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.
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—such as specimen-collection swabs and viral transport media—were 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. “This information has allowed WSLH to facilitate trades between labs to optimize the limited resources we have available,” 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.
“Having 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,” added Sterkel. “As a subject matter expert in lab testing, I’ve been embedded in the state’s Emergency Operations Center (SEOC) and so have been in contact with the White House and federal agencies such as the Federal Emergency Management Agency,” 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.
“We 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,” she said. “In a weekly report to WCLN member labs, we summarize lab surveillance data based on what the clinical labs report to us.”
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
“Those declining rates in Wisconsin came as a result of efforts to increase testing, institute stay-at-home orders, and conduct contact tracing,” she said. “Until recently, we’ve seen a drop in the number of COVID-19 tests. But, along with the spike in new cases we see testing increase again,” noted Sterkel.
“For 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. “Also, we had a seven-day average of 7.7% positive results on Aug. 19,” she reported. “At the moment, our rate of positive results is concerning.”
“On the state Department of Health Services webpage, you can see that COVID-19 cases have risen and fallen in fits and starts,” Sterkel observed. “There is an interesting correlation between the rise in cases and how mobile Wisconsin residents are. A big part of how we’ve controlled the disease has been a combination of all public health efforts, and testing is a key part of the whole strategy.”
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. “We can see—and the public can see as well—which instruments those labs are using and which they plan to use in the future if they had the supplies they need,” she commented. “Currently, 83 labs are actively testing, and 27 more plan to bring up testing, except they don’t have enough supplies,” Sterkel reported. As of Aug. 19, the network-member labs had the capacity to run 27,211 molecular COVID-19 tests per day.
“From that data, the clinical laboratories can report when they’re experiencing shortages if they’re not getting certain kinds of supplies,” said Sterkel. “We can use that data to advocate on their behalf to get them the quantities of supplies they need to increase testing capacity.
“Most laboratories in Wisconsin are using the Cepheid GeneXpert system,” Sterkel added. “Many more labs would like to use the Cepheid test, but the supplies have been slow to come to Wisconsin,” she warned. “This is an area the SEOC is focusing on so that we can increase supply allocations for the clinical laboratories that need them.
“The 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,” she commented. “Based 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.
“Just seeing those needs allows us to monitor in real time when a lab is no longer able to test because they’ve run out of supplies,” she said. “Even in my lab, we had a very limited supply of extraction reagents early on,” she noted. “Also, 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,” Sterkel reported.
The collaborative approach has worked well during the pandemic. “We have been building up testing in the clinical labs and in some commercial labs as well,” she noted. “The 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.”
For COVID-19 tests that must be sent out, slower-than-usual turnaround times at national reference labs have frustrated Wisconsin’s pathologists and clinical lab directors. “It’s a constant problem for clinical laboratories in our state,” Sterkel said of the limited supplies and kits. “We’ve 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.
“The result is that our clinical labs have taken on diverse strategies by doing testing on multiple different platforms,” she reported. “Here at the state laboratory, we’ve 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.
“Other lab facilities are trying to take that same approach,” she said. “If they don’t 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.
“But with some of the national reference labs, it can take seven to 10 days to get a result back, at least in the beginning,” she added. “Fortunately, that turnaround time seems a bit better now, but it’s still three to four days for a large out-of-state reference lab.”
Among Sterkel’s concerns about the near future is how Wisconsin’s labs will respond when pressed to increase COVID-19 testing when schools reopen and during the flu season this fall. “It’s inevitable that the influenza will come back this fall. What’s that going to look like?” she asked. “And how will we manage our COVID testing when people are symptomatic for COVID and other respiratory viruses?
“Here at the state laboratory, we’re working to bring on combined multiplex testing that can test for COVID and the flu at the same time,” she reported. “We’re also working with our clinical labs to help them develop strategies for how they’re going to manage these patients as well as the increased volume that we expect in the fall.”
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. “That could be a useful test,” 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’s Rapid SARS-CoV-2 test on the company’s GeneXpert systems. “That test is really fast in that it delivers a result in about 40 minutes, and it’s trusted and accurate,” Sterkel commented.
Demand for Lab Instruments
“It’s available widely because Cepheid machines were already placed in many labs around the state, meaning it’s a great way to get testing done everywhere,” 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. “We had to get in line behind 200 other labs that put in orders for these instruments,” she noted. “That shows there’s definitely a demand for the instrumentation associated with COVID testing.”
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.
“The BioFire test is a fairly fast, one-hour assay that’s 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’t test until they get the assay,” Sterkel said.
“Wisconsin received some BioFire supplies, but 17 labs are still waiting to get these supplies,” she said. “So, there’s definitely a gap for getting the supplies where they’re needed.”
The Cepheid GeneXpert is another example of a test for which supplies often run short. “Although we have 52 labs running that test now, some labs have had to stop testing because they haven’t received enough of those tests to keep up with the demand,” she said.
Supply Chain Challenges
“Even labs that have received some testing cartridges have stopped getting the supplies they need, and so they’ve stopped testing,” explained Sterkel. “It’s 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’s fast and reliable. Another test may take longer and not have the same result profile.”
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 “active test methods statewide” 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.
“From the first days, supplies ran short and we had limited shipments coming from our normal commercial sources,” said Alana Sterkel, PhD, D (ABMM), SM (ASCP) CM, Assistant Director in the Communicable Disease Division of the Wisconsin State Laboratory of Hygiene. “So, we worked out a relationship with two local businesses in Wisconsin that make specimen collection kits—although not necessarily kits for COVID-19 testing,” she recalled.
“We asked them to switch over to producing collection kits for COVID-19 testing and we helped them get up and running. “One of our local companies— Gentueri—could source FDA-approved swabs from China,” she said. “This was essential to the success of this endeavor.”
“The 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,” she said. “We then partnered with the state’s Emergency Operations Center to get the supplies out to where they were needed most.”
The second way to improve the supply chain was to ask Evers to intervene. “The governor has worked with us to send letters about our requests to the big manufacturers and to HHS,” said Sterkel. “He’s written letters to all of the most-used manufacturers. “We hope it leads to additional allocations. We’re trying everything we can.”
Contact Alana Sterkel, PhD, at 608-224-4277 or Alana.Sterkel@slh.wisc.edu.