目的：研制均一性、稳定性良好、适用于定量检测的葡萄糖-6-磷酸脱氢酶(G6 PD)冻干质控物,为广西 G6 PD缺乏症筛查和确诊提供质量保证。方法使用健康献血者抗凝全血做基质,按不同比例加入小剂量 G6 PD纯分析物,制备正常、缺乏两个不同水平G6PD全血质控物。分装后使用冷冻干燥。参照CNAS-GL03《能力验证样品均匀性和稳定性评价指南》要求,对复溶后质控物进行均匀性、稳定性评价。用国内不同品牌的定量试剂盒做适用性评价。与进口质控品相比较应用于室内质量控制。结果均匀性检验结果显示,样品分装、冻干、复溶后 G6 PD检测值差异均无统计学意义(P>0.05)。在预期观察时间内,2~8℃未开瓶质控物可稳定1年,开瓶可稳定3 d。用于不同定量试剂盒检测,定性结果符合率一致,定量结果具有可比性。用于室内质量控制,朗道质控品和自制质控物在正常、缺乏两个不同水平的变异系数(CV)分别是2.60%、5.92%和2.99%、6.67%。结论自制 G6PD冻干质控物有良好的均匀性、稳定性,适用于定量检测试剂,并能应用于室内质量控制,满足广西 G6 PD筛查实验室室间质量评价需求。%Objective To prepare the homogeneity,stability and applicability of lyophilized control mate-rials for quantitative determination of glucose-6-phosphate dehydrogenase (G6PD),and to provide quality as-surance for Guangxi G6PD deficiency screening and diagnosis. Methods The anticoagulated whole blood from healthy volunteers was used as the matrix.A small dose of G6PD pure analyte at different proportions was added to matrix for preparation two different levels of G6PD-lyophilized normal and deficient control ma-terials.Freeze-drying was performed after aliquots.According to CNAS-GL03 “Guidance on Evaluating the Homogeneity and Stability of Samples Used for Proficiency Testing”,the homogeneity and stability of quality-controls were evaluated after re-dissolution.The applicability was evaluated by different domestic brand quantification kits.Comparing the self-made control materials with the import control materials in interior quality control was done. Results One-way ANOVA analysis of homogeneity indicated that G6PD meas-urements had no statistical differences (P>0.05)after dispensing,lyophilization,re-dissolution of the con-trol materials.Within anticipation observation time,the sealed lyophilized control materials were stable for one year and the unsealed bottle controls were stable for 3 days at 2 to 8 ℃.Applying to different quantitative de-tection kits,the same coincidence rate was obtained by qualitative determination,and quantitative results were comparable.In internal quality control,the coefficient of variation (CV)in normal and deficient Randox quali-ty control materials and in normal and deficient homemade quality control materials was 2.60%,5.92% and 2. 99%,6.29%,respectively. Conclusion The homemade G6PD lyophilized control materials have better hom-ogeneity and stability,which can be applicable for quantitative detection and can be used in internal quality con-trol;and can meet the needs of Guangxi G6PD screening laboratories in internal quality evaluation.
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