国内医疗机构胎儿新生儿溶血病免疫血液学检测情况分析

Immunohematological Tests of Hemolytic Disease of the Fetus and Newborn:A Questionnaire Survey in Domestic Medical Facilities

目的调查目前国内胎儿新生儿溶血病(hemolytic disease of fetus and newborn,HDFN)实验室免疫血液学检测的开展情况,为制定HDFN实验室检测操作规范、检测标准及专家共识提供依据,以提高国内HDFN实验室检测水平。方法编写《胎儿新生儿溶血病实验室检测情况调查表》,并向国内医疗机构发放,调查产前、产后免疫血液学检查项目及检测方法,了解实验室质量控制情况,针对调查信息进行统计分析。结果回收调查问卷57份,统计结果如下:孕妇免疫血液学检测时机分布在妊娠各个时期,以10~20周为主(38.6%);产前免疫血液学检测项目主要包括孕妇ABO、RhD血型检测(95.7%)、丈夫ABO、RhD血型检测(63.8%)、孕妇不规则抗体筛查(93.6%)、抗体鉴定(83%)及抗体效价IgG抗-A(B)(83%)、不规则抗体(53.2%);应用于临床的cff-DNA(0%);破坏IgM抗体试剂选择0.1 mol/L 2-巯基乙醇(82.6%)、0.01 mol/L 2-流苏糖醇(23.9%);产后免疫血液学检测项目主要包括新生儿ABO、RhD血型(100%)、DAT试验(98.1%)、血清游离抗体试验(94.2%)、红细胞抗体放散试验(96.2%);红细胞抗体放散试验检测方法以热放散(40%)和酸放散(54%)为主;实验室质量控制:42.3%的单位开展室内质控,50%的单位开展室间质评,98.1%的单位有标准操作规程;血清抗体标准品参考(0%)。结论国内迫切需要建立HDFN实验室检测标准操作规程,统一方法学、参考范围以及质控监测,并形成专家共识。

Objective We investigated the current status of immunohematology laboratory tests for hemolytic disease of the fetus and newborn(HDFN)in China,and provided the basis for the establishment of performance specifications,test standards and expert consensus to improve the ability of laboratory tests for HDFN.Methods We compiled"the questionnaire of laboratory tests for hemolytic disease of the fetus and newborn"and distributed to the domestic medical facilities.The contents of the investigation included prenatal and postpartum immunohematologic tests,methods and laboratory quality control.We collected the survey data for statistical analysis.Results Fifty-seven questionnaires were collected,and the results were as follows:The timing of prernatal immunohematologic tests were performed at different times in pregnancy,mainly at 10 to 20 weeks(38.6%);prenatal immunohematologic tests mainly included ABO and RhD blood group type(95.7%),pregnant woman’s husband ABO and RhD blood group type(63.8%),irregular antibody screening(93.6%),antibody identification(83%)and antibody titers[anti-A/B antibody(83%),irregular antibody(53.2%)]and cell-free fetal DNA(cffDNA)(0%);reagents for destroying IgM antibodies were 0.1mol/L 2-mercaptoethanol(82.6%)and 0.01mol/L 2-fimbritol(23.9%);postpartum immunohematologic tests mainly included neonatal ABO and RhD blood group type(100%),direct antiglobulin test(98.1%),serum free antibody test(94.2%),red blood cell(RBC)antibody elution methods(96.2%);RBC antibody elution methods were heat elution(40%)and acid elution method(54%);the facilities that carried out laboratory quality control:42.3%internal quality assessment,50%external quality assessment,98.1%standard operating procedures;reference standards for serum antibody(0%).Conclusion There is an urgent need to establish HDFN laboratory standard operating procedures,standardization methods,reference range and quality control monitoring,and develop expert consensus.