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The North Carolina Division of Public Health continues to work to contain the spread of COVID-19, and a big part of that effort is testing people at immediate risk for the virus. The North Carolina State Laboratory of Public Health (NCSLPH) is using the real-time RT-PCR test developed by the Centers for Disease Control and Prevention (CDC) and consistently maintains a turnaround time of 24-48 hours from time of specimen receipt to COVID-19 test result.
If you are a member of the public and you have general questions or concerns related to COVID-19 and/or testing, dial 211, 888-892-1162, or text COVIDNC to 898211. The NCDHHS Check My Symptoms tool can help determine if you will be recommended to be tested for COVID-19, and will provide a list of nearby specimen collection sites. If you need testing you can also call your doctor or your Local Health Department, or find a nearby specimen collection location at My Testing Place. Anyone interested in getting tested should call the specimen collection site before they go to learn about testing criteria, availability, hours, and location.
Yes, facilities can now request COVID-19 specimen collection supplies at the NCDHHS website.
County Health Departments, Federally Qualified Health Centers, or other facilities serving uninsured populations may elect to request NCSLPH Specimen Collection Kits. These Specimen Collection Kits must be returned to the NCSLPH for testing. Submissions to other laboratories using these specific supplies may result in specimen rejection.
County Health Departments requesting these specimen collection supplies can either use the new ordering system, or continue to submit their requests through their County Emergency Management.
The following supplies are provided in our COVID-19 specimen collection kits: collection instructions, cold packs, specimen labels, UN3373 shipping label, Styrofoam shipping container, 5 vials of Remel sterile viral transport medium, 5 sterile synthetic swabs for NP collection.
Facilities that have previously ordered and received NCSLPH COVID-19 Specimen Collection Kits can incorporate unused collection materials (including the glass vials of our yellow viral transport medium, if stored at 2-8°C, and unopened swabs) for future specimen collections.
Yes, however do not wait to batch specimens for shipment. If sending multiple specimens, each vial of viral transport medium must be clearly labeled, inside its own biohazard bag along with its COVID-19 Submission Form. Ensure that all cold packs provided have been properly frozen prior to shipment and are returned to the NCSLPH with the specimens collected. If returning large numbers of specimens to the NCSLPH at once, please package them in a way that allows for the rapid identification of which requisition form goes with which specimen.
Please see our Specimen Collection Handout and Specimen Collection Kit Instructions.
The NCSLPH kit includes a vial of Remel sterile viral transport medium containing 3mLs of liquid. Other commercially available substitutions can be found on the FDA website under “Testing Supply Substitution Strategies” slide show. Please refer to our COVID-19 form for currently accepted media types.
CMS has announced new Healthcare Common Procedure Coding System (HCPCS) codes for healthcare providers and laboratories to test patients for SARS-CoV-2. A description of the codes and test pricing can be found in the Medicare Administrative Contractor (MAC) COVID-19 Test Pricing, May 19, 2020 summary.
Yes. Please see the Specimen Collection and Shipment Handout for detailed information about specimen collection, submission, and packaging/shipping.
The NCSLPH loading dock is open for package receipt Monday - Friday from 8am - 5pm and Saturday from 8am - noon.
NCSLPH is providing county health departments with COVID-19 Specimen Collection Kits that contain everything needed for the collection, packaging and shipment of COVID-19 specimens as UN3373 Category B to the NCSLPH. All other facilities can order Cat B shipping supplies from commercial vendors. Here are some Vendor suggestions for purchasing these supplies: Saf-T-Pak through Fisher, Com-Pac, TheraPak.
The FDA website has a list of in vitro diagnostic EUAs.
The FDA has created a website detailing the performance characteristics of serologic tests that currently have an EUA, as well as provides general information. The CDC also has several resources available regarding serologic testing.
The Association of Public Health Laboratories (APHL) has published the following guidance document for facilities considering rapid antigen testing. NC DHHS also has the following guidance.
CDC has the following Antigen Test Algorithm.
No. Local health departments must only use kits that have an FDA-approved EUA. Point-of-care tests, diagnostic kits, and instruments must be approved by the FDA prior to use.
The US Department of Health and Human Services released the following guidance on June 4, 2020, and they have created an FAQ on the topic.
In North Carolina, 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 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.