Clinical COVID-19 (Coronavirus Disease 2019)

 

Information updated: 09/25/2020 5:00 PM

A note to patients: Please do not contact the WSLH directly for test results. We can only give your results to the healthcare provider who sent us your specimen. They will provide you with your test result.

 

The Wisconsin State Laboratory of Hygiene (WSLH) Communicable Disease Division is currently testing for the virus that causes COVID-19 (Coronavirus Disease 2019). We use Real-Time amplified probe-based PCR assays developed by the Centers for Disease Control and Prevention (CDC), the TaqPath COVID-19 ThermoFisher assay, and the Panther TMA SARS-CoV-2 Assay to detect SAR-CoV-2 nucleic acid in patient respiratory specimen. These assays have Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration. We currently only accept specimens that fit the testing criteria outlined by Department of Health and Human Services.

 

Recent Updates
  • Added the Hologic Panther TMA Assay (Updated 09/25/20, 5:00 PM)
  • Updated Antigen testing implementation guidance (Updated 09/25/20, 5:00 PM)
  • Added descriptions to the webinars (Updated 09/12/20, 6:00 PM)
  • Added link to test performance and population prevalence (Updated 09/11/20, 11:00 AM)
  • Extended room temp stability in CDC protocol VTM to 5 months (Updated 09/04/20, 3:45 PM)
  • Added recent COVID-19 webinar recording and slides (Updated 09/03/20, 10:45 PM)
  • Updated Wisconsin SEOC Survey for lab Capacity (Updated 8/17/20, 5:00 PM)

See more information below.

Contents:

CDD Customer Service Hours:

  • Monday-Friday: 7:45 AM – 4:30 PM

CDD Specimen Receiving Hours:

Note: Extended weekend hours are for COVID-19 testing only.

  • Monday-Friday: 6:00 AM – 4:30 PM
  • Saturday: 6:30 AM – 12:30 PM
  • Sunday: 9:00 AM – 12:30 PM

Contact Information:

  • CDD Customer Service: 1-800-862-1013
  • Clinical Orders: 1-800-862-1088
  • Emergency Pager: 1-608-263-3280
  • Gold Cross Courier: 1-715-839-9989

Testing Guidance:

The Wisconsin Department of Health Services set guidelines for specimen types acceptable for testing at Wisconsin public health laboratories. We will test patients that meet one or more of the criteria below. We encourage labs to use in-house testing whenever possible. Patients that do not meet the high priority testing criteria below may still warrant testing at another facility. For additional information of testing guidance see the Wisconsin Health Alert Network communications here.

 

Patients tested by WSLH: Printable handout

  • Public Health Investigations as directed by state or local public health
  • Hospitalized patient with COVID-19 symptoms
  • Patient with COVID-19 symptoms for whom rapid diagnosis is needed to inform infection control practices
    (e.g. labor and delivery, dialysis, aerosol-generating procedures, etc.)
  • Resident of a long-term care facility with COVID-19 symptoms
  • Resident in a jail, prison, or other congregate setting with COVID-19 symptoms
  • Health care worker or first Responder (e.g. fire, EMS, police) with COVID-19 symptoms
  • Essential staff in high consequence congregate settings (e.g. prisons or jails) with COVID-19 symptoms
  • Utility workers (water, sewer, gas, electric, power, distribution of raw materials, oil and biofuel refining) with COVID-19 symptoms
  • Underserved populations with poor access to testing (e.g., underinsured, patients at Federally Qualified Health Centers, homeless patients, migrant workers, etc.) with COVID-19 symptoms
  • Post-mortem testing for a person with COVID-19 symptoms prior to death who died of unknown causes or where results would influence infection control interventions at a facility or inform a public health response. Please refer to DHS guidance.

Note: Please document the specific risk in the “Other” section on the WSLH requisition Form A where you write in your request for COVID-19 testing.

Note: If testing is needed on a patient without these indicators, please consider testing in-house or sending specimens to a reference laboratory. These specimens will not be tested or forwarded by WSLH.

 

If you have questions about COVID-19 or patient prioritization, or if you feel your patient needs urgent testing, contact a Wisconsin State Epidemiologist at WDHS.

WDHS COVID-19 Outbreak webpage with case counts: https://www.dhs.wisconsin.gov/outbreaks/index.htm

Additional DHS testing guidance on Asymptomatic people: https://content.govdelivery.com/accounts/WIDHS/bulletins/293c483

  • During normal business hours, call 608-267-9003
  • After hours, for urgent matters, call the 608-258-0099 emergency pager and ask for the epidemiologist on call.

 

Wisconsin Reference Laboratories

 

Acceptable Specimen Types:

If you have questions about what specimen to collect for testing, or how to submit them, contact WSLH Customer Service at 800-862-1013

  • Recommended: Nasopharyngeal (NP) swab (Flocked, Dacron-tipped with a plastic or aluminum shaft) in viral transport media (VTM). (Clinician collected)
  • Oropharyngeal (OP) swabs (Dacron-tipped with a plastic or aluminum shaft), in VTM. (Clinician collected)
  • Nasal swabs (Dacron-tipped with a plastic or aluminum shaft), in VTM if other swabs are not available. (Clinician collected or clinician observed self-collected)
  • Sputum or other lower respiratory specimen such as bronchoalveolar lavage or aspirate. (Induction of sputum is not indicated) (Does not need VTM)
  • For postmortem testing, collect an NP swab in viral transport media (VTM). If autopsy is performed also swab the bronchioles of each lung and place in a single VTM tube. CDC Postmortem testing guidance is available at https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-postmortem-specimens.html

Note: If VTM is unavailable UTM, Amies, or sterile RNAse free Saline or PBS may be substituted.

Note: If you do not have VTM collection kits they are available for order from WSLH (limited) or from the SEOC distribution center (see below).

Note: The CDC has a protocol for making your own VTM. https://www.cdc.gov/coronavirus/2019-ncov/downloads/Viral-Transport-Medium.pdf

Swab Snapping Instructional Videos

It is important to leave the tip of the swab in the transport tube after collecting a sample. Printable instructions and short videos of swab snapping are available for 3 common swab types.

Swab with score mark

Swab with no score mark

Swab thinner near the top

 

Collection Kits available for order from SEOC Distribution Center

The State Emergency Operations Center (SEOC) is working to make emergency supplies available to medical systems throughout Wisconsin. Quantities are limited and available on allocation. These supplies are meant as a temporary assistance to facilitate testing statewide. They are not intended to replace current supply streams. The supplies are available at no charge. To order supplies go to the ordering web portal. Please use your own supplies if available.You cannot bill for these supplies. For questions contact their email WICOVIDTEST@wi.gov

  • Commercial Kits: commercial viral transport media (VTM) and a nasopharyngeal (NP) swab. Room temp storage. Limited supply
  • Locally Made Kits: VTM (CDC protocol) and an FDA approved NP swab. NOTE: Room temp stable up to 4 months, refrigerated for 12 months. Gentueri package insert., WVDL package insert.
  • Exact Sciences Kits: Sterile 0.9% saline and a nasal swab. NOTE: Supplies intended for testing performed at Exact Sciences only. Public Health approved fee exempt testing available.
  • Swab Only: Nasopharyngeal or nasal swabs (FDA approved)
  • VTM Only: VTM (CDC protocol). NOTE: Room temp stable up to 4 months, refrigerated for 12 months
  • Category B Shipping supplies: Insulated coolers (small and large) with category B label, cool packs (freeze before use), and biohazard specimen bags.

 

Packaging and Shipping:

If you have questions about how to submit specimens for testing, contact WSLH Customer Service at 800-862-1013

Submit specimens with a completed WSLH Requisition Form A (#4105). Please write “COVID-19” under the Other Tests section of the form along with specific risk factors. If your laboratory doesn’t already have this form, please call WSLH Clinical Orders at 800-862-1088 during normal business hours (Monday – Friday 7:45 AM – 2:45 PM). Please leave a message outside of normal business hours.

  • If the specimen will Arrive at WSLH <72 hours after collection: Store specimen at 2-8oC and ship with frozen cold packs
  • If the specimen will Arrive at WSLH >72 hours after collection: Freeze (-70oC ) the specimen and ship on plenty of dry ice
  • Urgent Testing Requests – If WDPH determines that testing is urgent, WSLH will work with you to arrange transportation of the specimen. Do not contact Gold Cross courier on your own and order a STAT pick-up. STAT pick-ups can only be ordered by WSLH.
  • Extended weekend hours are for COVID-19 specimens only
  • Package as a UN3373 Biological Substance, Category B. Instructions for shipping and DOT Safety advisory
WSLH accepts specimens from many courier and delivery services.

If you are not able to make your own arrangements, fee-exempt courier service is available to WSLH through Gold Cross. If you prefer to make your own arrangements, please notify us of the expected time of receipt at WSLH.1-800-862-1013

 

Extended Gold Cross Courier Schedule:

Order by NOON for same-day pick-up for NEXT DAY delivery (7 days a week) – Gold Cross Courier 715-839-9989

Specimen Rejection Criteria:

  • Swabs not submitted in approved liquid (dry swabs)
  • Unvalidated specimen types (mid-turbinate swab, tongue swab, saliva, calcium alginate swabs, cotton tips, or wood shafts)
  • Specimens without 2 patient identifiers
  • Specimens received at room temperature

 

Test Results:

Currently, test results will be available within 1 – 2 days of receipt of the specimen at the WSLH. Positive, Inconclusive, and Invalid results will be called to the submitter immediately. All results will be reported electronically, as soon as they are available, to the submitting lab, the health department, and HHS. Please call WSLH Customer Service at 800-862-1013 if you feel a result is missing. If there are urgent questions outside of business hours you may call the WSLH emergency pager at 608-263-3280.

NOTE: Patients with suspected or confirmed COVID-19 are reportable conditions in accordance with Wis. Stat. Ch. 252 and Wis. Admin. Code Ch. DHS 145. All suspect patients should be reported to WEDSS immediately. This is normally done by an Infection Preventionist or the Clinical Provider. WSLH will also report all of our COVID-19 test results to WEDSS, CDC, and HHS.

NOTE: If you are performing testing, please report all results in the weekly surveillance report to WSLH.

 

Biosafety Considerations:

CDC biosafety guidance can be found at https://www.cdc.gov/coronavirus/2019-nCoV/lab/lab-biosafety-guidelines.html. We strongly encourage each laboratory to perform a risk assessment for their facility and the procedures they will perform on a suspect COVID-19 patient. After performing this risk assessment you may choose to implement additional biosafety practices, such as enhanced PPE, when working with suspect COVID-19 patients/specimens. A clinical laboratory biosafety Risk Management Program Assessment Checklist is available for use https://www.aphl.org/programs/preparedness/Biosafety-and-Biosecurity/Documents/Clinical_Lab_Assessment_Checklist_Final.pdf.

 

Testing in Your Clinical Lab:

To meet the growing need for COVID-19 testing the WSLH strongly encourages Clinical Labs to bring on NAAT testing in their labs.

 

IMPORTANT Wisconsin SEOC Survey Tool for Molecular Testing Lab Capacity https://covidlabsurvey.wi.gov

This tool is intended as a means to track molecular COVID-19 testing capacity and supply needs in the State of Wisconsin. This data will be used to inform on supply procurement strategies and resource allocation. Individual lab information will only be viewable to Public Health Agencies. Aggregate data for the State will be publicly available. Please update the information for your lab under the following scenarios:

  • Initial report to set the baseline (even if you don’t plan to test)
  • When you start testing with a new COVID-19 assay or platform
  • When you increase or decrease your testing capacity
  • To report or remove a major supply limitation affecting your ability to perform testing

Survey Results: capacity summary, instrument usage, and number of labs testing (updated every 15 min)

 

Hundreds of FDA EUA Cleared Tests are available for use in Clinical Laboratories. Check the FDA Website for the most up to date list of approved tests: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations

APHL Side-by-side comparison of test methods

FDA Reference panel comparison data

Test performance and population prevalence calculation tool

  • Molecular open platform assays
  • Self contained molecular assays
  • Serology assays (not approved for diagnosis)
  • Antigen assays- Implementation Guidance, State guidance

    • Sofia 2 SARS Antigen FIA (Quidel Corporation)
    • Veritor Rapid Detection of SARS-CoV-2 (BD)
    • LumiraDx SARS-CoV-2 Ag test (LumiraDx)
    • BinaxNOW COVID-19 Ag card (Abbott)

Clinical Lab LDTs

  • FDA has a fast track method for CLIA labs to get EUA approval: https://www.fda.gov/media/135659/download
  • WSLH can provide confirmatory testing for labs bringing up LDT COVID-19 PCR testing
    • Current FDA LDT EUAs require confirmation of the first 5 positives and first 5 negative results at a lab running an EUA assay

Need validation samples?

  • WSLH will provide a validation panel of de-identified residual specimen for Wisconsin clinical labs bringing up COVID-19 molecular testing. Please call Customer Service (1-800-862-1013, Monday – Friday, 7:45 AM – 4:30 PM, Saturday, 7:45 AM – 12:30 PM).

Clinical Lab Reporting of COVID-19 Results

In addition to internal reporting please report:

  • All results generated in your lab in the existing weekly surveillance report to WSLH
  • All suspect patients should be immediately reported to WEDSS (usually done by an Infection Preventionist or the Provider)
  • All molecular test results and positive serology results should be submitted to WEDSS (electronically by ELR or manually by WLR)

 

Frequently Asked Questions (FAQs)

Q: Are COVID-19, nCoV 2019, and SARS-CoV-2 the same thing?

A: COVID-19 stands for Coronavirus Disease identified in 2019. It is the disease caused by the virus SARS-CoV-2 formerly called nCoV 2019 or Novel Coronavirus 2019.

 

Q: Is FDA EUA clearance required to bring up an LDT for COVID-19?
A: Yes, you must either submit for FDA EUA approval or you can use an FDA EUA cleared assay produced commercially. Several commercial products have already submitted applications to the FDA for EUA clearance. Also, multiple commercial labs are offering this testing for clinical use and have FDA EUA approval.

 

Q: How much does the WSLH COVID-19 test cost?
A: COVID-19 testing is fee exempt at the WSLH. We can also provide collection kits and transportation of specimens free of charge. Please contact our Customer Service department if you need help setting this up – (800) 862-1013.

 

Q: How long will it take to get my results?
A: Our current turnaround time is 1-2 days from receipt in the lab. This is subject to test volume. If we see a large volume of testing, then testing results may be delayed.

 

Q: To whom does the WSLH report results?
A: At WSLH positive results are called to the submitting laboratory. The submitting laboratory is responsible for reporting to the ordering clinician. All positive and negative results are also reported electronically by ELR to WEDSS and faxed or sent electronically to the submitting labs. De-identified results are also reported to the CDC.

 

Q: Can the WSLH perform COVID-19 testing on residual specimens after Flu testing is performed?
A: Yes, we will test residual primary specimen even if some volume has been used for other tests. Minimum volume is 1 mL. Please maintain PCR sterility.

 

Q: Will my specimens expire if testing is not performed within 72 hours of collection?
A: Specimens will not expire while at WSLH. As long as specimen are stored 2-8 C and we receive them within 72 hours after collection, we will either test immediately or store specimens at -70C to allow for later testing. You can also freeze your specimens and ship on dry ice to ensure specimen stability.

 

Other Resources:

Information in these webinars may be outdated due to the rapidly evolving situation. Please refer to information above for most recent guidance.

09/02/20 WCLN COVID-19 Webinar – Antigen testing and PPV Slides

06/24/20 WCLN COVID-19 Webinar – Reporting, Shipping, and testing at WSLH Slides

05/27/20 WCLN COVID-19 Webinar – Waves of cases, Pooling, reporting, and test of cure Slides

05/13/20 WCLN COVID-19 Webinar – Community testing and HHS reporting Slides

04/29/20 WCLN COVID-19 Webinar – Dr. Bateman, Serology and SEOC Webportal Slides

04/22/20 WCLN COVID-19 Webinar – Antibody testing Slides

04/15/20 WCLN COVID-19 Webinar – Reporting and update from DHS Slides

04/08/20 WCLN COVID-19 Webinar – PIF, SEOC Survey, and Serology Slides

04/01/20 WCLN COVID-19 Webinar – PIF, SEOC Survey, and WSLH testing Slides

03/25/20 WCLN COVID-19 Webinar – Triage, alternate collection kits, and validation panels Slides

03/18/20 WCLN COVID-19 Webinar – Triage, FDA tests, and CPT codes Slides

03/13/20 WCLN COVID-19 Webinar – Pandemic declared, where to test and how Slides

 

Wisconsin Department of Health Services (WDHS) COVID-19 and Outbreaks in Wisconsin

CDC COVID-19 information

Johns Hopkins visual website for tracking COVID-19 cases

World Health Organization COVID-19 situation reports

FDA Emergency Use Authorization for test to detect the virus that causes COVID-19