COVID-19 (Coronavirus Disease 2019)

 

Information updated: 04/01/2020 4:00 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). Other laboratories also providing this testing include: the City of Milwaukee Health Department Laboratory, Mayo Clinic, Quest, and LabCorp

Here at the WSLH, we use a Real-Time amplified probe-based PCR assay developed by the Centers for Disease Control and Prevention (CDC). This assay has Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration. The EUA has very strict criteria under which testing can be performed.

On March 11, 2020, the World Health Organization characterized COVID-19 a pandemic.

On March 12, 2020, Governor Tony Evers declared a State of Emergency in Wisconsin.

 

Most Recent Updates
  • Added Slides and video from the recent WCLN Webinar (Updated 4/1/20, 4:00 PM)
  • Added Wisconsin SEOC Survey for lab Capacity (Updated 4/1/20, 1:30 PM)
  • Added WI DHS 3/27/20 Updated Prioritization Guidance and Priority Table (Updated 3/29/20, 12:15 PM)
  • Added CDC Protocol for Viral Transport Media (VTM) production (Updated 3/28/20, 8:30 AM)
  • Updated Testing guidance for Clinical Labs (Updated 3/31/20, 6:00 PM)
  • Pictorial instructions for shipping added (Updated 3/22/20, 1:00 PM)

See more information below.

Contents:

CDD Customer Service Hours:

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

  • Monday-Saturday: 7:45 AM – 4:30 PM
  • Sunday: 9:00 AM – 4:30 PM

CDD Specimen Receiving Hours:

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

  • Monday-Saturday: 6:00 AM – 4:30 PM
  • Sunday: 9:00 AM – 4:30 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 volume of specimens submitted to the WSLH has exceeded our sustainable capacity resulting in our need to triage specimens. Due to the fragility of the supply chain of testing components, and in order to protect our ability to provide testing for the most critically ill, the Wisconsin Department of Health Services released a memo with updated guidelines for providers to prioritize hospitalized patients to be tested for COVID-19. http://www.slh.wisc.edu/wp-content/uploads/2020/03/200327_updated-prioritization-per-DHS.pdf (WI DHS Updated Guidance – 3/27/20)

 

Patient Triage Priority:

Only Tier One and Tier Two specimens will be tested at the WSLH.

Tier One:

  • Patient is critically ill and receiving ICU level care with unexplained viral pneumonia or respiratory failure
  • Patients who are residents of long-term care facilities or other high consequence congregate settings (e.g. prisons or jails), with unexplained fever OR signs/symptoms of acute respiratory illness.
  • Post-mortem testing for people who died of unknown causes, if COVID-19 testing would influence infection control interventions or inform a public health response

Tier Two:

  • Hospitalized (non-ICU) patients with unexplained fever AND signs/symptoms of acute respiratory illness
  • Health care workers or first responders with unexplained fever AND signs/symptoms of acute respiratory illness, regardless of hospitalization
  • Essential staff in high consequence congregate settings (e.g. correctional officers) with unexplained fever AND signs/symptoms of acute respiratory illness, regardless of hospitalization

Tier Three:

  • Patient is in an outpatient setting and meets criteria for influenza testing. This includes individuals with co-morbid conditions including diabetes, COPD, congestive heart failure, age >50, immunocompromised hosts among others
  • Health care workers with acute respiratory symptoms (e.g. rhinorrhea, congestion, sore throat, cough) without fever

Tier Four:

  • Other patients, as directed by public health or infection control authorities (e.g. community surveillance or public health investigations)

Do NOT Test:

  • Patients without symptoms
  • Patients with mild upper respiratory symptoms only who are not health care workers

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 AND include a marked copy of the Priority Table (updated by WI DHS 3/25/20) with submitted specimens.

Note: If you are requesting testing on a patient without higher risk indicators, please consider sending specimens to a commercial reference or clinical laboratory because these specimens will be considered lower priority at the WSLH not tested.

 

Lower Priority Specimens:
  • Lower priority specimens will not be tested at the WSLH, please do not submit them
  • Due to a sudden change in submission guidance, testing requests for lower priority specimen received prior to 3/21/20 will be honored. These specimen have been sent to a reference lab for testing (at no charge to the submitter)(one time only!)
  • We cannot guarantee testing for future lower priority specimens, do not send them
  • Specimens will be frozen to maintain stability
  • We will send messaging to the submitter if a specimen is deemed lower priority
  • Notify us if you want a specimen returned, you may want to find other testing options
  • If you no longer need testing on a specimen please notify us so we can remove it from our queue

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 WDPH.

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

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

 

Specimens:

If you have questions about what specimen to collect for testing, or how to submit them, contact WSLH Customer Service at 800-862-1013 during our extended business hours (Mon- Sat 7:45 AM – 4:30 PM, Sunday 9:00 AM – 4:30 PM).

Acceptable specimen types:
  • Recommended: Nasopharyngeal (NP) swab (Dacron-tipped with a plastic or aluminum shaft) in viral transport media (VTM). If VTM is unavailable UTM, Amies, or RNAse free Saline may be substituted.
  • Nasopharyngeal (NP) and oropharyngeal (OP) swabs (Dacron-tipped with a plastic or aluminum shaft), with both swabs placed in a single tube of viral transport media (VTM). If VTM is unavailable UTM, Amies, or RNAse free Saline may be substituted.
  • 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 you do not have VTM collection kits available there are several alternate options described on the FDA website: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2.

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

Note: Additional specimens such as blood products, urine and/or stool may be requested for follow-up on patients who test positive, but are not accepted for routine testing.

Note: If you do not have specimen collection supplies, they are available at the WSLH through our Clinical Orders Department at 800-862-1088. Please leave a message if outside normal business hours (Mon-Fri 7:45 AM – 4:30 PM). Do not use the emergency pager for supply ordering. Supplies are limited. Please use your own supplies if available.

 

Packaging and Shipping:

If you have questions about how to submit specimens for testing, contact WSLH Customer Service at 800-862-1013 during our extended business hours (Mon- Sat 7:45 AM – 4:30 PM, Sunday 9:00 AM – 4:30 PM).

Submit specimens with:

  1. 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 – 4:30 PM).
  2. A marked copy of the Priority Table (updated by WI DHS 3/25/20) for testing triage.
  3. PUI information may be submitted either via WEDSS (preferred) or in a PUI form sent with the specimen. A PUI form can be found at: https://www.cdc.gov/coronavirus/2019-ncov/downloads/pui-form.pdf
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

  • If the specimen will Arrive at WSLH <72 hours after collection: Either store specimens at 2-8oC and ship with chilled cold packs or freeze (-70oC) and ship on plenty of dry ice
  • If the specimen will Arrive at WSLH >72 hours after collection: Freeze (-70oC ) the specimen and ship on plenty of dry ice
  • Package as a UN3373 Biological Substance, Category B. Instructions for shipping
  • 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

**If you prefer to make your own arrangements, WSLH accepts specimens from other courier or delivery services. Please notify us of expected time of receipt at WSLH

 

Specimen Rejection Criteria:

  • Swabs not submitted in approved liquid (dry swabs)
  • Specimens without 2 patient identifiers
  • Specimens received at room temperature
  • Unfrozen specimens received at the WSLH >72 hours after collection
    • If specimen will not received at the WSLH within 72 hrs of collection, freeze the specimen immediately (-70oC) and ship on plenty of dry ice.

 

Test Results:

Currently, Tier 1 and 2 priority test results will be available within 1 – 2 days of receipt of the specimen at the WSLH. We are no longer testing lower priority specimens. 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 and health department. 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.

Test results will be reported as one of the following:

Positive – 2019-nCoV RNA detected

Negative – Negative results do not preclude 2019-nCoV infection and should not be used as the sole basis for treatment or other patient management decisions.

Inconclusive – This test result is inconclusive. It did not meet the full criteria established by the CDC for the presence of 2019-nCoV. This specimen will be sent to the CDC for additional testing. Their report will follow.

Invalid – This specimen exhibited inhibition in the PCR assay or the specimen contained an inadequate amount of clinical material. If clinically warranted, repeat testing is suggested.

The following comments will also be added to the report:

NOTE: Patients under investigation for COVID-19, and suspected or confirmed cases of COVID-19, are now 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.

NOTE: WSLH will report all of our COVID-19 test results to WEDSS.

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 WLSH strongly encourages Clinical Labs to bring on testing in their labs.

 

NEW Wisconsin SEOC Survey Tool for Lab Capacity

This tool is intended as a means to track 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 publically available. Please update the information for your lab anytime there is a significant change in testing. https://covidlabsurvey.wi.gov

  • Initial report to set the baseline
  • Starting testing with a new COVID-19 assay or platform
  • A large change in testing capacity
  • A major supply limitation affecting your ability to perform testing

 

FDA EUA Cleared Tests are available for use in Clinical Laboratories and purchase from the manufacturer. 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-authorizationshttps://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov

    • CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel (CDC)
    • Cobas SARS-CoV-2 (Roche)
    • TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
    • Panther Fusion SARS-CoV-2 (Hologic, Inc.)
    • Lyra SARS-CoV-2 Assay (Quidel Corp.)
    • Abbott RealTime Sars-CoV-2 Assay (Abbott Molecular)
    • Simplexa COVID-19 Direct (Diasorin Molecular, LLC)
    • ePlex SARS-CoV-2 (GenMark Diagnostics, Inc.)
    • Primerdesign Ltd COVID-19 genesig Real-Time PCR assay (Primerdesign Ltd.)
    • Xpert Xpress SARS-CoV-2 test (Cepheid)
    • BioFire COVID-19 test (BioFire Defense, LLC)
    • Accula SARS-Cov-2 Test (Mesa Biotech Inc.)
    • Coronavirus Nucleic Acid Detection Kit (PerkinElmer)
    • AvellinoCoV2 test (Avellino Lab USA, Inc.)
    • Real-Time Fluorescent RT-PCR Kit for Detecting SARS-2019-nCoV (BGI Genomics Co. Ltd)
    • ID NOW COVID-19 (Abbott Diagnostics Scarborough, Inc.)
    • NxTAG CoV Extended panel (Luminex Molecular Diagnostics, Inc.)
    • NeuMoDx SARS-CoV-2 Assay (NeuMoDx Molecular, Inc.)
    • QIAstat-Dx Respiratory SARS-CoV-2 Panel (QIAGEN GmbH)

Clinical Lab LDTs

  • FDA has a fast track method for CLIA labs to get EUA approval: https://www.fda.gov/media/135659/download
  • We 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

The WSLH Can Help

  • We can provide a validation panel for COVID-19 testing, please call Customer Service (1-800-862-1013, Mon- Sat 7:45 AM – 4:30 PM, Sunday 9:00 AM – 4:30 PM).

Please Notify WSLH

  • If you are already testing and experience a reagent shortage or have to stop testing
  • If you plan to change your testing or capacity (if you are currently testing)
  • When you go live with new COVID-19 testing

Clinical Lab Reporting of COVID-19 Results

In addition to reporting to a patient chart or calling the physician 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)
  • Final test results should be added to the WEDSS report (often done electronically)

 

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: Will the WSLH test for COVID-19 if only one specimen type is submitted?
A: We will test any approved NP, OP, NP/OP, sputum, or BAL specimens and do not require a minimum number of specimens to perform testing.

 

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 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 business 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: Positive results are called to WDPH and 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.

 

Q: Can the WSLH also test my specimens for Flu and other respiratory pathogens?
A: No, we do not have the capacity to perform this testing at this time. Please test for these in-house or at your reference lab.

 

Q: Can the WSLH perform 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 500 uL.

 

Q: Can I use M4, M6, or eSwabs?
A: Any sterile VTM, UTM, Amies, or Saline is acceptable. VTM is preferred. Please do not use the nasal swabs. A Nasopharyngeal swab is needed for an accurate result.

 

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:

4/1/20 WCLN COVID-19 Webinar and Slides (webinar held on 4/1/20, 12:00 PM Noon) NOTE: Information in this webinar may be outdated due to rapidly evolving situation. Please refer to information above for most recent guidance.

3/25/20 WCLN COVID-19 Webinar and Slides (webinar held on 3/25/20, 12:00 PM Noon) NOTE: Information in this webinar may be outdated due to rapidly evolving situation. Please refer to information above for most recent guidance.

3/18/20 WCLN COVID-19 Webinar and Slides (webinar held on 3/18/20, 12:00 PM Noon) NOTE: Information in this webinar may be outdated due to rapidly evolving situation. Please refer to information above for most recent guidance.
3/13/20 WCLN COVID-19 Webinar and Slides (webinar held on 3/13/20, 12:00 PM Noon) NOTE: Information in this webinar may be outdated due to rapidly evolving situation. Please refer to information above for most recent guidance.

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