ECDC Testing Criteria & Specimen Collection For Suspected Novel Coronavirus Cases

#14,663

While the extent of the threat is still poorly defined, and there are no guarantees that we are on the verge of something `big', the world's global public health agencies (WHO, CDC, ECDC, CHP, etc.) are proceeding with justifiable caution and concern as the 2019 - Novel Coronavirus has now been detected in two other countries (Thailand & Japan).

Overnight we've seen both Hong Kong and Macao announce new, more stringent measures to deal with the potential threat, and this morning the ECDC has published their epidemiological and clinical criteria for testing suspect cases, and a guide to specimen collection. 

All of this - while precautionary at this point - is absolutely imperative, else we risk being caught flat-footed should this outbreak expand. And if this novel coronavirus turns out to not be quite ready for prime time, anything we do now prepares us better for the next threat that will surely emerge.

Laboratory testing of suspect cases of 2019 nCoV using RT-PCR

Patient and case management
16 Jan 2020

The aim of these guidelines are to support EU/EEA Member States in testing of individuals for the novel coronavirus (2019-nCoV). The content is subject to change as more information becomes available from ongoing epidemiological investigations.

Prompt case confirmation is necessary to ensure rapid and effective contact tracing, implementation of infection prevention and control measures according to national recommendations, and collection of relevant epidemiological and clinical information. 

Criteria to initiate testing for 2019-nCoV

Any person fulfilling the epidemiological AND clinical criteria should be tested for 2019-nCoV. The laboratory method is provided below. The laboratory test should be initiated immediately when the below criteria are fulfilled.

Epidemiological criteria

• Any person with travel-history to Wuhan City, China in the 14 days [1] before the onset of illness

OR

• Any person being in close contact [2] with a laboratory-confirmed case of 2019-nCoV in the 14 days before the onset of illness.

Clinical criteria

• Any person with clinical symptoms compatible with severe acute respiratory infection seeking healthcare or admitted to hospital with clinical or radiological evidence of pneumonia

OR

• Any person with fever or recent history of fever (>=38°C) and acute respiratory infection (sudden onset of respiratory infection with one or more of the following symptoms: shortness of breath, cough or sore throat) 

Types of specimens

According to WHO interim guidance on laboratory testing of human suspected cases of CoV infection, rapid collection of the following specimens should be considered:

• respiratory material (nasopharyngeal and oropharyngeal swab in ambulatory patients and sputum (if produced) and/or endotracheal aspirate in patients with more severe respiratory disease);
• serum for serological testing, acute sample and convalescent sample (this is additional to respiratory materials and can support the identification of the true agent, once serologic assay is available) other specimens to consider in unresolved cases: blood for culture, urine for Legionella and pneumococcal antigen detection.
•  Respiratory specimen collection from upper and in particular lower respiratory tract, which might be preferable, should be performed under heightened infection prevention and control measures (airborne precautions) according to WHO interim guidance or national guidelines and recommendations.

Currently there is limited information about the best point in time for specimen collection. In analogy to other viral respiratory infections, it is likely that respiratory specimens collected early during the course of infection would yield higher virus concentrations. Subsequent specimens should also be collected during the course of infection.

Testing methodology

The specific tests currently recommended by WHO for the diagnosis and confirmation of 2019-nCoV are described in a dedicated WHO webpage, where the laboratory diagnostic protocol for real-time RT-PCR developed by Charité, Berlin Germany can also be found.

Additional confirmation of positive results should be performed in specialised laboratories for coronavirus e.g. as indicated below. When possible, sequence information should be generated from positive specimens and shared, to allow comparison with available sequence data. Sequencing of viral isolates should be performed by national reference laboratories or specialised laboratories experienced in handling coronavirus analysis.

Laboratory support (for primary/and or confirmatory testing) by Coronavirus specialised laboratories in the EU

Any positive test can be sent for confirmation to one of the two European expert laboratories for coronaviruses:
Charité – Universitätsmedizin Berlin Institute of Virology, Berlin, Germany
Erasmus Medical Center, Department of Viroscience, Rotterdam, the Netherlands.

[1] Limited information is available, an incubation period for 2019-nCoV up to 14 days is assumed, which is based on the knowledge of MERS-CoV and SARS-CoV epidemiology data.
[2] Close contact: family members or people living in the same household; close (2m distance) or direct contact with the person e.g. health care or laboratory worker, direct exposure to body fluids or specimens including aerosol;