BackgroundThe popularity of Low‐Titer O Whole Blood (LTOWB) for treating trauma patients requires that donor centers and transfusion services make decisions on what titer testing capabilities to institute and an appropriate titer level threshold. This study compared the titer results determined by four methods to find a rate of agreement.Study Design and MethodsIsohemagglutinin titers were tested on 300 plasma samples utilizing various methods, each determining IgM antibody levels by direct hemagglutination with A1 and B reference cells. The methods used were the Beckman Coulter's PK7300, Immucor's NEO Iris microplate technology, Ortho Clinical Diagnostics (OCD) Vision, and manual titrations.ResultsOnly 42.7% of the samples tested showed agreement across all methods on ABO isohemaglutinin titer levels and only 32.5% demonstrated “High titer” agreement. Sample agreement was close to 90% if the Immucor method was excluded. At a <1:256 titer level threshold, the pass rate was 94.3% for Immucor, 89.7% for the PK7300, 87.3% for manual testing, and 75.7% for OCD's gel method. Sensitivity and specificity rates at a ± 1 titer level were respectively 100% and 95.4% for OCD's gel, 73.7% and 100% for Immucor, and 100% and 99.6% for the PK7300. Overall method accuracy was 91.7% for Immucor, 90.3% for the PK7300, and 86.7% for OCD's gel method as compared to manual titration.ConclusionAll three automated methods perform comparably to the manual method at a ± 1 titer tolerance level. Based on these comparisons, a titer level of <1:256 would maximize LTOWB production regardless of the method used.

中文翻译：

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手动滴定法与用于筛选献血者以生产低滴度 O 全血的自动微孔板和凝胶滴定法的比较


背景低滴度 O 全血 (LTOWB) 在治疗创伤患者中的普及要求供体中心和输血服务机构决定要建立哪些滴度测试能力以及适当的滴度水平阈值。本研究比较了四种方法测定的滴度结果，以找出一致率。 研究设计和方法利用各种方法对 300 份血浆样本进行了异血凝素滴度测试，每种方法均通过与 A1 和 B 参考细胞直接血凝来测定 IgM 抗体水平。使用的方法是 Beckman Coulter 的 PK7300、Immucor 的 NEO Iris 微孔板技术、Ortho Clinical Diagnostics (OCD) Vision 和手动滴定。结果只有 42.7% 的测试样本显示所有方法对 ABO 异血凝素滴度水平的一致性，并且只有 32.5% 的样本表现出“高滴度”协议。如果排除 Immucor 方法，样本一致性接近 90%。在<1:256滴度水平阈值下，Immucor的通过率为94.3%，PK7300的通过率为89.7%，手动测试的通过率为87.3%，OCD凝胶方法的通过率为75.7%。 OCD 凝胶在 ±1 效价水平下的敏感性和特异性分别为 100% 和 95.4%，Immucor 为 73.7% 和 100%，PK7300 为 100% 和 99.6%。与手动滴定相比，Immucor 的总体方法准确度为 91.7%，PK7300 为 90.3%，OCD 凝胶方法为 86.7%。 结论 所有三种自动方法在 ±1 滴度公差水平上的表现与手动方法相当。根据这些比较，无论使用何种方法，<1:256 的滴度水平都将最大限度地提高 LTOWB 产量。