Graham D Y, Evans D J, Peacock J, Baker J T, Schrier W H
Department of Medicine, Veterans Affairs Medical Center, Houston, Texas, USA.
Am J Gastroenterol. 1996 May;91(5):942-8.
There is a need for accurate and rapid tests for Helicobacter pylori infection especially since the recent National Institutes of Health Consensus Development Conference on H. pylori in peptic ulcer disease charged the medical community with treating H. pylori infection in all patients with H. pylori and ulcer disease.
We prospectively compared a simple, rapid serological test (FlexSure HP, SmithKline Diagnostics) for the detection of serum IgG antibodies against H. pylori with another rapid test (QuickVue, Quidel) and two enzyme immunoassays (HM-CAP, Enteric Products, and PyloriStat, BioWhittaker). Serum samples from 551 individuals including both symptomatic patients (196) and asymptomatic volunteers (355) were tested for the presence of IgG antibodies against H. pylori. The presence or absence of active H. pylori infections was determined using the [13C]-urea breath test.
All of the serological tests performed well. FlexSure HP had calculated sensitivity, specificity, and accuracy of 94.4, 87.6, and 91.1%, respectively, relative to the urea breath test. In 49 of the 551 samples, the urea breath test and FlexSure HP did not agree. Those samples were tested with HM-CAP immunoassay to confirm presence or absence of IgG antibodies against H. pylori. After the resolution of the discordant results, the sensitivity, specificity, and accuracy of FlexSure HP were 96.0, 95.1, and 95.6%, respectively, and were comparable to HM-CAP and PyloriStat. FlexSure HP was compared with histology or culture in 75 cases, and the accuracy was 100%. FlexSure HP and QuickVue were compared using 200 serum samples. FlexSure HP was more specific (88.7 vs 79.4%) and accurate (91 vs 84%) than QuickVue (p < 0.05 for both), relative to the urea breath test with discordant samples unresolved. FlexSure HP was also simpler to use, easier to interpret, and faster than QuickVue. FlexSure HP required no sample dilution, one reagent, four steps, and 5 min to complete.
FlexSure HP is an excellent option for in-office tests for the physician who desires immediate results or for small laboratories that do not have the volume of H. pylori testing to justify ELISA test formats.
尤其自从美国国立卫生研究院关于幽门螺杆菌在消化性溃疡疾病方面的共识发展会议要求医学界治疗所有幽门螺杆菌感染且患有溃疡疾病的患者以来，对幽门螺杆菌感染进行准确、快速检测的需求日益凸显。
我们前瞻性地比较了一种用于检测血清中抗幽门螺杆菌IgG抗体的简单、快速血清学检测方法（FlexSure HP，史克必成诊断公司）与另一种快速检测方法（QuickVue，奎德公司）以及两种酶免疫测定法（HM-CAP，肠道产品公司；PyloriStat，生物惠特克公司）。对包括有症状患者（196例）和无症状志愿者（355例）在内的551名个体的血清样本进行了抗幽门螺杆菌IgG抗体检测。使用[13C] - 尿素呼气试验确定是否存在活动性幽门螺杆菌感染。
所有血清学检测表现良好。相对于尿素呼气试验，FlexSure HP计算得出的敏感性、特异性和准确性分别为94.4%、87.6%和91.1%。在551份样本中的49份中，尿素呼气试验和FlexSure HP结果不一致。对这些样本用HM-CAP免疫测定法进行检测以确认是否存在抗幽门螺杆菌IgG抗体。在解决了不一致结果后，FlexSure HP的敏感性、特异性和准确性分别为96.0%、95.1%和95.6%，与HM-CAP和PyloriStat相当。在75例病例中对FlexSure HP与组织学或培养结果进行了比较，准确性为100%。使用200份血清样本对FlexSure HP和QuickVue进行了比较。相对于未解决不一致样本的尿素呼气试验，FlexSure HP比QuickVue更具特异性（88.7%对79.4%）和准确性（91%对84%）（两者p均<0.05）。FlexSure HP使用起来也更简单、更易于解读，且比QuickVue更快。FlexSure HP无需样本稀释，只需一种试剂，四个步骤，5分钟即可完成。
对于希望获得即时结果的医生进行办公室检测或对于幽门螺杆菌检测量不足以采用酶联免疫吸附测定法检测形式的小型实验室而言，FlexSure HP是一个绝佳选择。
