Wisconsin Lab Network Feeds Valuable Data to State Health Lab

Clinical labs help coordinate state’s response to COVID-19

CEO SUMMARY: From the earliest days of the COVID-19 pandemic, the 138-member Wisconsin Clinical Laboratory Network has reported to the state health lab the number of COVID-19 tests, the number of positive results, as well as other data that includes data on lab testing supplies and capacity. Founded 20 years ago, the network is a public-private partnership that allows participating labs to identify supply shortages, exchange test supplies when needed, and enlist state officials to ask vendors to boost supply shipments.

IF TIMELY AND DETAILED CLINICAL LAB TEST DATA IS KING DURING A PANDEMIC, then the experience of the 138 labs in the Wisconsin Clinical Laboratory Network (WCLN) since the earliest days of the COVID-19 pandemic demonstrates the truth of that statement.

This is also a story about how a 20-year history of interaction and collaboration between different hospital labs and their state’s public health laboratory enabled all participants to share ideas on where to get supplies, how to introduce new tests to identify infected patients, and ways to get the most from the lab-testing equipment they have.

In most states, collaboration among clinical laboratories is mostly uncoordinated. But not in Wisconsin where the Wisconsin State Laboratory of Hygiene (WSLH) at the University of Wisconsin-Madison has fostered cooperation among the state’s 138 clinical labs for more than 20 years through the WCLN.

The network’s stated purpose is to provide communication and support to clinical laboratories to ensure timely and effective responses to public health needs, including emergency preparedness and disease surveillance. In this way, the WCLN serves as a critical resource for the state’s clinical laboratories by assisting state health officials in responding to the coronavirus pandemic, which may be the most significant challenge the network has ever faced.

State officials and clinical lab scientists in Wisconsin have learned at least three important lessons from the close working relationship that the WCLN member labs have with the state health lab.

Lessons Learned

These lessons could be applied in other states seeking to coordinate SARS-CoV-2 testing and infectious-disease data reporting to assist with surveillance and control of outbreaks. First, the network’s participating laboratories regularly report test volume, test capacity, and which labs are unable to test because lab test supplies have run short.

Using that data allows state officials to ask the manufacturers of lab test reagents (or kits) directly for more supplies. In some cases, even Wisconsin Gov. Tony Evers has intervened by writing to the manufacturers about the pressing need for more tests and more test supplies, said Alana Sterkel, PhD, D (ABMM), SM (ASCP)  CM, an Assistant Director of the Communicable Disease Division at the state lab.

Second, early during the pandemic,¬†data from WCLN member labs helped¬†WSLH recognize that certain supplies‚ÄĒsuch as specimen-collection swabs and¬†viral transport media‚ÄĒwere needed in¬†vast quantities. That information led to a¬†contract with two Wisconsin companies,¬†Gentueri and WVDL, neither of which¬†made these supplies before state officials¬†asked them to make enough supplies to¬†support the testing statewide.

Labs with Supply Shortages

Third, WSLH uses WCLN data to identify¬†which labs have shortages and which labs¬†have supplies or may soon run out.¬†‚ÄúThis information has allowed WSLH¬†to facilitate trades between labs to optimize¬†the limited resources we have available,‚Ä̬†Sterkel explained.

Since the WSLH ran its first SARSCoV-2 test on March 2, data from the WCLN has helped state health officials to understand where the virus was spreading, how clinical laboratories were responding to the outbreak, and what those laboratories needed to increase and continue testing.

‚ÄúHaving this regional laboratory network¬†allows us to develop a robust public¬†health response that has been mutually¬†beneficial, not only for state health officials,¬†but also for the clinical labs themselves,‚Ä̬†added Sterkel.¬†‚ÄúAs a subject matter expert in lab testing,¬†I‚Äôve been embedded in the state‚Äôs¬†Emergency Operations Center (SEOC)¬†and so have been in contact with the¬†White House and federal agencies such¬†as the Federal Emergency Management¬†Agency,‚ÄĚ Sterkel said in an interview with¬†The Dark Report.

Survey of State’s Labs

Lab data posted on the state health website is derived from a survey that WCLN member labs complete. The survey is used to provide information to state decision-makers as often as needed and at any time, Sterkel explained.

‚ÄúWe ask that labs update their survey¬†answers anytime there is a change, such¬†as when they go live with testing, when¬†they change testing, or to report supply¬†shortages,‚ÄĚ she said. ‚ÄúIn a weekly report¬†to WCLN member labs, we summarize¬†lab surveillance data based on what the¬†clinical labs report to us.‚ÄĚ

State officials and the public can monitor testing trends on the DHS COVID-19: Wisconsin Summary Data page, which updates daily at 2 p.m. Data from the last week of June provides a useful example. In that week, officials in all but five states saw a spike in COVID-19 cases and positive test results, while rates of infection due to the SARS-CoV-2 coronavirus had been dropping in Wisconsin.

Efforts to Manage Outbreak

‚ÄúThose declining rates in Wisconsin came¬†as a result of efforts to increase testing,¬†institute stay-at-home orders, and conduct¬†contact tracing,‚ÄĚ she said. ‚ÄúUntil¬†recently, we‚Äôve seen a drop in the number¬†of COVID-19 tests. But, along with the¬†spike in new cases we see testing increase¬†again,‚ÄĚ noted Sterkel.

‚ÄúFor the week ending Aug. 14, labs¬†reported running an average of 10,000¬†test per day for a total of more than 1.08¬†million by Aug. 19 and had a percent positivity¬†of 6.2% overall for the whole state.¬†‚ÄúAlso, we had a seven-day average¬†of 7.7% positive results on Aug. 19,‚ÄĚ she¬†reported. ‚ÄúAt the moment, our rate of¬†positive results is concerning.‚ÄĚ

‚ÄúOn the state Department of Health¬†Services webpage, you can see that¬†COVID-19 cases have risen and fallen in¬†fits and starts,‚ÄĚ Sterkel observed.¬†‚ÄúThere is an interesting correlation¬†between the rise in cases and how mobile¬†Wisconsin residents are. A big part of¬†how we‚Äôve controlled the disease has been¬†a combination of all public health efforts,¬†and testing is a key part of the whole¬†strategy.‚ÄĚ

WSLH went live with testing on March 2, using the initial CDC assay. In the following weeks, the number of labs running the molecular tests rose from two on March 2, to 50 on April 25, to 75 by June 27, and to 83 on July 13.

Lab Test Capacity

WCLN data show clinical lab capacity in¬†a variety of ways. ‚ÄúWe can see‚ÄĒand the¬†public can see as well‚ÄĒwhich instruments¬†those labs are using and which they plan¬†to use in the future if they had the supplies¬†they need,‚ÄĚ she commented.¬†‚ÄúCurrently, 83 labs are actively testing,¬†and 27 more plan to bring up testing,¬†except they don‚Äôt have enough supplies,‚Ä̬†Sterkel reported. As of Aug. 19, the network-member labs had the capacity to¬†run 27,211 molecular COVID-19 tests¬†per day.

‚ÄúFrom that data, the clinical laboratories¬†can report when they‚Äôre experiencing¬†shortages if they‚Äôre not getting certain¬†kinds of supplies,‚ÄĚ said Sterkel. ‚ÄúWe can¬†use that data to advocate on their behalf¬†to get them the quantities of supplies they¬†need to increase testing capacity.

‚ÄúMost laboratories in Wisconsin¬†are using the Cepheid GeneXpert system,‚Ä̬†Sterkel added. ‚ÄúMany more labs¬†would like to use the Cepheid test, but¬†the supplies have been slow to come to¬†Wisconsin,‚ÄĚ she warned. ‚ÄúThis is an area¬†the SEOC is focusing on so that we can¬†increase supply allocations for the clinical¬†laboratories that need them.

‚ÄúThe numbers tell us how many of¬†the labs in the network are using the¬†Cepheid GeneXpert and how many labs¬†need supplies for that test,‚ÄĚ she commented.¬†‚ÄúBased on this information, we¬†asked the governor to write to Cepheid to¬†request more tests or other supply allocations.¬†Or, the governor could ask how we¬†could work with Cepheid to help them to¬†meet our needs.

‚ÄúJust seeing those needs allows us to¬†monitor in real time when a lab is no longer¬†able to test because they‚Äôve run out of¬†supplies,‚ÄĚ she said.¬†‚ÄúEven in my lab, we had a very limited¬†supply of extraction reagents early on,‚Ä̬†she noted. ‚ÄúAlso, we had more plastics¬†than liquids. At the same time, a clinical¬†laboratory nearby had more liquids than¬†plastics. Both of us were going to run out¬†of testing supplies. So, we did a trade that¬†allowed us to continue COVID-19 testing.¬†This redistribution allowed both of our¬†labs to keep going,‚ÄĚ Sterkel reported.

Collaborative Approach

The collaborative approach has worked¬†well during the pandemic. ‚ÄúWe have been¬†building up testing in the clinical labs and¬†in some commercial labs as well,‚ÄĚ she¬†noted.¬†‚ÄúThe advantage of working with our¬†clinical and commercial labs is that those¬†SARS-CoV-2 tests are close to where the¬†patients are. That means we can give people¬†the fastest turnaround time and the¬†closest connection to medical care that we¬†can provide.‚ÄĚ

For COVID-19 tests that must be sent¬†out, slower-than-usual turnaround times¬†at national reference labs have frustrated¬†Wisconsin‚Äôs pathologists and clinical lab¬†directors.¬†‚ÄúIt‚Äôs a constant problem for clinical¬†laboratories in our state,‚ÄĚ Sterkel said of¬†the limited supplies and kits. ‚ÄúWe‚Äôve been¬†monitoring the supply shortages as much¬†as we can and we hoped that the supply¬†constraints we saw earlier would be lifted¬†by now. But some supplies are still coming¬†in at a trickle.

‚ÄúThe result is that our clinical labs¬†have taken on diverse strategies by doing¬†testing on multiple different platforms,‚Ä̬†she reported. ‚ÄúHere at the state laboratory,¬†we‚Äôve developed COVID-19 testing on six¬†different methods. This means that as the¬†test supplies dry up on one method, we¬†can switch to another without having to¬†stop testing.

Send-Out Testing

‚ÄúOther lab facilities are trying to take that¬†same approach,‚ÄĚ she said. ‚ÄúIf they don‚Äôt¬†have another test to use, they have to send¬†out COVID-19 tests to reference laboratories.¬†Some labs are sending testing to¬†two or three different places depending¬†on availability, pricing, and turnaround¬†times, among other factors.

‚ÄúBut with some of the national reference¬†labs, it can take seven to 10 days to¬†get a result back, at least in the beginning,‚Ä̬†she added. ‚ÄúFortunately, that turnaround¬†time seems a bit better now, but it‚Äôs still¬†three to four days for a large out-of-state¬†reference lab.‚ÄĚ

Among Sterkel‚Äôs concerns about¬†the near future is how Wisconsin‚Äôs labs¬†will respond when pressed to increase¬†COVID-19 testing when schools reopen¬†and during the flu season this fall.¬†‚ÄúIt‚Äôs inevitable that the influenza will¬†come back this fall. What‚Äôs that going to¬†look like?‚ÄĚ she asked. ‚ÄúAnd how will we¬†manage our COVID testing when people¬†are symptomatic for COVID and other¬†respiratory viruses?

‚ÄúHere at the state laboratory, we‚Äôre¬†working to bring on combined multiplex¬†testing that can test for COVID and the¬†flu at the same time,‚ÄĚ she reported. ‚ÄúWe‚Äôre¬†also working with our clinical labs to help¬†them develop strategies for how they‚Äôre¬†going to manage these patients as well as¬†the increased volume that we expect in¬†the fall.‚ÄĚ

Possible Multiplex Test

One solution Sterkel and other lab professionals¬†have considered for multiplex¬†testing is the Cepheid GeneXpert system¬†because the manufacturer announced in¬†June that it was developing the Xpert¬†Xpress SARS-CoV-2/Flu/RSV four-inone¬†test. ‚ÄúThat could be a useful test,‚Ä̬†commented Sterkel.

The company expects the assay to¬†detect SARS-CoV-2, Flu A, Flu B, and¬†respiratory syncytial virus (RSV) from a¬†single patient sample. Patients with any¬†of these infections have similar clinical¬†presentations, Cepheid explained.¬†Many WCLN-member labs have run¬†Cepheid‚Äôs Rapid SARS-CoV-2 test on the¬†company‚Äôs GeneXpert systems. ‚ÄúThat test¬†is really fast in that it delivers a result in¬†about 40 minutes, and it‚Äôs trusted and¬†accurate,‚ÄĚ Sterkel commented.

Demand for Lab Instruments

‚ÄúIt‚Äôs available widely because Cepheid¬†machines were already placed in many¬†labs around the state, meaning it‚Äôs a great¬†way to get testing done everywhere,‚Ä̬†she added. State data show that other¬†machines in high demand are BioFire and¬†the Hologic Panther.

Since March, the WSLH has been¬†seeking to buy two Hologic machines but¬†found demand outstripped supply. ‚ÄúWe¬†had to get in line behind 200 other labs¬†that put in orders for these instruments,‚Ä̬†she noted. ‚ÄúThat shows there‚Äôs definitely¬†a demand for the instrumentation associated¬†with COVID testing.‚ÄĚ

WCLN survey data show which labs are running which tests. As of Aug. 19, the top five tests were in use at 52 member labs running the Cepheid machines, while 32 labs were planning to add testing from Cepheid.

The data also showed: 18 labs were running the Abbott ID NOW and 16 wanted to do so. The BD Max: nine now and none planning to add that test. The BioFire: eight now and 17 planning. And the Hologic Panther: eight now and 10 planning to add that test.

‚ÄúThe BioFire test is a fairly fast, one-hour¬†assay that‚Äôs easy to use. But that test¬†has been slow to come on the market. So,¬†if the BioFire equipment is all they have,¬†they can‚Äôt test until they get the assay,‚Ä̬†Sterkel said.

‚ÄúWisconsin received some BioFire¬†supplies, but 17 labs are still waiting to get¬†these supplies,‚ÄĚ she said. ‚ÄúSo, there‚Äôs definitely¬†a gap for getting the supplies where¬†they‚Äôre needed.‚ÄĚ

The Cepheid GeneXpert is another¬†example of a test for which supplies often¬†run short. ‚ÄúAlthough we have 52 labs running¬†that test now, some labs have had to¬†stop testing because they haven‚Äôt received¬†enough of those tests to keep up with the¬†demand,‚ÄĚ she said.

Supply Chain Challenges

‚ÄúEven labs that have received some testing¬†cartridges have stopped getting the supplies¬†they need, and so they‚Äôve stopped testing,‚Ä̬†explained Sterkel. ‚ÄúIt‚Äôs difficult to bring on a¬†test and then have to stop again. Physicians¬†get accustomed to using that test, and they¬†may prefer it because it‚Äôs fast and reliable.¬†Another test may take longer and not have¬†the same result profile.‚ÄĚ

Data from Wisconsin Clinical Lab Network Shows the COVID-19 Test Methods Being Used

BECAUSE OF HOW WISCONSIN’S DEPARTMENT OF HEALTH SERVICES (DHS) collects data about¬†COVID-19 testing, it is possible to see the number of labs using tests supplied by¬†different in vitro diagnostics (IVD) manufacturers.¬†Below is a chart produced from data that can be viewed on the DHS website. The chart¬†shows ‚Äúactive test methods statewide‚ÄĚ and shows the number of labs using COVID-19¬†tests from different manufacturers. The chart indicates that just a handful of companies¬†provide the largest proportion of COVID-19 tests to those labs that report to the DHS.

Wisconsin State Laboratory of Hygiene Asked Governor to Help Ease Supply Shortage

LEVERAGING THE CLOUT OF THE WISCONSIN STATE GOVERNMENT  has helped the Wisconsin State Laboratory of Hygiene (WSLH) to address COVID-19 shortages of supplies and tests in two ways. One was to have the state contract directly with supply manufacturers. The other was for state labs to enlist the help of Gov. Tony Evers.

‚ÄúFrom the first days, supplies ran short¬†and we had limited shipments coming¬†from our normal commercial sources,‚Ä̬†said Alana Sterkel, PhD, D (ABMM),¬†SM (ASCP) CM, Assistant Director in the¬†Communicable Disease Division of the¬†Wisconsin State Laboratory of Hygiene.¬†‚ÄúSo, we worked out a relationship with¬†two local businesses in Wisconsin that¬†make specimen collection kits‚ÄĒalthough¬†not necessarily kits for COVID-19 testing,‚Ä̬†she recalled.

‚ÄúWe asked them to switch over to producing¬†collection kits for COVID-19 testing¬†and we helped them get up and running.¬†‚ÄúOne of our local companies‚ÄĒ¬†Gentueri‚ÄĒcould source FDA-approved¬†swabs from China,‚ÄĚ she said. ‚ÄúThis¬†was essential to the success of this¬†endeavor.‚ÄĚ

‚ÄúThe Wisconsin Veterinary Diagnostic¬†Laboratory also stepped up to establish a¬†new production system for collection kits.¬†This is not their normal type of business,¬†but they wanted to help,‚ÄĚ she¬†said. ‚ÄúWe then partnered with the state‚Äôs¬†Emergency Operations Center to get the¬†supplies out to where they were needed¬†most.‚ÄĚ

The second way to improve the supply¬†chain was to ask Evers to intervene.¬†‚ÄúThe governor has worked with us to¬†send letters about our requests to the big¬†manufacturers and to HHS,‚ÄĚ said Sterkel.¬†‚ÄúHe‚Äôs written letters to all of the most-used¬†manufacturers. ‚ÄúWe hope it leads¬†to additional allocations. We‚Äôre trying¬†everything we can.‚ÄĚ

Contact Alana Sterkel, PhD, at 608-224-4277 or Alana.Sterkel@slh.wisc.edu.



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