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[通过间接抗球蛋白试验进行抗体筛查以及采用过滤和微孔板技术进行ABO血型鉴定的验证:稳健性评估]

[Validation of antibody screening by indirect antigloblin test and ABO blood typing by filtration and microplate techniques: assessment of robustness].

作者信息

Mannessier L, Delamaire M, Bouix O, Krause C, Roubinet F

机构信息

Etablissement français du sang Nord-de-France, site de Lille, 96, rue de Jemmapes, 59012 Lille cedex, France.

出版信息

Transfus Clin Biol. 2006 Oct;13(4):271-7. doi: 10.1016/j.tracli.2006.07.011. Epub 2006 Sep 25.

Abstract

According to requirements of the French Committee for Accreditation (Cofrac), it is essential to use validated and standardised methods in Immunohematology. This imposes first the knowledge of metrological tolerances for all the technics. Two multicenter studies were carried out to define the maximal acceptable deviations concerning incubation temperature and time, volumes of patient plasma and tests cells for antibody screening using indirect antiglobulin test on one hand and for reverse grouping on another hand. All equipment used (temperature test chamber, chronometer, pipettes) were calibrated according to Cofrac standards. The antibody screenings were performed manually using 3 different filtration systems: ID Diamed, Biovue Ortho and Scangel Biorad, the same tests cells, a standard 20 ng/mL anti RH1, a positive control anti KEL1 and a negative control; the reverse blood grouping was performed manually using the above mentionned filtration systems and microplate technic with the same A1 and B test cells. These two studies showed that all the tests from the multiples combinations of the above parameters gave the same results and allowed us to define a range of tolerance for 4 critical physical parameters involved in the antibody screening and blood typing.

摘要

根据法国认可委员会(Cofrac)的要求,在免疫血液学中使用经过验证和标准化的方法至关重要。这首先要求了解所有技术的计量公差。开展了两项多中心研究,以确定关于孵育温度和时间、患者血浆体积以及用于抗体筛查的检测细胞体积的最大可接受偏差,一方面是使用间接抗球蛋白试验进行抗体筛查,另一方面是进行反向血型鉴定。所有使用的设备(温度测试箱、计时器、移液器)均根据Cofrac标准进行校准。抗体筛查使用3种不同的过滤系统手动进行:ID Diamed、Biovue Ortho和Scangel Biorad,使用相同的检测细胞、标准的20 ng/mL抗RH1、阳性对照抗KEL1和阴性对照;反向血型鉴定使用上述过滤系统和微孔板技术手动进行,使用相同的A1和B检测细胞。这两项研究表明,上述参数的多种组合所进行的所有测试均得出相同结果,并使我们能够确定抗体筛查和血型鉴定中涉及的4个关键物理参数的公差范围。

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