Skip all navigation Skip to page navigation

DHHS Home | Assistance | Divisions | About DHHS | DHHS Contacts

NC Department of Health and Human Services
State Laboratory of Public Health
N.C. Public Health Home
 
 

Coronavirus Disease 2019 (COVID-19)

Clinical Laboratory Guidance

Testing Criteria

  • Patients must meet the testing criteria given in the currently posted provider memo (updated 07/06/2020).
  • Clinicians can submit specimens to the State Laboratory of Public Health for person with symptoms compatible with COVID-191 who are in one of the following six categories:
    1. Hospitalized patients;
    2. Healthcare workers or first responders (PDF, 1.2 MB) (e.g. EMS, law enforcement, fire department, military);
    3. Patients who live in or have regular contact with a high-risk setting (e.g. long-term care facility, homeless shelter, correctional facility, migrant farmworker camp);
    4. Persons who are at higher risk2 of severe illness and for whom a clinician has determined that results would inform clinical management;
    5. Uninsured patients; and
    6. Post-mortem specimens from patients in whom COVID-19 was suspected but not confirmed prior to death3.
  • To discuss testing through NCSLPH for patients not meeting any of these criteria, contact the Division of Public Health epidemiologist on-call line at 919-733-3419.
  • In order to systematically monitor COVID-19 virus activity in North Carolina, NCSLPH will also perform testing on surveillance specimens submitted from sites participating in the NC Influenza-like Illness Surveillance Network (ILINet).

1 People with COVID-19 have had a wide range of symptoms reported - ranging from mild symptoms to severe illness. Symptoms may appear 2-14 days after exposure to the virus. People with these symptoms may have COVID-19: Cough, shortness of breath or difficulty breathing, fever, chills, muscle pain, sore throat, new loss of taste or smell. Other less common symptoms have been reported, including gastrointestinal symptoms like nausea, vomiting, or diarrhea.

2 Testing at SLPH for asymptomatic residents or staff in congregate living facilities with cases or outbreaks of COVID-19 can be considered on a case-by-case basis in consultation with local and state public health if other testing options are not available.

3 Post-mortem testing is not routinely requested by NC DHHS but is available for situations in which a clinician has deemed such testing appropriate and if supplies for specimen collection and transport are available. Supplies for specimen collection and transport of post-mortem specimens are available through NCSLPH via local health departments. Post-mortem specimens must be collected within 72 hours of death.

Requesting Collection Supplies

  • Facilities can now request bulk specimen collection materials through a new online system managed by NCDHHS. Please see the NCDHHS website for details.
  • Local Health Departments may request bulk supplies and NCSLPH Specimen Collection Kits through their Emergency Management or through this online system. Kits come with the following Kit Instructions (PDF, 705 KB; updated 04/29/2020), and must be returned to the State Lab for testing.

Specimen Collection

Handout for Collecting and Sending COVID-19 Specimens to the NCSLPH (PDF, 1.1 MB) - Last updated 05/18/2020

Specimen Shipment to SLPH

  • Specimens should be packaged and shipped as UN3373 Category B. Please see this June 19, 2020 memo and poster from the US DOT reviewing Category B shipping and safe COVID-19 specimen transport.
  • Do not use the State Courier for shipping COVID-19 specimens.
  • Specimen deliveries will be received at the NCSLPH loading dock from 8am-5pm Monday through Friday, and 8am-12pm on Saturday and Sunday.

Specimen Rejection Criteria

  • Specimens not kept at 2-8°C (≥72 hrs) or if specimens have not been frozen at -70°C and they are >72 hrs old.
  • Incomplete specimen labeling or documentation. Unlabeled vials of VTM containing the NP swab will be rejected.
  • Inappropriate specimen type.
  • Insufficient specimen volume for testing.

Result Reporting

Clinical Laboratory Safety Guidance

Additional Information for Clinical Laboratory Testing

  • Specimens initially tested in a clinical diagnostic laboratory regulated by CLIA using a laboratory developed test (LDT) must abide by FDA regulations that require registration of the assay employed.
  • Interim Guidance Advisory: Pursuant to Session Law 2020-4 Section 4.10.(a), the Department of Health and Human Services will be requiring each person in charge of a laboratory providing diagnostic service in this State and any other health care provider licensed in this State that provides diagnostic service to report the results of all COVID-19 testing to the Department of Health and Human Services. The Department is currently testing a three-step an electronic file submission method to support this reporting requirement. Additional information about the effective date and process for this requirement are forthcoming. Meanwhile, laboratories and businesses are advised to continue their current submission process and complete the registration step from the electronic file submission method.
  • For information on serological tests for SARS-CoV-2 antibody detection, including performance characteristics, please refer to the FDA's website.
  • NCDHHS has the following guidance for SARS-CoV-2 antigen testing.
  • APHL has also provided the following guidance for rapid antigen testing for SARS-CoV-2.

For Additional Information

  • For general information, non-urgent laboratory questions about specimen collection, testing, and reporting please email the NCSLPH COVID-19 helpdesk at slph.covid19@dhhs.nc.gov.
  • For critical laboratory-related questions during normal business hours (8am - 5pm, Monday - Friday) please call the SLPH Customer Service line at 919-733-3937.
  • Please refer to our Frequently Asked Questions.
  • Providers needing consultation can call the epidemiologist on call at 919-733-3419.
  • NC DHHS Community Care of North Carolina, Inc. (CCNC) has established a toll-free helpline (877-490-6642) aimed at answering patients’ COVID-19 questions and helping them find the care they need.
  • Members of the public should call 2-1-1 or 888-892-1162 or text COVIDNC to 898211.

External Resources


 

NCDHHS

Updated: August 3, 2020