Cognein P, Costa A, Giacosa A
Clinical Nutrition Unit, National Institute for Cancer Research-IST, Genoa, Italy.
Eur J Cancer Prev. 1994 Nov;3(6):457-63. doi: 10.1097/00008469-199411000-00002.
Diagnosis and successful eradication of Helicobacter pylori infection has been shown to be significantly related to symptom improvement in patients affected by chronic gastritis, duodenal and gastric ulcer. There is, therefore, an increasing need for the development of new, easy to use, reliable and non-invasive techniques to detect this organism. One such test is Flex-Sure (SmithKline Diagnostics Inc., United States), a new, rapid immunochromatographic test which requires a drop of the patient's serum to be placed on the absorbent pad of a strip. If specific antibodies to H. pylori are present a red colour line appears. The present study compared Flex-Sure with a homologous quantitative immunoenzymatic test (HM-CAP, EPI, US) using the same antigen (high molecular weight protein), the second generation GAP test (Bio-Rad, USA), a rapid urease test, culture and histology in a cohort of dyspeptic patients. We produced a semiquantitative visual scale with which to perform this comparison. Our results show that Flex-Sure possesses a sensitivity of 96.1%, a specificity of 73.9%, an overall accuracy of 78.8%, a positive predictive value of 72% and a negative predictive value of 91.6%. It showed a highly significant correlation with histological and cultural results (P < 0.001), and with the other serological tests (P < 0.0001). Based on our data we conclude that Flex-Sure may yield quick (within 4 min), simply readable, qualitative, and according to our colourimetric scale, even semiquantitative results. Furthermore, it does not require any sample dilution, any particular equipment, or any specialized training for the operator.
已证明，幽门螺杆菌感染的诊断和成功根除与慢性胃炎、十二指肠溃疡和胃溃疡患者的症状改善显著相关。因此，越来越需要开发新的、易于使用、可靠且非侵入性的技术来检测这种微生物。一种这样的检测方法是Flex-Sure（美国史克必成诊断公司），这是一种新型快速免疫层析检测，只需将一滴患者血清滴在试纸条的吸收垫上。如果存在针对幽门螺杆菌的特异性抗体，就会出现一条红线。本研究在一组消化不良患者中，将Flex-Sure与使用相同抗原（高分子量蛋白）的同源定量免疫酶检测（HM-CAP，EPI，美国）、第二代GAP检测（美国伯乐公司）、快速尿素酶检测、培养和组织学进行了比较。我们制作了一个半定量视觉量表来进行此项比较。我们的结果表明，Flex-Sure的灵敏度为96.1%，特异性为73.9%，总体准确率为78.8%，阳性预测值为72%，阴性预测值为91.6%。它与组织学和培养结果（P < 0.001）以及其他血清学检测（P < 0.0001）显示出高度显著的相关性。根据我们的数据，我们得出结论，Flex-Sure可以快速（4分钟内）得出简单可读的定性结果，并且根据我们的比色量表，甚至可以得出半定量结果。此外，它不需要任何样品稀释、任何特殊设备，也不需要对操作人员进行任何专门培训。
