NHC Key Laboratory of AIDS Immunology (China Medical University), National Clinical Research Center for Laboratory Medicine, The First Affiliated Hospital of China Medical University, Shenyang, P.R. China.
Key Laboratory of AIDS Immunology, Chinese Academy of Medical Sciences, Shenyang, P.R. China.
Clin Chem Lab Med. 2021 Sep 17;60(1):92-100. doi: 10.1515/cclm-2021-0736. Print 2022 Jan 26.
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.
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.
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.
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.
外周血淋巴细胞亚群是监测免疫状态的重要参数；然而，淋巴细胞亚群检测既耗时又容易出错。本研究旨在探索一种高效且在临床上有用的自动验证系统，用于流式细胞仪平台上的淋巴细胞亚群检测。
共收集了 94402 例淋巴细胞亚群检测结果。为了建立有限范围规则，首先使用了 80427 例结果（69135 例 T 淋巴细胞亚群检测和 11292 例 NK、B、T 淋巴细胞检测），其中 15000 例来自人类免疫缺陷病毒（HIV）感染患者的 T 淋巴细胞亚群检测用于为 HIV 感染患者设置定制的有限范围规则。随后，使用 13975 例结果进行历史数据验证和在线测试验证。
建立了三个关键的自动验证规则，包括有限范围、差值检查和逻辑规则。总结了解决触发这些规则的问题的指南。验证阶段的历史数据显示，淋巴细胞亚群检测的总自动验证通过率为 69.65%（6941/9966），T 淋巴细胞亚群检测的通过率为 67.93%（5268/7755），NK、B、T 淋巴细胞检测的通过率为 75.67%（1673/2211）。对于在线测试验证，总自动验证通过率为 75.26%（3017/4009），T 淋巴细胞亚群检测的通过率为 73.23%（2191/2992），NK、B、T 淋巴细胞检测的通过率为 81.22%（826/1017）。使用自动验证系统将周转时间（TAT）从 228 分钟缩短至 167 分钟。
基于实验室信息系统的淋巴细胞亚群检测自动验证系统减少了 TAT 和错误报告数量，并有助于识别异常细胞群体，为临床干预提供线索。
