HbA1c comparison and diagnostic efficacy analysis of multi center different glycosylated hemoglobin detection systems.

Ping LI; Ying WU; Yan Xie; Feng Chen; Shao Qiang Chen; Yun Hao LI; Qing Qing LU; Jing LI; Yong Wei LI; Dong Xu Pei; Ya Jun Chen; Hui Chen; Yan LI; Wei Wang; Hai Wang; He Tao YU; Zhu BA; De Cheng; Le Ping Ning; Chang Liang Luo; Xiao Song Qin; Jin Zhang; Ning WU; Hui Jun Xie; Jina Hua Pan; Jian Shui; Jian Wang; Jun Ping Yang; Xing Hui Liu; Feng Xia XU; Lei Yang; Li Yi HU; Qun Zhang; Biao LI; Qing Lin Liu; Man Zhang; Shou Jun Shen; Min Min Jiang; Yong WU; Jin Wei HU; Shuang Quan Liu; Da Yong GU; Xiao Bing Xie

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HbA1c comparison and diagnostic efficacy analysis of multi center different glycosylated hemoglobin detection systems.

Author: Ping LI ¹ ; Ying WU ² ; Yan XIE ² ; Feng CHEN ¹ ; Shao qiang CHEN ¹ ; Yun Hao LI ¹ ; Qing Qing LU ¹ ; Jing LI ¹ ; Yong Wei LI ³ ; Dong Xu PEI ³ ; Ya Jun CHEN ⁴ ; Hui CHEN ⁵ ; Yan LI ⁶ ; Wei WANG ⁷ ; Hai WANG ⁸ ; He Tao YU ⁸ ; Zhu BA ⁹ ; De CHENG ⁹ ; Le Ping NING ¹⁰ ; Chang Liang LUO ¹⁰ ; Xiao Song QIN ¹¹ ; Jin ZHANG ¹¹ ; Ning WU ¹² ; Hui Jun XIE ¹² ; Jina Hua PAN ¹³ ; Jian SHUI ¹³ ; Jian WANG ¹⁴ ; Jun Ping YANG ¹⁴ ; Xing Hui LIU ¹⁵ ; Feng Xia XU ¹⁵ ; Lei YANG ¹⁶ ; Li Yi HU ¹⁶ ; Qun ZHANG ¹⁷ ; Biao LI ¹⁷ ; Qing Lin LIU ¹⁸ ; Man ZHANG ¹⁸ ; Shou Jun SHEN ¹⁹ ; Min Min JIANG ¹⁹ ; Yong WU ²⁰ ; Jin Wei HU ²⁰ ; Shuang Quan LIU ²¹ ; Da Yong GU ²² ; Xiao Bing XIE ¹
Author Information

1. Department of Medical Laboratory and Pathology Center, the First Affiliated Hospital of Hunan University of Chinese Medicine, Changsha 410007, China.
2. Changsha DIAN Medical Laboratory, Changsha 410000, China.
3. Department of Laboratory Medicine, Henan Province Hospital of Traditional Chinese Medicine, Zhengzhou 450002, China.
4. Department of Medical Laboratory, Nanjing Maternity and Child Health Care Hospital, Nanjing 210004, China.
5. Department of Clinical Laboratory, the Third Xiangya Hospital of Central South University, Changsha 410013, China.
6. Department of Medical Laboratory, the First Affiliated Hospital of Shandong First Medical University, Jinan 250014,China.
7. Department of Laboratory Medicine, Dongguan Chang'an Hospital, Dongguan 523843, China.
8. Department of Laboratory, Tongde Hospital of Zhejiang Province, Hangzhou 310012, China.
9. Clinical Laboratory, Tibetan Hospital of Tibet Atonomous Region, Lhasa 850002, China.
10. Department of Clinical Laboratory, the People's Hospital of Guangxi Zhuang Autonomous Region, Nanning 530021, China.
11. Department of Clinical Laboratory, Shengjing hospital of China Medical University, Shenyang 110004, China.
12. Department of Medical Laboratory, Hengyang First People's Hospital, Hengyang 421002, China.
13. Department of Medical Laboratory, the Affiliated Changsha Central Hospital, Hengyang Medical School, University of South China, Changsha 410004, China.
14. Department of Medical Laboratory, the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Nanchang 330006, China.
15. Department of Clinical Laboratory, Gongli Hospital of Shanghai Pudong New Area, Shanghai 200135, China.
16. Department of Medical Laboratory, the People's Hospital of Chongqing Liang Jiang New Area, Chongqing 401121, China.
17. Department of Medical Laboratory, Taihe Hospital of traditional Chinese Medicine, Taihe County 236600, China.
18. Department of Clinical Laboratory, Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China.
19. Department of Medical Laboratory, the First People's Hospitao of Jiashan County, Zhejiang Province, Jiashan County 314100, China.
20. Department of Clinical Laboratory, the Affiliated Changsha Hospital of Xiangya School of Medicine, Central South University, Changsha 410005, China.
21. Department of Clinical Laboratory Medicine, the First Affiliated Hospital, Hengyang Medical School, University of South China, Hengyang 421002, China.
22. Department of Laboratory Medicine, Shenzhen Second People's Hospital, Shenzhen 518025, China.
Publication Type:Journal Article
MeSH: Pregnancy; Child; Humans; Female; Glycated Hemoglobin; Cohort Studies; Diabetes Mellitus/diagnosis*; Sensitivity and Specificity; ROC Curve
From: Chinese Journal of Preventive Medicine 2023;57(7):1047-1058
CountryChina
Language:Chinese
Abstract: Objective: Compare and analyze the results of the domestic Lanyi AH600 glycated hemoglobin analyzer and other different detection systems to understand the comparability of the detection results of different detectors, and establish the best cut point of Lanyi AH600 determination of haemoglobin A1c (HbA1c) in the diagnosis of diabetes. Methods: Multi center cohort study was adopted. The clinical laboratory departments of 18 medical institutions independently collected test samples from their respective hospitals from March to April 2022, and independently completed comparative analysis of the evaluated instrument (Lanyi AH600) and the reference instrument HbA1c. The reference instruments include four different brands of glycosylated hemoglobin meters, including Arkray, Bio-Rad, DOSOH, and Huizhong. Scatter plot was used to calculate the correlation between the results of different detection systems, and the regression equation was calculated. The consistency analysis between the results of different detection systems was evaluated by Bland Altman method. Consistency judgment principles: (1) When the 95% limits of agreement (95% LoA) of the measurement difference was within 0.4% HbA1c and the measurement score was≥80 points, the comparison consistency was good; (2) When the measurement difference of 95% LoA exceeded 0.4% HbA1c, and the measurement score was≥80 points, the comparison consistency was relatively good; (3) The measurement score was less than 80 points, the comparison consistency was poor. The difference between the results of different detection systems was tested by paired sample T test or Wilcoxon paired sign rank sum test; The best cut-off point of diabetes was analyzed by receiver operating characteristic curve (ROC). Results: The correlation coefficient R² of results between Lanyi AH600 and the reference instrument in 16 hospitals is≥0.99; The Bland Altman consistency analysis showed that the difference of 95% LoA in Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180) was -0.486%-0.325%, and the measurement score was 94.6 points (473/500); The difference of 95% LoA in the Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant II) was -0.727%-0.612%, and the measurement score was 89.8 points; The difference of 95% LoA in the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT) was -0.231%-0.461%, and the measurement score was 96.6 points; The difference of 95% LoA in the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT) was -0.469%-0.479%, and the measurement score was 91.9 points. The other 14 hospitals, Lanyi AH600, were compared with 4 reference instrument brands, the difference of 95% LoA was less than 0.4% HbA1c, and the scores were all greater than 95 points. The results of paired sample T test or Wilcoxon paired sign rank sum test showed that there was no statistically significant difference between Lanyi AH600 and the reference instrument Arkray HA8180 (Z=1.665,P=0.096), with no statistical difference. The mean difference between the measured values of the two instruments was 0.004%. The comparison data of Lanyi AH600 and the reference instrument of all other institutions had significant differences (all P<0.001), however, it was necessary to consider whether it was within the clinical acceptable range in combination with the results of the Bland-Altman consistency analysis. The ROC curve of HbA1c detected by Lanyi AH600 in 985 patients with diabetes and 3 423 patients with non-diabetes was analyzed, the area under curve (AUC) was 0.877, the standard error was 0.007, and the 95% confidence interval 95%CI was (0.864, 0.891), which was statistically significant (P<0.001). The maximum value of Youden index was 0.634, and the corresponding HbA1c cut point was 6.235%. The sensitivity and specificity of diabetes diagnosis were 76.2% and 87.2%, respectively. Conclusion: Among the hospitals and instruments currently included in this study, among these four hospitals included Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180), Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant Ⅱ), the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT), and the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT), the comparison between Lanyi AH600 and the reference instruments showed relatively good consistency, while the other 14 hospitals involved four different brands of reference instruments: Arkray, Bio-Rad, DOSOH, and Huizhong, Lanyi AH600 had good consistency with its comparison. The best cut point of the domestic Lanyi AH600 for detecting HbA1c in the diagnosis of diabetes is 6.235%.