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%.
目的： 对国产蓝怡AH600糖化血红蛋白分析仪与其他不同检测系统的结果比对分析，以了解不同检测系统的检测结果的可比性，并确立国产蓝怡AH600测定糖化血红蛋白（haemoglobin A1c，HbA1c）诊断糖尿病的最佳切点。 方法： 采用多中心队列研究，选择我国18家医疗机构临床检验部门分别独立收集2022年3至4月在该院就诊的检测样本，并独立完成待评仪器（蓝怡AH600）和参比仪器HbA1c的比对分析。参比仪器包括爱科来、伯乐、东曹及惠中共4种不同品牌的糖化血红蛋白仪。不同检测系统之间结果的相关性采用散点图，计算回归方程；不同检测系统之间结果的一致性分析采用Bland-Altman法。一致性判断原则：（1）当测量差值95%一致性界限（95% limits of agreement，95% LoA）在0.4%HbA1c之内，且测定得分≥80分，比对一致性好；（2）当测量差值95%LoA超出0.4%HbA1c，测定得分≥80分，比对一致性较好；（3）测定得分<80分，比对一致性差。不同检测系统之间结果的差异性采用配对样本T检验或Wilcoxon配对符号秩和检验；糖尿病的最佳切点值采用受试者特征曲线（receiver operating characteristic curve，ROC）分析。 结果： 有16家医院的蓝怡AH600与参比仪器的结果相关系数R2≥0.99；Bland-Altman一致性分析显示，江苏省南京市妇幼保健院（参比仪器：爱科来HA8180）的差值95% LoA为-0.486%~0.325%，测量得分为94.6分（473/500）；西藏自治区藏医院（参比仪器：伯乐Variant Ⅱ）的差值95% LoA为-0.727%~0.612%，测量得分为89.8分；重庆两江新区第一人民医院（参比仪器：惠中MQ-2000PT）的差值95% LoA为-0.231%~0.461%，测量得分为96.6分；安徽省太和县中医院（参比仪器：惠中MQ-2000PT）的差值95% LoA为-0.469%~0.479%，测量得分为91.9分。其余14家医院蓝怡AH600与4种参比仪器品牌比对，差值95%LoA均小于0.4%HbA1c，得分均大于95分。配对样本T检验或Wilcoxon配对符号秩和检验结果显示：蓝怡AH600与湖南中医药大学第一附属医院参比仪器爱科来HA8180比较差异无统计学意义（Z=1.665，P=0.096），两台仪器测量值的差值均值为0.004%。其余所有机构的蓝怡AH600与参比仪器的比对数据比较差异均具有统计学意义（P均<0.001），但需结合Bland-Altman一致性分析结果综合考虑是否在临床可接受范围。采用蓝怡AH600检测985例糖尿病患者和3 423例非糖尿病患者的HbA1c结果进行ROC分析，曲线下面积（area under curve，AUC）为0.877，标准误为0.007，95%置信区间（95%CI）为（0.864，0.891），差异有统计学意义（P<0.001），Youden指数最大值为0.634，对应的HbA1c切点为6.235%，诊断糖尿病的灵敏度和特异度分别为76.2%和87.2%。 结论： 在现有纳入研究的医院和仪器中，江苏省南京市妇幼保健院（参比仪器：爱科来HA8180）、西藏自治区藏医院（参比仪器：伯乐Variant Ⅱ）、重庆两江新区第一人民医院（参比仪器：惠中MQ-2000PT）以及安徽省太和县中医院（参比仪器：惠中MQ-2000PT）这4家医院的蓝怡AH600与参比仪器比对结论为一致性较好；其余14家医院中涉及爱科来、伯乐、东曹及惠中这4种不同品牌参比仪器，蓝怡AH600与其比对一致性好。国产蓝怡AH600检测HbA1c用于诊断糖尿病的最佳切点值是6.235%。.