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Licensed Unlicensed Requires Authentication Published by De Gruyter September 17, 2021

The development of autoverification system of lymphocyte subset assays on the flow cytometry platform

Jue Shi, Run-Qing Mu, Pan Wang, Wen-Qing Geng, Yong-Jun Jiang, Min Zhao, Hong Shang and Zi-Ning Zhang

Abstract

Objectives

Peripheral blood lymphocyte subsets are important parameters for monitoring immune status; however, lymphocyte subset detection is time-consuming and error-prone. This study aimed to explore a highly efficient and clinically useful autoverification system for lymphocyte subset assays performed on the flow cytometry platform.

Methods

A total of 94,402 lymphocyte subset test results were collected. To establish the limited-range rules, 80,427 results were first used (69,135 T lymphocyte subset tests and 11,292 NK, B, T lymphocyte tests), of which 15,000 T lymphocyte subset tests from human immunodeficiency virus (HIV) infected patients were used to set customized limited-range rules for HIV infected patients. Subsequently, 13,975 results were used for historical data validation and online test validation.

Results

Three key autoverification rules were established, including limited-range, delta-check, and logical rules. Guidelines for addressing the issues that trigger these rules were summarized. The historical data during the validation phase showed that the total autoverification passing rate of lymphocyte subset assays was 69.65% (6,941/9,966), with a 67.93% (5,268/7,755) passing rate for T lymphocyte subset tests and 75.67% (1,673/2,211) for NK, B, T lymphocyte tests. For online test validation, the total autoverification passing rate was 75.26% (3,017/4,009), with 73.23% (2,191/2,992) for the T lymphocyte subset test and 81.22% (826/1,017) for the NK, B, T lymphocyte test. The turnaround time (TAT) was reduced from 228 to 167 min using the autoverification system.

Conclusions

The autoverification system based on the laboratory information system for lymphocyte subset assays reduced TAT and the number of error reports and helped in the identification of abnormal cell populations that may offer clues for clinical interventions.


Corresponding authors: Hong Shang, MD, PhD, NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, No 155, Nanjing North Street, Heping District, Shenyang, Liaoning Province, 110001, P.R. China; Key Laboratory of AIDS Immunology, Chinese Academy of Medical Sciences, Shenyang, P.R. China; and Department of Clinical Laboratory, The First Affiliated Hospital of China Medical University, Shenyang, P.R. China, Phone: +86 (24) 8328 2634, Fax: +86 (24) 8328 2634, E-mail: ; and Zi-Ning Zhang, MD, PhD, NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, No 155, Nanjing North Street, Heping District, Shenyang, Liaoning Province, 110001, P.R. China; and Key Laboratory of AIDS Immunology, Chinese Academy of Medical Sciences, Shenyang, P.R. China, Phone: +86 (24) 8328 2634, Fax: +86 (24) 8328 2634, E-mail:
Jue Shi, Run-Qing Mu and Pan Wang contributed equally to this work.

Acknowledgments

This research was supported by the Social Development Program from Shenyang Science and Technology Bureau, China (Grant No. 20-205-4-005).

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

  3. Informed consent: Not applicable.

  4. Ethical approval: Ethics approval was obtained from the Ethics Committee of the First Affiliated Hospital of China Medical University (2021 No. 247).

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Received: 2021-06-24
Accepted: 2021-09-04
Published Online: 2021-09-17
Published in Print: 2022-01-26

© 2021 Walter de Gruyter GmbH, Berlin/Boston

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