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一种新型抗-k(抗-KEL2)单克隆试剂的评估

Evaluation of a new monoclonal anti-k (anti-KEL2) reagent.

作者信息

Strobel Erwin

机构信息

Department Medizinische Mikrobiologie, Immunologie und Krankenhaushygiene, Medizet, Städtisches Klinikum München GmbH, Germany.

出版信息

Clin Lab. 2010;56(9-10):385-9.

PMID:21086783
Abstract

BACKGROUND

The first monoclonal anti-k (anti-KEL2) reagent of the IgM-class (clone: LK1) for the tube spin method is now commercially available. As this reagent is directly agglutinating in contrast to conventional polyclonal anti-k reagents requiring an indirect antiglobulin test, we studied the reaction characteristics of this new reagent carefully before starting its use in our routine blood grouping laboratory.

METHODS

The titer of the monoclonal anti-k reagent (manufacturer: Biotest, D-63303 Dreieich) was compared with that of two polyclonal anti-k reagents. The avidity was tested with 2 K+k+ red blood cells (RBCs). The reactivity was examined by 10 K+k+ and 3 K-k+ blood samples. Specificity was tested with 12 k- RBCs from several antibody identification panels and from well known blood donors. The influence of a positive direct antiglobulin test was examined by using antibody-loaded RBCs.

RESULTS

The titer of the monoclonal reagent was the same as that of one of the polyclonal reagents and one geometrical titer step lower than that of the other. At immediate spin and after 5, 10 and 15 minutes incubation at room temperature the reactions of the monoclonal reagent were clear. All 10 K+k+ and all 3 K-k+ blood samples were detected. No false positive reactions were found with RBCs carrying the most important antigens of the ABO, Lewis, P, Rhesus, Kell, Duffy, Kidd, Lutheran, Colton, and Cartwright system. After loading k- D+ RBCs with an incomplete anti-D no false positive reactions were seen. Loading K-k+ RBCs with incomplete anti-k also had no significant influence on the reaction.

CONCLUSIONS

Several general advantages of monoclonal reagents of the IgM-class were seen in the new monoclonal anti-k as well: direct agglutination without an indirect antiglobulin test; rapid and simple performance; use in a saline milieu also allowing the examination of RBCs with a positive direct antiglobulin test; lack of false positive reactions caused by contaminating antibodies in the reagent. As in Germany two different reagents must be used for testing a RBC antigen, a further anti-k reagent with a different monoclonal antibody of the IgM-class would be a useful addition.

摘要

背景

用于试管旋转法的首个IgM类单克隆抗-k(抗-KEL2)试剂(克隆:LK1)现已上市。由于该试剂与需要间接抗球蛋白试验的传统多克隆抗-k试剂不同,具有直接凝集作用,因此在我们常规血型实验室开始使用该试剂之前,我们仔细研究了这种新试剂的反应特性。

方法

将单克隆抗-k试剂(生产商:Biotest,德国德赖艾希,邮编63303)的效价与两种多克隆抗-k试剂的效价进行比较。用2个K+k+红细胞(RBC)检测亲和力。用10份K+k+和3份K-k+血样检测反应性。用来自多个抗体鉴定板和知名献血者的12个k-红细胞检测特异性。通过使用负载抗体的红细胞检测阳性直接抗球蛋白试验的影响。

结果

单克隆试剂的效价与其中一种多克隆试剂相同,比另一种低一个几何效价梯度。在立即离心以及在室温下孵育5、10和15分钟后,单克隆试剂的反应清晰。所有10份K+k+血样和所有3份K-k+血样均被检测到。携带ABO、Lewis、P、Rh、Kell、Duffy、Kidd、Lutheran、Colton和Cartwright系统最重要抗原的红细胞未发现假阳性反应。用不完全抗-D负载k- D+红细胞后未出现假阳性反应。用不完全抗-k负载K-k+红细胞对反应也无显著影响。

结论

新型单克隆抗-k试剂也体现了IgM类单克隆试剂的几个普遍优点:无需间接抗球蛋白试验即可直接凝集;操作快速简便;可在盐水环境中使用,也可用于检测直接抗球蛋白试验阳性的红细胞;试剂中污染抗体不会引起假阳性反应。由于在德国检测红细胞抗原必须使用两种不同的试剂,因此,另一种具有不同IgM类单克隆抗体的抗-k试剂将是一种有益的补充。

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