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2019 Novel Coronavirus (2019-nCoV)

Clinical Laboratory Guidance

Clinicians caring for patients who meet the CDC criteria for Person Under Investigation (PUI) with approval from the NC Communicable Disease Branch (919-733-3419; available 24/7) to test for 2019-novel coronavirus (nCOV) should contact the North Carolina State Laboratory of Public Health (NCSLPH) (State Laboratory BTEP Duty Phone 919-807-8600; available 24/7) to coordinate the collection and shipment of specimens.

All specimens from PUI for 2019-nCoV testing at CDC must be routed through the State Laboratory for shipment to CDC until testing is available at NCSLPH.    

Specimen Collection

For initial diagnostic testing for 2019-nCoV, 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 indicated (CDC HAN dated 2/1/2020).  Specimens should be collected as soon as possible once a PUI is identified, regardless of the time of symptom onset.

  1. For sputum, have the patient rinse their mouth with water and expectorate deep cough sputum directly into a sterile collection cup.
  2. Nasopharyngeal and oropharyngeal swabs (NP/OP swabs) should be collected using only sterile synthetic (dacron or rayon) flocked swabs with plastic or metal shafts.
    • For OP, insert swab into the posterior pharynx and tonsillar areas. Rub swab avoiding contact with tongue, teeth, and gums.
    • For NP, insert swab through the nares until resistance is encountered. Gently rub and roll the swab, leaving in place for a few seconds to absorb secretions before removing.
    • Place NP and OP swabs into sterile vials (1 swab per vial) containing at least 2-3 mL of viral transport media and aseptically break the applicator sticks.
  3. All specimens must be packaged with ice packs as UN3373 Category B and shipped using the fastest possible method. Courier pickup may be coordinated with NCSLPH through communication with the BTEP duty phone.

All specimens and requisition forms must be labeled with the PUI number assigned to the patient by the CDC and/or the State Laboratory. Specimens and requisitions MUST include:

  • Patient name and a second unique identifier (birthday, medical ID)
  • Date of collection
  • Specimen type (OP swab, NP swab, or sputum, if collected)
  • PUI number

Incorrectly labeled specimens and/or incomplete specimen forms may result in a delay in testing. The State Laboratory has the authority to reject mislabeled or under-labeled specimens and request recollection of the specimen.

Required Specimen Forms

Please submit the following forms with each sample set. CDC also requires the CDC 50.34 DASH form; however, the State Laboratory will complete the CDC 50.34 DASH form using information from the required forms below:

Reporting Results for 2019-nCoV Testing at CDC

All CDC written reports with 2019-nCoV test results from a PUI will be sent to the State Laboratory ONLY using standard CDC processes.

CDC will call all positive results to the State Epidemiologist, and a written report will immediately follow to the State Laboratory. Negative results will only be electronically reported to NCLSPH. Designated 2019-nCoV report inboxes at the State Laboratory are monitored 24/7. As soon as reports are received, the State Laboratory will issue them to the Communicable Disease Branch, the submitting physician, as well as, the submitting laboratory, based upon information provided on the BTEP Clinical Submission Form.

Factsheets

Healthcare Providers

2019-nCoV Real-Time RT-PCR Diagnostic Panel for Providers

Patients

2019-nCoV Real-Time RT-PCR Diagnostic Panel for Patients

Additional Resources


SLPH Bioterrorism Information


 

NCDHHS

Updated: February 6, 2020