Preliminary study on an improved method for constructing internal quality control framework of ELISA
10.13303/j.cjbt.issn.1004-549x.2026.01.015
- VernacularTitle:ELISA试验室内质控框架构建方法改进初探
- Author:
Youbin DUAN
1
;
Rui WANG
2
;
Le CHANG
3
;
Changwen QIU
4
;
Zhiqiang LI
5
;
Gengrui CHEN
6
;
Jingjuan YANG
7
;
Qing HE
1
;
Lunan WANG
3
Author Information
1. Yunnan Kunming Blood Center, Kunming 650106, China
2. Beijing Red Cross Blood Center, Beijing 100088, China
3. National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology, Beijing 100730, China
4. Nanning Central Blood Station, Nanning 530007, China
5. Honghe Central Blood Station, Mengzi 661100, China
6. Dali Central Blood Station, Dali 671000, China
7. Baoshan Central Blood Station, Baoshan 678000, China
- Publication Type:Journal Article
- Keywords:
ELISA;
internal quality control;
quality control framework;
blood station laboratory
- From:
Chinese Journal of Blood Transfusion
2026;39(1):103-108
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To propose an improved method for constructing the internal quality control (IQC) framework for ELISA assays and validate its efficacy by statistically analyzing IQC data from nine blood center laboratories. Methods: 1) IQC data was collected from nine blood centers and analyzed using a domestic HBsAg ELISA detection kit as an example. 2) Differences between IQC values across batches within Blood Center 1 were assessed. 3) Statistical analyses were performed on batch usage, number of batches used, days of use, number of QC points, batch-specific means, and coefficients of variation (CV) across all nine centers. 4) Using the improved construction method for IQC framework, provisional and permanent frames were established for batches within Blood Center 1 and Blood Center 9, followed by outlier determination. Results: 1) Statistically significant differences were observed in IQC data between batches within Blood Center 1 (P<0.01). It is recommended that both the control material/reagents and the control chart framework be replaced simultaneously. 2) There were substantial differences among 9 blood centers regarding the control material/reagent lot numbers used, the number of QC runs per batch, and the QC values for identical lots. Therefore, individual laboratories should establish their own IQC chart frameworks. 3) The improved IQC framework construction method for ELISA assays is as follows: provisional frames are established via frame-shifting, using the pre-experimental mean and cumulative coefficient of variation (CV) from the preceding batch. For batches used >20 days with >20 QC points, permanent frames are constructed by aggregating in-control data accumulated over ≥20 days with ≥20 points to calculate cumulative mean and standard deviation. The provisional and permanent frames constructed by this method identified all 26 extreme outliers across Blood Centers 1 and 9 as out-of-control. Among the 218 general outliers, 10 were classified as normal by the provisional frames, while the remainder were designated as warnings or out-of-control. This method effectively monitors assay stability. Conclusion: Based on the statistical analysis of IQC practices across blood centers of varying scales, combined with the inherent characteristics of ELISA assays and the batch-to-batch instability of reagents/QC materials, it is recommended to reconstruct QC charts upon lot changes. The proposed method—utilizing frame-shifting for provisional frames and establishing permanent frames based on cumulative data—is applicable to blood center laboratories of differing sizes and effectively monitors the stability of the ELISA assay process.
