Harach Mary E, Gould Joy M, Brown Rosemary P, Sanders Tricia, Herman Jay H
Quality Assurance Coordinator, Thomas Jefferson University Hospital, Department of Transfusion Medicine.
Blood Bank Supervisor, Thomas Jefferson University Hospital, Department of Transfusion Medicine.
Immunohematology. 2018 Sep;34(3):93-97.
The inherent tradeoff between sensitivity and specificity in the detection of unexplained antibodies has been the objective of many studies, editorials, and journal articles. Many publications note that no method is capable of detecting all clinically significant antibodies while avoiding all clinically insignificant antibodies. This study describes the frequency of nonspecific reactivity and unexplained reactivity in solid-phase testing, along with the subsequent development of specific antibodies (Abs). In this study, nonspecific reactivity (NS) is defined as method-specific panreactivity detected by solid-phase testing only, with no reactivity in other methods. Unexplained reactivity (UR) is defined as reactivity present and detectable in all test methods after all clinically significant antibodies were ruled out following a standard antibody identification algorithm using selected cell panels. This retrospective study evaluated antibody detection tests of patients at a single center for 2 years using two automated solid-phase instruments that used the same three-cell antibody detection test. Antibody identification was performed with solid-phase panels supplemented with a polyethylene glycol tube method as needed. Of the 1934 (5%) samples with a positive antibody detection test, 29 had unavailable work-up data, leaving 1905 (98.5%) samples eligible for inclusion in the study. The data revealed the following: Ab only 999 (52.4%); UR only 429 (22.5%); Ab and UR 227 (11.9%); NS only 206 (10.8%); Ab and NS 24 (1.3%); UR and NS 14 (0.7%); and Ab, UR, and NS 6 (0.3%). Patients with a positive follow-up antibody detection test had UR and NS replaced with a specific Ab in 23 of 656 UR (3%) and 8 of 230 NS (3%) cases, respectively. Additionally, six patients with UR developed a specific Ab along with persistent UR, and no patients with persistent NS developed a specific Ab. The study concluded that both UR and NS can be encountered in solid-phase testing, and both UR and NS can persist in follow-up testing. Specific Ab was observed to replace UR in a few patients.
在检测无法解释的抗体时，灵敏度和特异性之间固有的权衡一直是许多研究、社论和期刊文章的主题。许多出版物指出，没有一种方法能够在避免所有临床无意义抗体的同时检测出所有具有临床意义的抗体。本研究描述了固相检测中非特异性反应性和无法解释的反应性的频率，以及随后特异性抗体（Abs）的产生情况。在本研究中，非特异性反应性（NS）定义为仅通过固相检测检测到的方法特异性全反应性，在其他方法中无反应性。无法解释的反应性（UR）定义为在使用选定细胞板按照标准抗体鉴定算法排除所有具有临床意义的抗体后，在所有检测方法中均存在且可检测到的反应性。这项回顾性研究使用两种使用相同三细胞抗体检测试验的自动化固相仪器，对一个中心的患者进行了为期两年的抗体检测试验评估。必要时，使用补充有聚乙二醇试管法的固相板进行抗体鉴定。在1934份（5%）抗体检测试验呈阳性的样本中，有29份的检查数据不可用，剩下1905份（98.5%）样本符合纳入本研究的条件。数据显示如下：仅为抗体999份（52.4%）；仅为无法解释的反应性429份（22.5%）；抗体和无法解释的反应性227份（11.9%）；仅为非特异性反应性206份（10.8%）；抗体和非特异性反应性24份（1.3%）；无法解释的反应性和非特异性反应性14份（0.7%）；以及抗体、无法解释的反应性和非特异性反应性6份（0.3%）。在抗体检测试验呈阳性的随访患者中，656份无法解释的反应性病例中有23份（3%）、230份非特异性反应性病例中有8份（3%）分别被特异性抗体取代。此外，6名具有无法解释的反应性的患者产生了特异性抗体并伴有持续的无法解释的反应性，而没有持续存在非特异性反应性的患者产生特异性抗体。该研究得出结论，在固相检测中可能会遇到无法解释的反应性和非特异性反应性，并且两者在随访检测中都可能持续存在。观察到少数患者的无法解释的反应性被特异性抗体取代。
