Department of Immune Diagnostics, Quest Diagnostics Nichols Institute, San Juan Capistrano, California.
Allergy and Immunology Clinics, Kaiser Permanente Southern California, San Diego, Los Angeles, and Pasadena, California.
Ann Allergy Asthma Immunol. 2024 Oct;133(4):445-452.e5. doi: 10.1016/j.anai.2024.06.022. Epub 2024 Jul 3.
The peanut basophil activation test (BAT) has demonstrated excellent diagnostic accuracy with heparinized blood, but its clinical utility is limited by the short stability of samples stored in this anticoagulant.
Using EDTA anticoagulated blood, these investigations determined if Peanut BAT sample stability can be extended to 2 days, the minimum stability requirement for diagnostic tests currently offered through American reference laboratories.
Peanut non-allergic control (NAC), peanut IgE sensitized (PS), and peanut allergic (PA) children aged 6 months through 17 years were recruited from members of Kaiser Permanente Southern California. EDTA anti-coagulated blood samples were collected from participants, shipped to a centralized laboratory, and stored at 4oC for peanut BAT testing 1 and 2 days later.
Peanut BAT results for 23 unblinded participants were used to establish sample rejection and interpretation criteria that were subsequently validated in a prospective double-blind study involving 112 additional children (39-NAC, 36-PS, 37-PA). Of 105 blinded blood samples tested on each study day, 88 (84%) day-1 and 90 (86%) day-2 peanut BAT results were considered interpretable, with diagnostic accuracies of 95.5% and 94.4%, respectively. Moreover, all interpretable PA results were considered positive (100% sensitivity).
Using EDTA anti-coagulated blood samples collected remotely, 1 and 2 days before testing, study results highlight the favorable diagnostic performance characteristics of the peanut BAT and provide further evidence that the test could be readily operationalized for clinical use by interested commercial reference laboratories.
花生嗜碱性粒细胞激活试验（BAT）在使用肝素抗凝的血液时具有出色的诊断准确性，但由于肝素抗凝的样本保存稳定性差，其临床应用受到限制。
本研究使用 EDTA 抗凝的血液，旨在确定花生 BAT 样本的稳定性是否可以延长至 2 天，这是目前美国参考实验室提供的诊断检测的最短稳定性要求。
从 Kaiser Permanente Southern California 的成员中招募了年龄在 6 个月至 17 岁的花生非过敏对照（NAC）、花生 IgE 致敏（PS）和花生过敏（PA）儿童。从参与者采集 EDTA 抗凝血液样本，将其运送到中心化实验室，并在 4°C 下储存 1 天和 2 天后进行花生 BAT 检测。
使用 23 名未设盲参与者的花生 BAT 结果来建立样本拒绝和解释标准，随后在一项涉及 112 名额外儿童（39 名 NAC、36 名 PS、37 名 PA）的前瞻性双盲研究中进行验证。在每个研究日测试的 105 份盲血样本中，88 份（84%）第 1 天和 90 份（86%）第 2 天的花生 BAT 结果可解释，其诊断准确性分别为 95.5%和 94.4%。此外，所有可解释的 PA 结果均被认为是阳性（100%敏感性）。
使用 EDTA 抗凝的远程采集的血液样本，在测试前 1 天和 2 天进行检测，研究结果突出了花生 BAT 的良好诊断性能特征，并进一步证明该测试可以由有兴趣的商业参考实验室轻松应用于临床。
