Application effect evaluation of automatic quality control in biochemical and immunological production line

doi:10.3969/j.issn.1673-8640.2026.06.014

Abstract

Abstract:

Objective To evaluate the application effect of automatic quality control mode in the biochemical and immunological production line. Methods The manual and automatic internal quality control（IQC） results were analyzed by collecting 32 biochemical items and 22 immunological items of production line in Shenzhen Hospital of Southern Medical University from 2023 to 2024. The differences in precision，stability，consumption of quality control specimens，review time of the first report and control failure rate were analyzed. Results Among the 108 quality control data，82 showed statistical significance between the 2 quality control modes（P<0.05）. Under the automatic quality control mode，for the 47 items with industry standards，except for the low-value quality control sample of free prostate speeific antigen whose coefficient of variation（CV） exceeded the industry standard requirements，the CV of the 2-level quality control samples for the other items all met the quality requirements. Totally，7 items had a CV of the low-value quality control sample，and 1 item had a CV of the high-value quality control sample higher than that of the manual quality control mode. There were 12 items with periodic changes related to the storage of quality control specimens. The consumption of quality control samples under the automatic quality control mode was at least 31.51% less than that under the manual quality control mode. Under the automatic quality control mode，the review time of the first report was approximately 10.47 min earlier than that under the manual quality control mode. The out-of-control rates of the automatic quality control mode and the manual quality control mode were 0.07% and 0.06%，respectively. Under the manual quality control mode，there was no out-of-control caused by the quality control specimens，while under the automatic quality control mode，the out-of-control caused by the quality control specimens accounted for 35.71% of the total out-of-control. Conclusions The automatic quality control mode of the biochemical and immunological production line can meet the clinical quality control requirements and has advantages in precision improvement，cost saving and efficiency optimization.

Key words: Automatic quality control, Manual quality control, Internal quality control, Biochemical and immunological production line

CLC Number:

R197.323.2

ZHENG Wenbin, HUANG Rong, GUO Weiquan, WANG Siqi, ZHANG Shichang. Application effect evaluation of automatic quality control in biochemical and immunological production line[J]. Laboratory Medicine, 2026, 41(6): 609-614.

Figures/Tables 6

References 11

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项目	生化多项质控品	液体免疫学和蛋白质质控品	免疫分析质控品	肿瘤标志物质控品	甲状腺相关自身抗体质控品
手工质控	9 000	7 000	19 200	1 400	1 400
自动质控	16 000	13 200	26 000	6 000	8 000
预备体积	24 000	16 000	40 000	16 000	16 000

项目	生化多项质控品	液体免疫学和蛋白质质控品	免疫分析质控品	肿瘤标志物质控品	甲状腺相关自身抗体质控品
手工质控	9 000	7 000	19 200	1 400	1 400
自动质控	16 000	13 200	26 000	6 000	8 000
预备体积	24 000	16 000	40 000	16 000	16 000

年份	质控标本原因/次	人员操作原因		设备和试剂原因/次	失控数合计/次	质控总数/次	失控率/%
年份	质控标本原因/次	配制失误/次	上样操作失误/次	设备和试剂原因/次	失控数合计/次	质控总数/次	失控率/%
2024年	10	11	0	7	28	41 526	0.07
2023年	0	3	9	16	28	46 466	0.06

年份	质控标本原因/次	人员操作原因		设备和试剂原因/次	失控数合计/次	质控总数/次	失控率/%
年份	质控标本原因/次	配制失误/次	上样操作失误/次	设备和试剂原因/次	失控数合计/次	质控总数/次	失控率/%
2024年	10	11	0	7	28	41 526	0.07
2023年	0	3	9	16	28	46 466	0.06

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