运用上海地区室间质评结果评价2种糖化血红蛋白POCT分析仪

doi:10.3969/j.issn.1673-8640.2018.03.014

摘要/Abstract

摘要： 目的了解上海地区临床实验室2种糖化血红蛋白（HbA_1c）即时检验（POCT）分析仪的性能。方法使用来源于医院临床实验室剩余的人全血样本的室间质控品,将2种HbA_1cPOCT分析仪[QUO-Test糖化血红蛋白仪（简称QUO-Test）和NycoCard ReaderⅡ糖化血红蛋白仪（简称NycoCard ReaderⅡ）]（POCT组）检测结果的均值分别与离子交换高压液相法（简称高压液相法）、离子交换低压液相法（简称低压液相法）及免疫比浊法（常规方法组）检测结果的均值进行比对,以均值±7%作为2个组系统偏移的标准;计算POCT组的均值与国际临床化学和检验医学联合会（IFCC）HbA_1c参考方法赋值靶值的偏移,以±6%为正确度的允许偏移的标准,同时计算POCT组的组内变异系数（CV）。结果 2015年POCT组与常规方法组的比对结果优于2014年,POCT组与高压液相法的偏移基本在允许范围内。 2014年的比对结果中,QUO-Test与低压液相法和免疫比浊法的可比性均较差;NycoCard ReaderⅡ与低压液相法存在一定的偏差,与高压液相法和免疫比浊法均有较好的可比性;2014年5个质控样本POCT组与IFCC靶值的偏移均为正偏移,QUO-Test均值与靶值的偏移除浓度为7.7%的样本超出允许范围外,其他4个样本的偏移均在允许范围内;NycoCard ReaderⅡ均值与靶值的偏移均在允许范围内,且整体小于QUO-Test。结论 NycoCard ReaderⅡ与常规方法尤其是高压液相法具有较好的可比性,正确度符合要求,能满足临床检测的需要。

关键词: 糖化血红蛋白, 即时检验分析仪, 正确度

Abstract:

Objective To study the performance of 2 glycated hemoglobin A_1c （HbA_1c）point-of-care testing（POCT）analyzers in Shanghai. Methods External quality assessment samples were collected from remaining whole blood samples of Shanghai clinical laboratories. The mean values of 2 HbA_1c POCT analyzers （QUO-Test and NycoCard ReaderⅡglycated hemoglobin analyzers）（POCT group）were compared with the mean values of ionic exchange high pressure liquid phase method,ionic exchange low pressure liquid phase method and immuno-turbidimetry. The system bias between 2 HbA_1c POCT analyzers（±7%） was used as standard,and the bias of the mean values of the 2 HbA_1c POCT analyzers with the reference value assigned by the International Federation of Clinical Chemistry and Laboratory Medicine （IFCC）reference method was calculated. The allowable bias for trueness was ±6% as standard,and the intra-group coefficient of variation （CV）of the 2 HbA_1c POCT analyzers was calculated. Results For POCT group,the results of 2 HbA_1c POCT analyzers compared to the 3 conventional determination methods in 2015 were better than those in 2014. The bias of POCT group compared with high pressure liquid phase method was within allowable range. In 2014,the biases of QUO-Test with low pressure liquid phase method and immuno-turbidimetry were not good. The biases of NycoCard ReaderⅡ in 2014 were in good agreement with high pressure liquid phase method and immuno-turbidimetry,except low pressure liquid phase method. In 2004,for 5 quality control samples,the bias between POCT group and IFCC target value was positive bias. The bias between the mean value of QUO-Test and the target value was within the acceptable bias range except for a level of 7.7%. The bias between the mean value of NycoCard ReaderⅡ and the target value was within the acceptable bias range,which was less than that of QUO-Test. Conclusions NycoCard ReaderⅡ with conventional determination methods,especially high pressure liquid phase method has good comparability. The trueness is compliance with requirement,which can meet the needs of clinical determination.

Key words: Glycated hemoglobin A_1c, Point-of-care testing analyzer, Trueness

中图分类号:

R446.1

唐立萍, 欧元祝, 刘文彬, 虞啸炫. 运用上海地区室间质评结果评价2种糖化血红蛋白POCT分析仪[J]. 检验医学, 2018, 33(3): 248-251.

TANG Liping, OU Yuanzhu, LIU Wenbin, YU Xiaoxuan. Evaluation of 2 HbA_1c POCT analyzers based on the results of external quality assessment in Shanghai[J]. Laboratory Medicine, 2018, 33(3): 248-251.

图/表 5

参考文献 8

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样本编号	QUO-Test（23家）	高压液相法（233家）		低压液相法（25家）		免疫比浊法（22家）
样本编号	均值	均值	偏移	均值	偏移	均值	偏移
1	8.8	8.4	4.8	7.9	11.4	8.2	7.3
2	5.8	5.6	5.5	5.1	13.7	5.6	3.6
3	10.8	10.5	2.9	10.1	6.9	10.4	3.8
4	7.5	7.3	2.7	6.9	8.7	7.2	4.2
5	8.3	7.9	5.1	7.6	9.2	7.7	7.8

样本编号	QUO-Test（23家）	高压液相法（233家）		低压液相法（25家）		免疫比浊法（22家）
样本编号	均值	均值	偏移	均值	偏移	均值	偏移
1	8.8	8.4	4.8	7.9	11.4	8.2	7.3
2	5.8	5.6	5.5	5.1	13.7	5.6	3.6
3	10.8	10.5	2.9	10.1	6.9	10.4	3.8
4	7.5	7.3	2.7	6.9	8.7	7.2	4.2
5	8.3	7.9	5.1	7.6	9.2	7.7	7.8

样本编号	NycoCard ReaderⅡ（4家）	高压液相法（233家）		低压液相法（25家）		免疫比浊法（22家）
样本编号	均值	均值	偏移	均值	偏移	均值	偏移
1	8.5	8.4	1.2	7.9	7.6	8.2	3.7
2	5.7	5.6	1.8	5.1	11.8	5.6	1.8
3	10.6	10.5	1.0	10.1	5.0	10.4	1.9
4	7.4	7.3	1.4	6.9	7.2	7.2	2.8
5	8.0	7.9	1.3	7.6	5.3	7.7	3.9

样本编号	NycoCard ReaderⅡ（4家）	高压液相法（233家）		低压液相法（25家）		免疫比浊法（22家）
样本编号	均值	均值	偏移	均值	偏移	均值	偏移
1	8.5	8.4	1.2	7.9	7.6	8.2	3.7
2	5.7	5.6	1.8	5.1	11.8	5.6	1.8
3	10.6	10.5	1.0	10.1	5.0	10.4	1.9
4	7.4	7.3	1.4	6.9	7.2	7.2	2.8
5	8.0	7.9	1.3	7.6	5.3	7.7	3.9

样本编号	QUO-Test（12家）	高压液相法（256家）		低压液相法（17家）		免疫比浊法（24家）
样本编号	均值	均值	偏移	均值	偏移	均值	偏移
1	6.2	5.7	8.8	5.6	10.7	5.7	8.8
2	6.7	6.3	6.4	6.3	6.4	6.4	4.7
3	7.3	6.8	7.4	6.9	5.8	6.9	5.8
4	8.0	7.6	5.3	7.7	3.9	7.6	5.3
5	9.8	9.4	4.3	9.4	4.3	9.4	4.3