Quality Issues Your Clinical Laboratory Should Know Before You Buy or Select COVID-19 Serology Tests
Dark Daily and COVID-19 STAT Intelligence Briefings is offering this FREE webinar as a service to our clinical lab and pathology colleagues
Held Thursday, May 21
Serology Testing of COVID-19 brings new risks for clinical labs because not all COVID-19 tests will produce accurate, reproducible test results—the challenge is to identify and purchase only the best-performing test kits
Coming soon to your clinical laboratory— a tidal wave of orders for COVID-19 serology tests. That’s because elected officials and healthcare policymakers are calling for tens of millions of Americans to be tested in the coming weeks and months. This will be the single largest medical laboratory testing program ever undertaken in the U.S.
The good news? Clinical labs can expect to be paid adequate reimbursement for these huge numbers of COVID-19 antibody tests. That added cash flow is badly needed at the moment and will help keep many labs financially solvent.
Flood of Different COVID-19 Serology Tests Bad News for Clinical Labs
But there is also bad news associated with the expected flood of COVID-19 serology test orders. Soon, as many as 200 vendors will be selling their proprietary COVID-19 antibody test to labs like yours. As of today, more than 160 unique COVID-19 serology tests are available in the market. Yet only eight COVID-19 serology tests have an emergency use authorization (EUA) from the Food and Drug Administration (FDA).
Another reason the coming wave of COVID-19 serology tests can prove to be unwelcome news for labs is that a substantial number of these tests will be poor quality and expected to generate false positive and false negative results at an unacceptable rate. That puts every clinical lab at risk of reporting inaccurate or false results, with dire consequences: unhappy physicians, patients possibly harmed because their COVID-19 test result was wrong, and in extreme cases—malpractice lawsuits.
Judging Quality, Reliability and Accuracy of COVID-19 Serology Tests
Unfortunately, the clinical laboratory industry does not have a Consumers Reports or a “Good Housekeeping Seal of Approval” to independently review the accuracy, reliability, and clinical quality of COVID-19 serology tests. Your lab is on its own when evaluating the test kits now flooding the market.
This is a high-stakes decision for your lab. Pick the wrong COVID-19 serology test and your team will struggle with confidence that results are high quality, accurate, and reproducible.
That’s where this webinar can help. What is better than having the originator of the Westgard Rules guide you through the essential steps of evaluating different COVID-19 serology kits—and the associated data offered by the vendor—to weed out bad kits, and identify those with the highest likelihood of producing accurate, reproducible results?
We are providing the opportunity for you to be a savvy buyer. We’ve invited James O. Westgard, PhD, FACB, and Sten Westgard, principals of Westgard QC to conduct this timely webinar for you and your lab team. Participation is free as a public service to the clinical laboratory profession by The Dark Report during the SARS-CoV-2 pandemic.
Learn Before You Buy. Say No to Flawed COVID-19 Serology Test Kits
Before your clinical laboratory goes “all in” by signing a contract to purchase a COVID-19 serology test kit, you’ll want to attend this useful session. Learn and master the right questions to ask any vendor offering a COVID-19 serology test. Get recommendations about specific ways quality control (QC) and proficiency testing (PT) methods can help you learn more about the performance of these serology tests before you sign a contract and your lab sets up and performs COVID-19 serology tests.
As a team, James Westgard and Sten Westgard will address these key points to help your lab team in its evaluation of different serology COVID-19 tests:
- Understand the testing architecture and intended medical use of COVID-19 testing
- Take Inventory of your laboratory resources
- Navigate the wild west of regulatory “approval”: EUA, LDT, non-EUA
- Assess the expected performance of test methods
- Understand the critical performance characteristics for COVID-19 testing
- Place it in Prevalence Context: How will it perform for your intended patients?
- Ascertain the reliability of the manufacturer
- Marshal resources for laboratory validation, verification and evaluation
Probably the single biggest challenge confronting your clinical laboratory is this: Can your lab implement a COVID-19 serology testing program in a reasonable time that is accurate, delivers quality results for your physician clients, and generates significant cash flow to financially sustain your ongoing operations? This webinar will provide you and your lab team with the vital information to help you answer this question with a “yes”!
330 Million Serology Tests? You Want Your Lab to Be Ready
You already know from the daily COVID-19 White House briefings that some advisors are calling for all Americans to get a COVID-19 serology test. Were that to happen, it will require 330 million of these tests. Even half that number is 165 million tests and it will take months, even more than a year, to deliver those tests to American citizens.
These are the reasons why serology testing for COVID-19 is poised to be the biggest diagnostic testing program in the nation’s history. It is also why you and your lab’s key contributors will want register for this webinar. Register Now.
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.