Achieving High Confidence Levels in the Quality and Accuracy of Your Clinical Lab’s Chosen COVID-19 Serology Tests, featuring James Westgard, PhD
Dark Daily and COVID-19 STAT Intelligence Briefings is offering this FREE webinar as a service to our clinical lab and pathology colleagues
Thursday, June 11 at 1:00 PM EDT
As medical labs across the nation validate new, untried COVID-19 serology tests that often incorporate new methodologies, correct use of Westgard Rules & more can ensure an accurate, quality COVID-19 testing program
Now that your clinical laboratory has decided on which COVID-19 serology test it will buy and offer to physicians, patients, and employers with wellness screening programs, your lab team must succeed with the challenging process of validation. This is required—not just for your lab to meet CLIA requirements—but for your lab team to have high confidence that the COVID-19 serology test results are accurate, reproducible, and appropriate for use in patient care.
Adding an unwelcome element to your lab’s validation process is the fact that all new COVID-19 serology tests have an emergency use authorization (EUA) from the federal Food and Drug Administration (FDA). They are new assays and present two unique problems for clinical labs that want to buy and use these tests in patient care.
COVID-19 Serology Tests Have Two Unwelcome Elements for Clinical Labs
First, there are already about 20 of these COVID-19 serology tests that obtained an EUA and many of them use new diagnostic technologies for a serological test. This can present labs with unique challenges during both validation and daily testing activities. After all, antibody testing is already a complex area of clinical diagnostics, so use of serology tests that incorporate new methodologies can present unexpected complications as clinical labs do their required validation of the assay, then put that assay into daily production.
Second, because of the pressure from government officials, the news media, and the public, to get large volumes of COVID-19 serology tests into the market as quickly as possible, the FDA set a low bar on the requirements that manufacturers must meet to obtain an EUA. Therefore, the performance data and specifications published with for each COVID-19 serology test’s EUA is quite limited. Working with such limited, but essential data from the manufacturer increases the challenges—and the risks—for a lab as it validates that assay and the analyzers that will perform the tests, then puts the test into daily production.
CLIA-certified complex clinical laboratories already know the basics for test validation, along with the methods of quality control, proficiency testing, quality assurance, and related activities that help ensure accuracy, reproducibility, and reliability. But COVID-19 serology testing puts a new twist on these long-established processes while putting the lab at risk in new ways, for the reasons mentioned above.
Insights on Serology Test Quality from James O. Westgard and Sten Westgard
That is why we’ve arranged this exclusive webinar to help you and your lab team understand the distinct differences that a COVID-19 serology test is going to throw at your lab. Who better to help you understand these new challenges but James O. Westgard, PhD, FACB, and Sten Westgard, the principals of Westgard QC. Their Westgard Rules have been a linchpin in your clinical laboratory’s quality program for almost four decades.
Participation of you and your lab team in this webinar is free, as a public service to the clinical laboratory profession by The Dark Report, Dark Daily, and our new COVID-19 STAT Intelligence Briefing service during the SARS-CoV-2 pandemic.
The Westgards will discuss how your lab will want to consider COVID-19 testing as a single system. A COVID-19 rapid molecular test may be the first test for a patient, but then your lab will probably get COVID-19 serology test orders for that same patient in successive weeks and months. This means that two different COVID-19 tests done on the same patient at two different times will be measuring two different factors because of the time gap.
Technical goals for the webinar will touch on these essential elements of validation and quality, but applied to the unprecedented challenges labs will face as they work with a new COVID-19 serology test that had limited data on its EUA.
Key insights to be shared include:
- Apply best practices for evaluation of qualitative tests
- Confirm assay accuracy from the clinical agreement study
- Verify claims for sensitivity and specificity with confidence (limits)
- Characterize precision or uncertainty of classification from limit of detection and/or cutoff interval
- Utilize positivity rate to estimate limit of detection or cutoff interval
- Build a COVID19 reflex strategy—repeating positive tests to optimize correctness in surveillance
COVID-19 serology testing can be a game changer for your lab in two critical ways: The upside is that, with elected officials calling for tens of millions of serology tests to manage the pandemic, COVID-19 serology testing can be an important source of revenue, helping to offset the cash crunch cause by the pandemic. The potential downside is that when your lab validates its choice of a COVID-19 serology test, puts it into daily production—and test results prove to be inaccurate or unreliable due to issues with the assay itself and the variability in different batches of reagents and kits.
These are powerful motivators for you and your lab team to join us as James Westgard and Sten Westgard share essential insights and recommendations on the validation and daily production steps your lab should use with its choice of a COVID-19 serology test. Prepare your lab with the tools it needs to have high confidence in the quality and accuracy of its COVID-19 serology testing program.
Westgard QC is a small business providing tools, technology and training for laboratory quality management. He is also an Emeritus Professor in the Department of Pathology and Laboratory Medicine at the University of Wisconsin Medical School. He spent many years as Faculty Director of Quality Management Services for the Clinical Laboratories at the University of Wisconsin Hospital and Clinics, still teaches in the Clinical Laboratory Science Program, and is co-director of a capstone program offering a Graduate Certificate in Laboratory Quality Management via the internet.
A native of North Dakota, Dr. Westgard obtained a BA degree in chemistry from Concordia College in Moorhead, Minnesota, and Master’s and Ph.D. degrees in analytical chemistry from the University of Wisconsin-Madison. He began his career at UW as a Clinical Chemist and served in the past as Director of Clinical Chemistry, Associate Director for Laboratory Administration, and Associate Director for Quality.
Dr. Westgard’s early interest was in the development of method evaluation protocols and he served as the first chairman of the Evaluation Protocols Area Committee in CLSI (then known as NCCLS). He published extensively in this area during the 1970s and 1980s, including a monograph on Method Evaluation published by ASCLS. His interest in quality control began in 1976-77 when he was on sabbatical leave at Uppsala University in Sweden where he worked with Professor Carl Henric deVerdier and Drs Torgny Groth and Torsten Aronsson. This work led to the multi-rule control procedure, internationally known as “Westgard Rules.”
His extensive work in quality management is documented by several books, including Cost-Effective Quality Control: Managing the quality and productivity of analytical processes, Basic QC Practices, Basic Method Validation, CLIA Final Rules for Quality Systems; Assuring the Right Quality Right: Good Laboratory Practices for verifying the attainment of the intended quality of test results; and Six Sigma Quality Design and Control: Desirable precision and requisite QC for laboratory measurement procedures.
Director of Client Services and Technology
Westgard QC, Inc.
Sten Westgard is the company jack-of-all trades — if no one else has the time to do it, Sten probably will
Sten has edited and contributed to numerous books on quality, including Basic QC Practices, Basic Method Validation, Basic Quality Management Systems, Six Sigma QC Design and Control, Six Sigma Risk Analysis, CLIA Final Rules, Assuring the Right Quality Right, The Poor Lab’s Guide to the Regulations, and Nothing but the Truth about Quality.
For more than 20 years, Sten has managed the Westgard website as well as the Westgard course portal and blog, creating and administering online training, as well as editing and writing hundreds of reports, essays, and applications on quality control, method validation, Six Sigma and other laboratory management topics.
Sten has also presented at conferences and workshops both in the US and abroad (in Europe, Asia, Africa, South America, and Australia), on topics such as “Westgard Rules”, IQCP, Six Sigma, Risk Management, Method Validation, and Quality Management. He received an Outstanding Speaker award from the AACC for 2008 through 2012, and 2016.
Sten is an adjunct faculty member at the Mayo Clinic School of Health Sciences in Rochester, Minnesota; an adjunct faculty member at the University of Alexandria, Egypt; an adjunct visiting faculty member at Kastruba Medical College of Manipal University, Mangalore, India; and an honorary visiting professor at Jiao Tong University, Shanghai.
James J. Boutrous II
Detroit Managing Member; Board of Directors
James O. Westgard, PhD, FACB
Westgard QC, Inc.
Director of Client Services and Technology
Westgard QC, Inc.