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一项针对印度人群的输血前检测中使用类型和筛选方法与传统的类型和交叉配血政策的多中心前瞻性观察研究。

A multicenter prospective observational study on the use of type and screen method versus conventional type and crossmatch policy for pre-transfusion testing in the Indian population.

机构信息

Rotary TTK Blood Center, Bangalore Medical Services Trust, Bengaluru, India.

Transfusion Medicine, SPS Hospitals Ludhiana, Punjab, India.

出版信息

Immunohematology. 2022 Sep 22;38(3):100-105. doi: 10.21307/immunohematology-2022-050. Print 2022 Sep 1.

Abstract

Despite knowing the benefits of the type and screen (TS) method in pre-transfusion testing (PTT), most transfusion centers in developing countries continue to be reluctant to adopt a TS strategy over the conventional type and antihuman globulin (AHG) crossmatch (TX) policy in their routine laboratory practice because of the cost of obtaining antibody screening reagents. To generate strong evidence, this multicenter, observational study was conducted in which we collected data prospectively over a 1-year period from six major blood centers in India. The primary objective of this study was to identify the discordance between TS and TX results. A secondary objective was to identify the allo-antibody specificity in patients with positive antibody detection tests. All patients with orders for red blood cell transfusion who met patient selection criteria were subjected to parallel testing by column agglutination technology (CAT) for both the antibody detection test (screen) using a commercial three-cell panel and for the AHG crossmatch. A total of 21,842 patients were tested. In 148 patients with incompatible crossmatches, samples from six patients gave negative results with the antibody detection test, whereas the antibody detection test was positive in samples from 118 patients among the 21,694 crossmatch-compatible cases. The TS approach achieved a positive percent agreement of 95.95 and was found to be significantly effective in preventing the transfusion of serologically incompatible blood. The risk associated with abbreviating the AHG crossmatch was found to be 0.009 percent. Most of the identified clinically significant alloantibodies were directed to Rh antigens (D>E>c>C>e), followed by anti-K and anti-M. This study has generated sufficient robust data for the Indian population by including patients from all major geographical areas of the country and concluded a satisfactory agreement level as well as non-inferiority to the current PTT policy. Therefore, TS policy can be implemented in developing countries with no compromise on blood safety, provided sufficient technical and infrastructural support are available.

摘要

尽管了解了输血前检测(PTT)中类型和筛查(TS)方法的益处,但由于获得抗体筛查试剂的成本,大多数发展中国家的输血中心在常规实验室实践中仍然不愿意采用 TS 策略替代传统的类型和抗人球蛋白(AHG)交叉配型(TX)策略。为了产生强有力的证据,这项多中心观察性研究从印度的六个主要血液中心前瞻性地收集了为期一年的数据。该研究的主要目的是确定 TS 和 TX 结果之间的不一致。次要目标是确定抗体检测呈阳性的患者中的同种异体抗体特异性。所有符合患者选择标准且需要红细胞输血的患者均接受平行检测,采用柱凝集技术(CAT)对商业三细胞面板进行抗体检测(筛查)和 AHG 交叉配型。共有 21842 名患者接受了检测。在 148 名交叉配型不合的患者中,6 名患者的样本抗体检测(筛查)结果为阴性,而在 21694 名交叉配型相容的患者中,有 118 名患者的抗体检测结果为阳性。TS 方法的阳性百分比符合率为 95.95%,在防止输注血清学不相容的血液方面效果显著。缩短 AHG 交叉配型的风险被发现为 0.009%。大多数鉴定出的具有临床意义的同种异体抗体针对 Rh 抗原(D>E>c>C>e),其次是抗-K 和抗-M。这项研究通过纳入来自印度所有主要地理区域的患者,为印度人群提供了足够有力的数据,并得出了与当前 PTT 政策相似的协议水平和非劣效性。因此,只要提供足够的技术和基础设施支持,就可以在不影响血液安全的情况下在发展中国家实施 TS 政策。

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