电化学发光技术检测血清25羟基维生素D的性能验证及分析
|
摘要
为了探究血清25羟基维生素D试剂盒在本实验室电化学发光技术下能否达到厂家声明的分析性能指标,对长期在南充地区居住的健康体检者20例受试人,采用对照美国临床实验室标准化协会(CLSI) EP15-A3/EP9-A3文件《临床化学设备线性评价指南》以及《临床实验室检验项目参考区间的制定》,并根据试剂说明书验证血清25羟基维生素D试剂盒的的精密度、正确度、线性范围、参考区间,通过回归拟合及相关分析,得到精密度验证的低值和高值质控品的批内精密度、批间精密度.结果显示:在20例样品检测中,发现仅1例低于国内专家推荐的参考区间≤20 ng/mL.因此,血清25羟基维生素D试剂盒在本实验室能达到厂家声明的分析性能指标,符合临床检测要求.
In order to investigate whether the serum 25 hydroxyvitamin D kit can meet the analytical performance indexes declared by the manufacturer under the electrochemiluminescence technique in this laboratory, 20 persons who have been living in Nanchong area for a long time were studied. Compared with the American Association for Standardization of Clinical Laboratories(CLSI) EP15-A3, EP9-A3), The Guidelines for Linear Evaluation of Clinical Chemical Equipment and The Reference Interval for Clinical Laboratory Testing Items were used. The precision, accuracy, linear range and reference interval of the serum 25 hydroxyvitamin D kit were verified according to the reagent specification. By regression fitting and correlation analysis, the precision of the low value and high value quality control products and the precision between batches were obtained. The results show that in20 samples, only one case was found to be lower than the reference range recommended by domestic experts. Therefore, the serum~25-hydroxyvitamin D kit can meet the manufacturers stated analytical performance index in this laboratory and meet the requirements of clinical detection.
In order to investigate whether the serum 25 hydroxyvitamin D kit can meet the analytical performance indexes declared by the manufacturer under the electrochemiluminescence technique in this laboratory, 20 persons who have been living in Nanchong area for a long time were studied. Compared with the American Association for Standardization of Clinical Laboratories(CLSI) EP15-A3, EP9-A3), The Guidelines for Linear Evaluation of Clinical Chemical Equipment and The Reference Interval for Clinical Laboratory Testing Items were used. The precision, accuracy, linear range and reference interval of the serum 25 hydroxyvitamin D kit were verified according to the reagent specification. By regression fitting and correlation analysis, the precision of the low value and high value quality control products and the precision between batches were obtained. The results show that in20 samples, only one case was found to be lower than the reference range recommended by domestic experts. Therefore, the serum~25-hydroxyvitamin D kit can meet the manufacturers stated analytical performance index in this laboratory and meet the requirements of clinical detection.
引文
[1] ROSEN C J. Clinical practice:vitamin D insufficiency[J]. N Engl J Med, 2011, 364(14):248-254.
[2] HOLICK M F. Vitamin D deficiency[J]. N Engl J Med, 2007,357(3):266-281.
[3] HOLLIS B W, BIKLE D D. Vitamin D-binding protein and vitamin D in blacks and whites[J]. N Engl J Med, 2014,370(9):879-880.
[4]赵蓓蓓,陈雅婷,董衡,等.25羟基维生素D检测方法的可靠性分析[J].临床儿科杂志,2017,35(12):957-960.
[5]周琰,潘柏申.维生素D检测标准化进程[J].检验医学,2016(1):71-75.
[6] ZERWEKH J E. Blood biomarkers of vitamin D status[J].Am J Clin Nutr, 2008, 87(4):1087-1091.
[7] LEINO A, TURPEINEN U, KOSKINEN P. Automated measurent of 25-OH vitamin D3on the Roche modular E170 analyzer[J]. Clin Chem, 2008,54(12):2059-2062.
[8]熊遹,钱士匀,熊小泉,等.海南地区成人血清25羟基-维生素D参考区间的初步调查[J].检验医学,2014,29(5):464-467.
[9]陈德才,廖二元,徐苓,等.骨代谢生化标志物临床应用指南[J].中华骨质疏松和骨矿盐疾病杂志, 2015,8(4):283-293.
[10]禹松林,方慧玲,程歆琦,等.五种自动化免疫学方法和液相色谱串联质谱方法测定25羟维生素D的比较[J].中华检验医学杂志,2015,38(7):475-479.
[2] HOLICK M F. Vitamin D deficiency[J]. N Engl J Med, 2007,357(3):266-281.
[3] HOLLIS B W, BIKLE D D. Vitamin D-binding protein and vitamin D in blacks and whites[J]. N Engl J Med, 2014,370(9):879-880.
[4]赵蓓蓓,陈雅婷,董衡,等.25羟基维生素D检测方法的可靠性分析[J].临床儿科杂志,2017,35(12):957-960.
[5]周琰,潘柏申.维生素D检测标准化进程[J].检验医学,2016(1):71-75.
[6] ZERWEKH J E. Blood biomarkers of vitamin D status[J].Am J Clin Nutr, 2008, 87(4):1087-1091.
[7] LEINO A, TURPEINEN U, KOSKINEN P. Automated measurent of 25-OH vitamin D3on the Roche modular E170 analyzer[J]. Clin Chem, 2008,54(12):2059-2062.
[8]熊遹,钱士匀,熊小泉,等.海南地区成人血清25羟基-维生素D参考区间的初步调查[J].检验医学,2014,29(5):464-467.
[9]陈德才,廖二元,徐苓,等.骨代谢生化标志物临床应用指南[J].中华骨质疏松和骨矿盐疾病杂志, 2015,8(4):283-293.
[10]禹松林,方慧玲,程歆琦,等.五种自动化免疫学方法和液相色谱串联质谱方法测定25羟维生素D的比较[J].中华检验医学杂志,2015,38(7):475-479.