背景:意外的同种抗体鉴定是很困难的血清学测试,需要深入了解抗体行为,识别规则,了解抗原的接合性和剂量现象。使用基于抗体特征的算法的软件现在可用于解释同种抗体的特异性。进行了一项研究,以评估与手动抗体鉴定方法相比,一种此类软件(Resolvigen)用于抗体鉴定的有效性。
方法:该研究是一项回顾性观察性研究,其中使用Resolvigen软件(OrthoClinicalDiagnostics,约翰逊和约翰逊,Raritan,NJ,美国),并研究了手动方法和软件方法之间的协议。Resolvigen软件也进行了有用性评估,通过使用Likert量表对研究人员进行问卷调查,以方便使用并预测未来的使用情况。
结果:手动和自动方法的结果之间的一致性范围从单一抗体的98.6%到两种抗体的65%(p=0.000)。Resolvigen软件非常有用,易于使用,并具有较高的预测未来使用量。
结论:本研究得出结论,Resolvigen可以替代手动方法或用作常规手动方法的佐剂。
BACKGROUND: Unexpected allo-antibody identification is difficult serological test requiring in-depth knowledge of antibody behavior, identification rules, knowledge of zygosity of antigens and dosage phenomenon. Software which uses an algorithm based on characteristics of antibodies is now available to interpret specificity of allo-antibody. A study was undertaken to evaluate the effectiveness of one such software (Resolvigen) for antibody identification compared with manual antibody identification method.
METHODS: The study was a retrospective observational study where 238 allo-antibody results were re-evaluated using Resolvigen software (Ortho Clinical Diagnostics, Johnson and Johnson, Raritan, NJ, USA) and agreement between manual and software approaches was studied. Resolvigen software was also evaluated for usefulness, ease of use and predicted future usage by administering investigators a questionnaire with Likert scale.
RESULTS: Agreement between the results of manual and automated methods ranged from 98.6% for single antibody to 65% for two antibodies (p = 0.000). Resolvigen software came out as very useful, easy to use, and with high predicted future usage.
CONCLUSIONS: This study concludes that Resolvigen can either replace manual method or be used as adjuvant to routine manual method.