Evaluating the measurement uncertainty of human immune serum IgG antibody content against type 1 pneumococcal capsular polysaccharide using ELISA by control charting techniques
10.13200/j.cnki.cjb.004694
- VernacularTitle:控制图法评定ELISA法检测人免疫血清1型肺炎球菌抗荚膜多糖IgG抗体含量的测量不确定度
- Author:
Bin LI
- Publication Type:Journal Article
- Keywords:
Uncertainty;
Control charting techniques;
Pneumococcal vaccine;
Human immune serum;
IgG antibody
- From:
Chinese Journal of Biologicals
2026;39(05):566-571
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the measurement uncertainty of human immune serum IgG antibody content against type1 pneumococcal capsular polysaccharide detecting by ELISA through control charting techniques, so as to establish a method for monitoring the performance of laboratory measurement system and evaluating the detection ability.MethodsAccording to GB/T 27411-2012“Routine methods for evaluation and expression of measurement uncertainty in testing laboratory”, GB/T 27407-2010“Quality control in laboratories——Applying statistical quality assurance and control charting techniques to evaluate analytical measurement system performance” and GB/T 27420-2018“Conformity assessment——Application guide for evaluation and expression of uncertainty in biological sample measurement”, the measurement uncertainty of type 1 IgG antibody detection results in quality control serum 09 CS by ELISA was assessed under intermediate precision conditions using the control charting techniques.ResultsThe quality control data conformed to the assumptions of normality and independence. The bias of the measurement process was negligible. The overlay plot of measured values and exponentially weighted moving average(EWMA), along with the moving range(MR) chart, indicated that both the measurement system shift and the measurement process were under control. The measurement uncertainty(u) of IgG antibody content was equivalent to the intermediate precision(s_(R')), with the type 1 IgG antibody detection result reported as(18. 53 ± 2. 16) ??g/mL, k = 2.ConclusionThe control charting techniques, combined with quality control serum testing results, can be used to evaluate the measurement uncertainty of IgG antibody content against pneumococcal capsular polysaccharide in human immune serum in laboratory settings.
