Zhang, Y Victoria
https://orcid.org/0009-0006-3503-7593
Mayo Clinic
University of Rochester Medicine
Citations 2
Large-Scale Scientific Study Led by a Professional Organization during the COVID-19 Pandemic: Operations, Best Practices, and Lessons Learned
Ondracek, Caitlin R. , Melanson, Stacy E.F. , Doan, Loretta, Schulz, Karen , Kleinman, Stefanie, Zhao, Zhen , Kumánovics, Attila , Wu, Alan H.B. , Wiencek, Joesph R , Meng, Qing H. , Apple, Fred S. , Koch, David D., Vesper, Hubert W. , Pokuah, Fidelia, Bryksin, Janetta, Myers, Gary L., Christenson, Robert H. , Zhang, Y Victoria , Wiencek, Joesph , Ondracek, Caitlin R , Zhang, Y Victoria
The Journal of Applied Laboratory Medicine | December 7, 2023 | Volume: 9 | Issue: 2 | Pages: 371-385
Abstract In 2021, the Association for Diagnostics & Laboratory Medicine (ADLM) (formerly the American Association for Clinical Chemistry [AACC]) developed a scientific study that aimed to contribute to the understanding of SARS-CoV-2 immunity during the evolving course of the pandemic. This study was led by a group of expert member volunteers and resulted in survey data from 975 individuals and blood collection from 698 of those participants. This paper describes the formulation and execution of this large-scale scientific study, encompassing best practices and insights gained throughout the endeavor.
AACC Practical Recommendations for Implementing and Interpreting SARS-CoV-2 Emergency Use Authorization and Laboratory-Developed Test Serologic Testing in Clinical Laboratories
Zhang, Y Victoria , Wiencek, Joesph R , Theel, Elitza S. , Babić, Nikolina , Sepiashvili, Lusia, Pecora, Nicole , Slev, Patricia, Cameron, Andrew , Konforte, Danijela , Wiencek, Joesph , Zhang, Y Victoria, Meng, Qing H.
Clinical Chemistry | March 16, 2021 | Volume: 67 | Issue: 9 | Pages: 1188-1200
Abstract Background The clinical laboratory continues to play a critical role in managing the coronavirus pandemic. Numerous US Food and Drug Administration emergency use authorization (EUA) and laboratory-developed test (LDT) serologic assays have become available. The performance characteristics of these assays and their clinical utility continue to be defined in real time during this pandemic. The AACC convened a panel of experts from clinical chemistry, microbiology, and immunology laboratories; the in vitro diagnostics industry; and regulatory agencies to provide practical recommendations for implementation and interpretation of these serologic tests in clinical laboratories. Content The currently available EUA serologic tests and platforms, information on assay design, antibody classes including neutralizing antibodies, and the humoral immune responses to SARS-CoV-2 are discussed. Verification and validation of EUA and LDT assays are described, along with a quality management approach. Four indications for serologic testing are outlined. Recommendations for result interpretation, reporting comments, and the role of orthogonal testing are also presented. Summary This document aims to provide a comprehensive reference for laboratory professionals and healthcare workers to appropriately implement SARS-CoV-2 serologic assays in the clinical laboratory and to interpret test results during this pandemic. Given the more frequent occurrence of outbreaks associated with either vector-borne or respiratory pathogens, this document will be a useful resource in planning for similar scenarios in the future.