Consistency evaluation of thyroid stimulating hormone results from 4 chemiluminescence assays

Danchen Wang; Songlin YU; Yicong Yin; Xiuzhi Guo; Xinqi Cheng; Ling Qiu; Chaochao MA; Ruili Zhang; Qian Liu; Li Liu; Xuehui Gao; Kui Zhang

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Consistency evaluation of thyroid stimulating hormone results from 4 chemiluminescence assays

VernacularTitle:4种促甲状腺素免疫法检测系统结果的一致性评价
Author: Danchen WANG ^{1
,

2} ; Songlin YU ^{1
,

2} ; Yicong YIN ^{1
,

2} ; Xiuzhi GUO ^{1
,

2} ; Xinqi CHENG ^{1
,

2} ; Ling QIU ^{1
,

2} ; Chaochao MA ^{1
,

2} ; Ruili ZHANG ^{1
,

2} ; Qian LIU ^{1
,

2} ; Li LIU ^{1
,

2} ; Xuehui GAO ^{1
,

2} ; Kui ZHANG ^{1
,

2}
Author Information

1. Department of Laboratory Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Science &
2. Peking Union Medical College
Publication Type:Journal Article
Keywords: thyroid stimulating hormone; methodological comparison; chemiluminescence assay
From: Chinese Journal of Clinical Laboratory Science 2019;37(1):62-66
CountryChina
Language:Chinese
Abstract: Objective:To compare the consistency of thyroid stimulating hormone (TSH) results from four chemiluminescence assays.
Methods:A total of 102 fresh serum samples from Peking Union Medical College Hospital during March 2018 and April 2018 were collected for precision evaluation and methodological comparison referring to CLSI EP15-A2 and EP9-A2 protocols. The levels of serum TSH were detected by Abbott i2000 (system A), Beckman DXI800 (system B), Siemens ADVIA Centaur XP (system C) and Roche e601 (system D) automatic chemiluminescence analyzers and their matching reagents, respectively. The obtained results were compared with the passing-bablok and Bland Altman methods. Taking 0.27 μIU/mL and 5.33 μIU/mL as the medical decision level, the expected bias of each detection system was compared.
Results:The precisions of systems A,B,C and D were 1.7%-3.3%， 2.3%- 3.9%，0.7%-2.3% and 0.6%-1.5%,respectively. The median (P 25,P 75) of TSH concentrations detected by systems A,B,C and D were 1.898 (0.518,4.809)μIU/mL, 2.819 (0.719,7.020)μIU/mL,2.502 (0.692,6.888)μIU/mL and 3.105 (0.886, 7.905)μIU/mL, respectively. The coefficients of determination (R 2 ) of regression equation were above 0.975 for 4 detection systems. The correlation coefficients (r), intercepts and slopes of 4 detection systems were 0.993 5-0.997 1, 0-0.06 and 0.59-1.15, respectively, and systems B and C had the best correlations with 1.02 of slope and 0 of intercept. The deviation plot showed that the bias% of 4 detection systems was between -48.1% and 17.3%. Among them, systems A and D had the largest bias, while systems B and C had the lowest bias. The expected bias of 4 detection systems at the medical decision level was -40.7%-37.2%.
Conclusion:The consistency between Beckman and Siemens TSH detection systems is good, while those of Roche and Abbott TSH detection systems are different from the other two.