Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19)

Summary of Recent Changes

Revisions were made on March 9, 2020. to reflect the following:

Updates to all specimen storage guidelines for consistency with EUA IFU.
Recommendation to include combined NP/OP specimens as an option for upper respiratory specimen collection.

March 9, 2020

Health care providers should contact their local/state health department immediately to notify them of patients with fever and lower respiratory illness who live in or have recently traveled to an affected area with sustained transmission or have been in close contact with a confirmed COVID-19 patient. Local and state public health staff will determine if the patient meets the criteria for a person under investigation (PUI) for COVID-19. 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 COVID-19 PUIs.

Now that the CDC’s diagnostic test has been authorized by FDA under the EUA, the International Reagent Resource (IRR) has begun to distribute the test to requesting laboratories.

Clinicians who have identified a potential PUI should immediately notify their state or local health department. Local and state public health staff will determine if the person is a PUI and whether testing for COVID-19 is indicated. The state and local health department will then assist clinicians to collect, store, and ship specimens appropriately, including during afterhours or on weekends/holidays.

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

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 COVID-19 co-infections.

Specimen Type and Priority

For initial diagnostic testing for COVID-19, CDC recommends collecting and testing upper respiratory (nasopharyngeal AND oropharyngeal swabs), and lower respiratory (sputum, if possible) for those patients with productive coughs. Induction of sputum is not recommended. Specimens should be collected as soon as possible once a PUI is identified, regardless of the time 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.

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.

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 may be kept in separate vials or combined at collection into a single vial.

Nasopharyngeal swab: Insert a swab into the nostril parallel to the palate. Leave the swab in place for a few seconds to absorb secretions.
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.

II. Storage

Store specimens at 2-8°C for up to 72 hours after collection. If a delay in testing or shipping is expected, store specimens at -70°C or below.

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 Regulations. 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 Coronavirus Disease 2019 (COVID-19).

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