背景:花生嗜碱性粒细胞活化试验(BAT)已证明对肝素化血液具有出色的诊断准确性,但它的临床实用性受到这种抗凝剂中储存的样品稳定性短的限制。
目的:使用EDTA抗凝血,这些调查确定了花生BAT样品的稳定性是否可以延长到2天,目前通过美国参考实验室提供的诊断测试的最低稳定性要求。
方法:花生非过敏性对照(NAC),花生IgE致敏(PS),6个月至17岁的花生过敏(PA)儿童从KaiserPermanente南加州的成员中招募。从参与者收集EDTA抗凝血样本,送到一个集中的实验室,并在4℃下储存用于1和2天后进行花生BAT测试。
结果:使用23名非盲参与者的花生BAT结果来建立样本排斥和解释标准,随后在一项涉及112名其他儿童的前瞻性双盲研究中进行了验证(39-NAC,36-PS,37-PA)。在每个研究日测试的105份盲血样本中,88(84%)天1和90(86%)天2花生BAT结果被认为是可解释的,诊断准确率分别为95.5%和94.4%,分别。此外,所有可解释的PA结果均为阳性(100%敏感性).
结论:使用远程采集的EDTA抗凝血样本,测试前1天和2天,研究结果突出了花生BAT的良好诊断性能特征,并提供了进一步的证据,表明该测试可以很容易地通过感兴趣的商业参考实验室进行临床使用。
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSIONS: 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.