自制弱阳性质控品对无偿献血者进行ABO血型鉴定室内质控的可行性探讨

Feasibility of homemade weak positive control materials for voluntary blood donors ABO blood grouping of internal quality control

目的探讨自制弱阳性质控品对无偿献血者进行ABO血型鉴定室内质控的可行性以及使用后提高亚型检出率的效果。方法①选择本站日常工作中采集〈6d，各项传染性指标检测均为阴性，血型鉴定分别被确定为A亚型和B亚型，且弱抗原与抗-A、抗-B的反应强度均为1＋的无偿献血者血液，将其离心后分出2U浓缩红细胞，并进行甘油化后各等分为24份（2年用量）于-80℃冰箱冰冻保存。每月各取出1个分装单位的冰冻红细胞。融化洗涤后加入MAP红细胞保存液及硫酸庆大霉素，制备成A抗原和B抗原弱阳性质控品。②适量收集保存时间（6d，各项传染性指标检测均为阴性，不规则抗体检测均为阴性，无溶血和脂血的AB型、A型及B型血浆，在AB型血浆中分别加入一定比例的B型血浆和A型血浆，使其最终与Ac和Bc的凝集强度均为1＋时，各等分为24份（2年用量）于-30℃冰箱冰冻保存。每月各取出1个分装单位的冰冻血浆，融化后加入叠氮钠，制备成A抗体和B抗体弱阳性质控品。③制备好的质控品经检验科定标合格后，和每批无偿献血者标本同时进行ABO血型检测。当弱阳性质控品反应结果为阴性时，提示存在影响亚型检出的因素，应及时分析并采取纠正措施。④统计并比较弱阳性质控品使用前（2006年1月～2009年12月，对照组）和使用后（2010年1月～2013年12月，实验组）的ABO亚型检出率。结果①弱阳性质控品共有14次呈阴性反应结果，采取措施后均得到纠正。②对照组的ABO亚型检出率为0．25／万（2／79704），实验组的ABO亚型检出率为1．66／万（13，78415），两组差异有统计学意义（x2=8．25，P〈0．05）。结论本站自制弱阳性质控品应用于无偿献血者ABO血型鉴定的室内质控，可显著提高ABO亚型检出率．进一步保障无偿献血者ABO血型鉴定的准确性及临床输血的安全、有效性，具有一定的推广应用价值。

Objective To investigate the feasibility of homemade weak positive control materials for voluntary blood donors ABO blood grotiping of internal quality control as well as the effect of improving the use of subtype detection rate. Methods （1）The blood of voluntary blood donors were selected which acquisition time were less than 6 days,the infectious indicators were negative,blood type were identified as subtype A and subtype B,and the reaction strength of weak antigen and anti-A,anti-B were 1 ＋,2 U packed red blood cells were isolated after centrifugation,and each were divided into 24 parts （2-year amount） after glycerylated and were stored frozen at -80~C refrigerator.One aliquots unit of frozen red blood cells was removed each month,MAP red blood cells preservation solution and gentamicin sulfate were added after thawing wash,A antigen and B antigen weak positive control materials were prepared. （2）AB-type,A-type and B-type plasma were collected which acquisition time were less than 6 days,the infectious indicators were negative,irregular antibody test were negative,no hemolysis and lipemia, in the AB-type plasma were added a certain proportion of B-type plasma and A-type plasma,when its agglutination strength of Ac and Bc were l＋,each were divided into 24 parts （2-year amount） stored frozen at -30~C refrigerator.One aliquots unit of frozen plasma was removed each month,sodium azide was added after melting, A antibodies and B antibodies weak positive control materials＇were prepared.（3）Quality control mate- rials prepared were passed by the laboratory calibration,then it and each batch of voluntary blood donors specimen were taken ABO blood group detection simuhaneouslv.When weak ,ositive control materials reaction results were negative.sugested the presence of factors that affect the subtype -de-tected,it should timely analyze and take corrective action. （4）ABO subtype detection rate was analyzed before using weak positive control materials （January 2006 to December 2009,the control group） and after using weak positive control materials （January 2010 to December 2013,the experimental group）. Results （1）There were 14 times negative results of weak positive control materials,were corrected after taking the measures.（2）ABO subtype detection rate in the control group was 0.25/10 000 （2/79 704）,the experimental group was 1.66/10 000 （13/78 415）,the difference was significant （x2=8.25,P〈 0.05）. Coneltmion Homemade weak positive control materials for voluntary blood donors ABO blood grouping of internal quality control,can significantly increase the ABO subtypes detection rate,further protecting the accuracy and safety of clinical transfusion of ABO blood donors in the identification of effective nature,has a certain application value.