输血相容性试验室内质控品的研制
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摘要
目的研制出简易可行,可在一般实验室使用的质控品。方法选择10人份健康献血者的浓缩红细胞(O/AB型RhD阳性)制备红细胞质控品,取新鲜血浆(O/AB型RhD阳性)和抗-D(IgG)人血清配制血浆质控品。对制备好的质控品进行性能评价,包括重复性、稳定性、最佳条件与常规条件下测定比较以及微柱凝胶法与凝聚胺法测定比较。结果质控品的批内重复性CV均<10%,批间重复性差异无统计学意义(P>0.05)。在不同保存时间,条件及方法的条件下,质控品检测结果均无明显变化(P>0.05)。统计分析6个月的室内质控结果,在控率为100%。结论成功研制出输血相容性试验室内质控品,该质控品具有较好的重复性,稳定性及实用性。
Objective The aim of this study was to prepare a series of internal quality control( IQC) products for blood transfusion compatibility tests,which should be easy-to-use for general labs. Methods The red blood cells of 10 healthy blood donors( O/AB and Rh D-positive) were used to prepare the red blood cell quality control product. Fresh plasma( O/AB and Rh D positive) and anti-D( Ig G) human plasma were used to prepare the plasma quality control product. The evaluation of the prepared IQC products was performed regarding repeatability,stability,optimum/routine condition comparison and method comparison( with microcolumn gel method and coagulation amine method). Results The in-batch repeatability was measured by CVs,which were all below 10% with no significant difference( P>0. 05). There was no significant difference in the results regarding storage time,condition and methods( P > 0. 05). Quality control tests were conducted for the next six months and the control rate was 100%. Conclution A novel IQC for blood transfusion compatibility testing was developed with consistent repeatability,high stability and decent practicability.
Objective The aim of this study was to prepare a series of internal quality control( IQC) products for blood transfusion compatibility tests,which should be easy-to-use for general labs. Methods The red blood cells of 10 healthy blood donors( O/AB and Rh D-positive) were used to prepare the red blood cell quality control product. Fresh plasma( O/AB and Rh D positive) and anti-D( Ig G) human plasma were used to prepare the plasma quality control product. The evaluation of the prepared IQC products was performed regarding repeatability,stability,optimum/routine condition comparison and method comparison( with microcolumn gel method and coagulation amine method). Results The in-batch repeatability was measured by CVs,which were all below 10% with no significant difference( P>0. 05). There was no significant difference in the results regarding storage time,condition and methods( P > 0. 05). Quality control tests were conducted for the next six months and the control rate was 100%. Conclution A novel IQC for blood transfusion compatibility testing was developed with consistent repeatability,high stability and decent practicability.
引文
[1]中华人民共和国卫生部.医疗机构临床实验室管理办法.2006-6-1.
[2]于洋,马春娅,冯倩,等.自制输血相容性检测室内质控品保存条件的研究.中国实验血液学杂志,2010,18(3):780-784.
[3]于洋,汪德清.输血相容性检测室内质量控制体系建设.中国输血杂志,2009,22(1O):790-792.
[4]于洋,马春娅,冯倩,等.输血相容性检测室内质控品制备技术优化与性能评价.中国输血杂志,2011,24(4):26-30.
[5]Thompson M,Wood R.Harmonised guidelines for IQC in analyticcalchemistry laboratories.Pure Appl Chem,1995,67(4):649-666.
[6]Working Party of the British Committee for Standards in Hematology Blood Transfusion Task Force.Guidelines for compatibility procedures in blood transfusion laboratories.Transfus Med,2004,14(1):59-73.
[7]International Organization for Standardization(ISO).Medical laboratories particular requirements for quality and competence.Ceneva:ISO Standard 15189:2007,5.6.
[8]American Association of Blood Banks.Technical manual(16thed).Bethesda:AABB,2008:15-39.
[2]于洋,马春娅,冯倩,等.自制输血相容性检测室内质控品保存条件的研究.中国实验血液学杂志,2010,18(3):780-784.
[3]于洋,汪德清.输血相容性检测室内质量控制体系建设.中国输血杂志,2009,22(1O):790-792.
[4]于洋,马春娅,冯倩,等.输血相容性检测室内质控品制备技术优化与性能评价.中国输血杂志,2011,24(4):26-30.
[5]Thompson M,Wood R.Harmonised guidelines for IQC in analyticcalchemistry laboratories.Pure Appl Chem,1995,67(4):649-666.
[6]Working Party of the British Committee for Standards in Hematology Blood Transfusion Task Force.Guidelines for compatibility procedures in blood transfusion laboratories.Transfus Med,2004,14(1):59-73.
[7]International Organization for Standardization(ISO).Medical laboratories particular requirements for quality and competence.Ceneva:ISO Standard 15189:2007,5.6.
[8]American Association of Blood Banks.Technical manual(16thed).Bethesda:AABB,2008:15-39.