A Consistency Study of Two Systematic Detection of Serum IgG4 Results
Objective IgG4-related disease(IgG4-RD)is a rare fibro-inflammatory disease,which is prone to missed diagnosis or mis-diagnosis due to non-specific clinical manifestations.In this study, we aim to evaluate the consistency of IgG4 results of Siemens specific protein analyzer BNⅡ(referred to as Siemens) and Beckman specific protein analyzer Immage800 (referred to as Beckman)to provide accurate test results for the clinical diagnosis and treatment of IgG4-related diseases (IgG4-RD).Methods From April,2019 to April,2022,127 serum samples were collected from patients who underwent serum IgG4 detection at The Affiliated Huai'an No.1 People's Hospital of Nanjing Medical University.Siemens BN-Ⅱ specific protein analyzer (supporting reagent)was used as the reference system,while Beckman Immage800 specific protein analyzer (with a domestic reagent)was used as the evaluation system.127 serum samples were detected respectively.The high concentration result was automatically diluted by Siemens system instruments,and Beckman system was manually diluted.We then compared the consistency of the detection results of the two methods and fit the Deming regression curve.Results Grouped by Siemens results,when the level of IgG4 was between 1.35-2.7g/L,there was no statistical difference between the detection results of the two systems (P=0.27),while the IgG4 results were lower than 1.35g/L,2.7-4.05g/L and greater than 4.05g/L.There were significant differences in the results(P<0.05).Among 127 serum samples,10 of the abnormally high concentration of IgG4 were very different between the two systems.After rejection,Pearson correlation analysis of the remaining 117 serum samples suggested that the two methods of detect IgG4 had a good correlation (r=0.96,P<0.001).The consistency of serum IgG4 detected by the two methods of blend-Altman analysis was good, and the fitting regression curve was:IgG4 (Beckman)=0.8597 × IgG4 (Siemens)+0.1319.Conclusion For the clinical application of Siemens instrument (supporting reagent)and Beckman instrument (with a domestic reagent)to detect serum IgG4,the consistency of the two instruments is relatively good for the result of ≤4.05g/L.However, when the serum IgG4 level is greater than 12.0g/L,due to the backband phenomenon and other factors,the use of a domestic reagent could cause false negative results,which is not conducive to the dynamic evaluation of the disease and needs special attentions.
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