Monitor your symptoms

Seek prompt medical attention if your illness is worsening (e.g., difficulty breathing). Before going to your medical appointment, call the healthcare provider and tell them that you have, or are being evaluated for, 2019-nCoV infection. This will help the healthcare provider’s office take steps to keep other people from getting infected. Ask your healthcare provider to call the local or state health department.

Prevention Steps for Caregivers and Household Members

If you live with, or provide care at home for, a person confirmed to have, or being evaluated for, 2019-nCoV infection, you should:

  • Make sure that you understand and can help the person follow the healthcare provider’s instructions for medication and care. You should help the person with basic needs in the home and provide support for getting groceries, prescriptions, and other personal needs.
  • Have only people in the home who are essential for providing care for the person.
    • Other household members should stay in another home or place of residence. If this is not possible, they should stay in another room, or be separated from the person as much as possible. Use a separate bathroom, if available.
    • Restrict visitors who do not have an essential need to be in the home.
    • Keep elderly people and those who have compromised immune systems or chronic health conditions away from the person. This includes people with chronic heart, lung or kidney conditions, and diabetes.
  • Make sure that shared spaces in the home have good air flow, such as by an air conditioner or an opened window, weather permitting.
  • Wash your hands often and thoroughly with soap and water for at least 20 seconds. You can use an alcohol-based hand sanitizer if soap and water are not available and if your hands are not visibly dirty. Avoid touching your eyes, nose, and mouth with unwashed hands.
  • Wear a disposable facemask, gown, and gloves when you touch or have contact with the person’s blood, body fluids and/or secretions, such as sweat, saliva, sputum, nasal mucus, vomit, urine, or diarrhea.
    • Throw out disposable facemasks, gowns, and gloves after using them. Do not reuse.
    • Wash your hands immediately after removing your facemask, gown, and gloves.
  • Avoid sharing household items. You should not share dishes, drinking glasses, cups, eating utensils, towels, bedding, or other items with a person who is confirmed to have, or being evaluated for, 2019-nCoV infection. After the person uses these items, you should wash them thoroughly (see below “Wash laundry thoroughly”).
  • Clean all “high-touch” surfaces, such as counters, tabletops, doorknobs, bathroom fixtures, toilets, phones, keyboards, tablets, and bedside tables, every day. Also, clean any surfaces that may have blood, body fluids and/or secretions or excretions on them.
    • Read label of cleaning products and follow recommendations provided on product labels. Labels contain instructions for safe and effective use of the cleaning product including precautions you should take when applying the product, such as wearing gloves or aprons and making sure you have good ventilation during use of the product.
    • Use a diluted bleach solution or a household disinfectant with a label that says “EPA-approved.” To make a bleach solution at home, add 1 tablespoon of bleach to 1 quart (4 cups) of water. For a larger supply, add ¼ cup of bleach to 1 gallon (16 cups) of water.
  • Wash laundry thoroughly.
    • Immediately remove and wash clothes or bedding that have blood, body fluids and/or secretions or excretions on them.
    • Wear disposable gloves while handling soiled items. Wash your hands immediately after removing your gloves.
    • Read and follow directions on labels of laundry or clothing items and detergent. In general, wash and dry with the warmest temperatures recommended on the clothing label.
  • Place all used disposable gloves, gowns, facemasks, and other contaminated items in a lined container before disposing them with other household waste. Wash your hands immediately after handling these items.
  • Monitor the person’s symptoms. If they are getting sicker, call his or her medical provider and tell them that the person has, or is being evaluated for, 2019-nCoV infection. This will help the healthcare provider’s office take steps to keep other people from getting infected. Ask the healthcare provider to call the local or state health department.
  • Caregivers and household members who do not follow precautions when in close contact with a person who is confirmed to have, or being evaluated for, 2019-nCoV infection, are considered “close contacts” and should monitor their health. Follow the prevention steps for close contacts below.
  • Discuss any additional questions with you state or local health department

Prevention Steps for Close Contacts

If you have had close contact with someone who is confirmed to have, or being evaluated for, 2019-nCoV infection, you should:

  • Monitor your health starting from the day you first had close contact with the person and continue for 14 days after you last had close contact with the person. Watch for these signs and symptoms:
    • Fever. Take your temperature twice a day.
    • Coughing.
    • Shortness of breath or difficulty breathing.
    • Other early symptoms to watch for are chills, body aches, sore throat, headache, diarrhea, nausea/vomiting, and runny nose.
  • If you develop any of these symptoms, follow the prevention steps for caregivers and household members described above, and call your healthcare provider as soon as possible. Before going to your medical appointment, call the healthcare provider and tell them about your close contact with someone who is confirmed to have, or being evaluated for, 2019-nCoV infection. This will help the healthcare provider’s office take steps to keep other people from getting infected. Ask your healthcare provider to call the local or state health department.
  • If you do not have any symptoms, you can continue with your daily activities, such as going to work, school, or other public areas.
 
Page last reviewed: January 18, 2020

https://www.cdc.gov/coronavirus/2019-ncov/guidance-prevent-spread.html

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Interim Guidance for Healthcare Professionals

Limited information is available to characterize the spectrum of clinical illness associated with 2019-nCoV. No vaccine or specific treatment for 2019-nCoV infection is available; care is supportive.

The CDC clinical criteria for a 2019-nCoV patient under investigation (PUI) have been developed based on what is known about MERS-CoV and SARS-CoV and are subject to change as additional information becomes available.

Health care providers should obtain a detailed travel history for patients being evaluated with fever and acute respiratory illness. CDC guidance for evaluating and reporting a PUI for MERS-CoV remains unchanged.

Criteria to Guide Evaluation of Patients Under Investigation (PUI) for 2019-nCoV

Patients in the United States who meet the following criteria should be evaluated as a PUI in association with the outbreak of 2019-nCoV in Wuhan City, China.

phone iconContact your local or state health departmentexternal icon

Healthcare providers should immediately notify their local or state health department in the event of a PUI for 2019-nCoV.

Clinical features and epidemiologic risk
Clinical Features & Epidemiologic Risk
Fever1 and symptoms of lower respiratory illness (e.g., cough, difficulty breathing) and In the last 14 days before symptom onset, a history of travel from Wuhan City, China.

– or –

In the last 14 days before symptom onset, close contact2 with a person who is under investigation for 2019-nCoV while that person was ill.

Fever1 or symptoms of lower respiratory illness (e.g., cough, difficulty breathing) and In the last 14 days, close contact2 with an ill laboratory-confirmed 2019-nCoV patient.

The criteria are intended to serve as guidance for evaluation. 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 travel or exposure).

Recommendations for Reporting, Testing, and Specimen Collection

Updated January 17, 2020

Healthcare providers should immediately notify both infection control personnel at their healthcare facility and their local or state health department in the event of a PUI for 2019-nCoV. State health departments that have identified a PUI should immediately contact CDC’s Emergency Operations Center (EOC) at 770-488-7100 and complete a 2019-nCoV PUI case investigation form available below.

CDC’s EOC will assist local/state health departments to collect, store, and ship specimens appropriately to CDC, including during afterhours or on weekends/holidays. At this time, diagnostic testing for 2019-nCoV can be conducted only at CDC.

Testing for other respiratory pathogens 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. This may evolve as more information becomes available on possible 2019-nCoV co-infections.

For biosafety reasons, it is not recommended to perform virus isolation in cell culture or initial characterization of viral agents recovered in cultures of specimens from a PUI for 2019-nCoV.

To increase the likelihood of detecting 2019-nCoV infection, CDC recommends collecting and testing multiple clinical specimens from different sites, including all three specimen types—lower respiratory, upper respiratory, and serum specimens. Additional specimen types (e.g., stool, urine) may be collected and stored. Specimens should be collected as soon as possible once a PUI is identified regardless of time of symptom onset. Additional guidance for collection, handling, and testing of clinical specimens is available.

Interim Healthcare Infection Prevention and Control Recommendations for Patients Under Investigation for 2019-nCoV

Footnotes

1Fever may not be present in some patients, such as those who are very young, elderly, immunosuppressed, or taking certain fever-lowering medications. Clinical judgment should be used to guide testing of patients in such situations.

2Close contact is defined as—

a) being within approximately 6 feet (2 meters), or within the room or care area, of a novel coronavirus case for a prolonged period of time while not wearing recommended personal protective equipment or PPE (e.g., gowns, gloves, NIOSH-certified disposable N95 respirator, eye protection); close contact can include caring for, living with, visiting, or sharing a health care waiting area or room with a novel coronavirus case.– or –

b) having direct contact with infectious secretions of a novel coronavirus case (e.g., being coughed on) while not wearing recommended personal protective equipment.

See CDC’s Interim Healthcare Infection Prevention and Control Recommendations for Patients Under Investigation for 2019 Novel Coronavirus

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 novel coronavirus (e.g., coughing likely increases exposure risk as does exposure to a severely ill patient). Special consideration should be given to those exposed in health care settings.

Additional Resources:

 
Page last reviewed: January 17, 2020

https://www.cdc.gov/coronavirus/2019-nCoV/clinical-criteria.html

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Interim Healthcare Infection Prevention and Control Recommendations for Patients Under Investigation for 2019 Novel Coronavirus

Although the transmission dynamics have yet to be determined, CDC currently recommends a cautious approach to patients under investigation for 2019 Novel Coronavirus Such patients should be asked to wear a surgical mask as soon as they are identified and be evaluated in a private room with the door closed, ideally an airborne infection isolation room if available. Healthcare personnel entering the room should use standard precautions, contact precautions, airborne precautions, and use eye protection (e.g., goggles or a face shield). Immediately notify your healthcare facility’s infection control personnel and local health department.

Additional Infection Control Practices Resources

 
Page last reviewed: January 15, 2020

https://www.cdc.gov/coronavirus/2019-nCoV/infection-control.html

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Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Patients Under Investigation (PUIs) for 2019 Novel Coronavirus (2019-nCoV)

January 17, 2020

Health care 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). The current the Centers for Disease Control and Prevention (CDC)s definition for a PUI is available. 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.

Specimen Type and Priority

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.

General Guidelines

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”.

I. Respiratory Specimens

A. Lower respiratory tract

Bronchoalveolar lavage, tracheal aspirate

Collect 2-3 mL into a sterile, leak-proof, screw-cap sputum collection cup or sterile dry container. Refrigerate specimen at 2-8°C and ship overnight to CDC on ice pack.

Sputum

Have the patient rinse the mouth with water and then expectorate deep cough sputum directly into a sterile, leak-proof, screw-cap sputum collection cup or sterile dry container. Refrigerate specimen at 2-8°C and ship overnight to CDC on ice pack.

B. Upper respiratory tract

Nasopharyngeal swab AND oropharyngeal swab (NP/OP swab)

Use only synthetic fiber swabs with plastic shafts. Do not use calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and inhibit PCR testing. Place swabs immediately into sterile tubes containing 2-3 ml of viral transport media. NP and OP specimens can be combined in the same vial. Refrigerate specimen at 2-8°C and ship overnight to CDC on ice pack.

Nasopharyngeal swab: Insert a swab into the nostril parallel to the palate. Leave the swab in place for a few seconds to absorb secretions. Swab both nasopharyngeal areas with the same swab.
Oropharyngeal swab (e.g., throat swab): Swab the posterior pharynx, avoiding the tongue.

Nasopharyngeal wash/aspirate or nasal aspirate

Collect 2-3 mL into a sterile, leak-proof, screw-cap sputum collection cup or sterile dry container. Refrigerate specimen at 2-8°C and ship overnight to CDC on ice pack.

II. Serum

Minimum volume required:

Children and adults: Collect 1 tube (5-10 mL) of whole blood in a serum separator tube.

Infant: A minimum of 1 mL of whole blood is needed for testing pediatric patients. If possible, collect 1 mL in a serum separator tube.

Serum separator tubes should be stored upright for at least 30 minutes, and then centrifuged at 1000–1300 relative centrifugal force (RCF) for 10 minutes before removing the serum and placing it in a separate sterile tube for shipping (such as a cryovial). Refrigerate the serum specimen at 2-8°C and ship overnight to CDC on ice-pack.

III. Shipping

Specimens PUI’s must be packaged, shipped, and transported according to the current edition of the International Air Transport Association (IATA) Dangerous Goods Regulationsexternal icon.  Store specimens at 2-8°C and ship overnight to CDC on ice pack. If a specimen is frozen at -70°C ship overnight to CDC on dry ice. Additional useful and detailed information on packing, shipping, and transporting specimens can be found at Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with 2019 Novel Coronavirus (2019-nCoV).

For additional information, consultation, or the CDC shipping address, contact the CDC Emergency Operations Center (EOC) at 770-488-7100.

 
Page last reviewed: January 17, 2020

https://www.cdc.gov/coronavirus/2019-nCoV/guidelines-clinical-specimens.html

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Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with 2019 Novel Coronavirus (2019-nCoV)

January 17, 2020

To date, we do not fully understand the pathogenic potential and transmission dynamics of 2019 Novel Coronavirus (2019-nCoV). Until more information becomes available, precautions should be taken in collecting and handling specimens that may contain 2019-nCoV. Timely communication between clinical and laboratory staff is essential to minimize the risk incurred in handling specimens from patients with possible 2019-nCoV infection. Such specimens should be labeled accordingly, and the laboratory should be alerted to ensure proper specimen handling. General and specific biosafety guidelines for handling 2019-nCoV specimens are provided below.

For additional detailed instructions please refer to the following:

General Guidelines (for working with potentially infectious materials)

Laboratory workers should wear appropriate personal protective equipment (PPE) which includes disposable gloves, laboratory coat/gown and eye protection when handling potentially infectious specimens.

Any procedure with the potential to generate fine-particulate aerosols (e.g., vortexing or sonication of specimens in an open tube) should be performed in a Class II Biological Safety Cabinet (BSC). Appropriate physical containment devices (e.g., centrifuge safety buckets; sealed rotors) should be used for centrifugation. Ideally, rotors and buckets should be loaded and unloaded in a BSC. Perform any procedures outside a BSC in a manner that minimizes the risk of exposure to an inadvertent sample release.

After specimens are processed, decontaminate work surfaces and equipment with appropriate disinfectants. Use any EPA-registered hospital disinfectant. Follow manufacturer’s recommendations for use-dilution (i.e., concentration), contact time, and care in handling.

All disposable waste should be autoclaved.

Specific Guidelines

Virus isolation in cell culture and initial characterization of viral agents recovered in cultures of 2019-nCoV specimens are NOT recommended at this time.

The following activities may be performed in BSL-2 facilities using standard BSL-2 work practices:

  • Pathologic examination and processing of formalin-fixed or otherwise inactivated tissues
  • Molecular analysis of extracted nucleic acid preparations
  • Electron microscopic studies with glutaraldehyde-fixed grids
  • Routine examination of bacterial and mycotic cultures
  • Routine staining and microscopic analysis of fixed smears
  • Final packaging of specimens for transport to diagnostic laboratories for additional testing. Specimens should already be in a sealed, decontaminated primary container.
  • Inactivated specimens (e.g., specimens in nucleic acid extraction buffer)

The following activities involving manipulation of potentially infected specimens should be performed as above and in a Class II BSC:

  • Aliquoting and/or diluting specimens
  • Inoculating bacterial or mycological culture media
  • Performing diagnostic tests that do not involve propagation of viral agents in vitro or in vivo
  • Nucleic acid extraction procedures involving potentially infected specimens
  • Preparation and chemical- or heat-fixing of smears for microscopic analysis

Clinical Laboratory Testing

Clinical laboratories performing routine hematology, urinalysis, and clinical chemistry studies, and microbiology laboratories performing diagnostic tests on serum, blood, or urine specimens should follow standard laboratory practices, including Standard Precautions, when handling potential 2019-nCoV specimens. For additional information, see Biosafety in Microbiological and Biomedical Laboratories (BMBL) – Fifth Edition (page 225).

Packing, Shipping and Transport

Packaging, shipping, and transport of specimens from suspect cases or PUI’s of 2019-nCoV infection must follow the current edition of the International Air Transport Association (IATA) Dangerous Goods Regulationsexternal icon.

Follow shipping regulations for UN 3373 Biological Substance, Category B when sending potential 2019-nCoV specimens.

Resources

 
Page last reviewed: January 17, 2020

https://www.cdc.gov/coronavirus/2019-nCoV/lab-biosafety-guidelines.html

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  • niman changed the title to CDC 2019-nCoV Case Definition and Guidance Update

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