自制输血相容性检测室内质控品方法的建立与性能评价  

A novel in-door quality control strategy with off-market materials in transfusion compatibility testing and related evaluations

作　　者：孔文兵[1] 刘持翔 杨新革[1] 赵晖[1] 彭道波[1] 吕飘 周华友[1] 

机构地区：[1]南方医科大学南方医院输血科,广东广州510515

出　　处：《中国输血杂志》2017年第11期1225-1228,共4页Chinese Journal of Blood Transfusion

基　　金：国家高技术研究发展计划(863计划)(2013AA020201)

摘　　要：目的建立1种制备方便、质控品数量少,能有效控制输血相容检测质量的室内质控品制备方法和质控模式,并对其性能进行评价。方法将红细胞、血浆和红细胞保存液按1∶2∶4的比例混合,分别制成1号和2号全血质控品。将单克隆Ig G抗-D与AB型血浆按1∶256比例混合,制成3号血浆质控品。1号质控品用于血型和配血,2号质控品用于血型、抗筛和配血,3号质控品用于抗筛和配血。对3支自制室内质控品的均一性、稳定性和有效性进行评价。结果 1号质控品为A型Rh D阴性,2号质控品为B型Rh D阳性;2号质控品抗筛阴性,3号质控品抗筛阳性;1号质控品与2号质控品主侧配血强阳性,凝集强度为4+;3号质控品与2号质控品主侧配血阳性,凝集强度为2+;3号质控品与1号质控品主侧配血阴性。1号、2号质控品在4℃冰箱保存6周血浆抗体效价和红细胞抗原稳定;3号质控品在-20℃保存6个月,Ig G抗-D效价稳定;3支质控品稳定性检测变异系数(CV)均<10.0%。结论自制3支管室内质控品性能评价良好,质控品数量少,使用方便,能够满足输血相容性检测室内质控的要求。Objective To formulate a simple and effective internal quality control modality using Objectives： This study aims to establish a quality control（ QC） strategy based on a minimun number of off-market/self-made materials/reagent and evaluates its performance in real-life applications. Methods A set of quality control materials consisted of A/Rh D-negative RBC suspension（ Ctrl 1）,B/Rh D-positive RBC suspension（ Ctrl 2）,and AB plasma（ Ctrl 3） were made from donated blood,among which,Ctrl 1 and 2 were stored in a preservation solution while C were processed by an Ig G anti-D reagent. In Ctrl 1 and 2,erythrocytes,plasma and the erythrocyte preserving fluid were mixed at a ratio of 1 ∶2 ∶4. In Ctrl 3,Ig G anti-D was added to the AB plasma at a ratio of 1 ∶256. Ctrl 1 and Ctrl 2 were applied for the in-door quality control of blood group typing. Ctrl 2 and Ctrl 3 were designed for antibody screening tests. Ctrl 1,Ctrl 2 and Ctrl 3 combined manipulated the roles of donors or recipients in the crossing matching,respectively. Performance evaluations were conducted considering the following criteria： homogeneity,stability,and effectiveness. Results Ctrl 1 were A/Rh D-negative while Ctrl 2 were B/Rh D-positive. Antibody screening tests of Ctrl 2 and Ctrl 3 were negative and positive,respectively. In the crossmatching tests,the major crossmatch of Ctrl 1（ as recipient） and Ctrl 2（ as donor）,Ctrl 2（ as donor） and Ctrl 3（ as recipient）,Ctrl 1（ as donor） and Ctrl 3（ as recipient） resulted in incompatibility（ 4 ＋）,incompatibility（ 2 ＋） and compatibility,respectively. The RBC suspension can be stored at 4℃ for 6 months as the antibody titer and erythrocyte antigens of the suspension remained stable. Ctrl 3 can be kept in-20 ℃ for storage to maintain a bio-functional Ig G anti-D antibody titer. Each of the control materials scored CV 〈10% in stability testing. Conclusion Our in-door QC strategy with self-made/off-market QC materials showed promising homogeneity,stab

关 键 词：室内质控 自制质控品 输血相容性检测 性能评价 

分 类 号：R457.11[医药卫生—治疗学]