Viiala Charlie H, Windsor Helen M, Forbes Geoff M, Chairman Simon O, Marshall Barry J, Mollison Lindsay C
Department of Gastroenterology, Sir Charles Gairdner Hospital, Perth, Australia.
J Gastroenterol Hepatol. 2002 Feb;17(2):127-30. doi: 10.1046/j.1440-1746.2002.02563.x.
The CLOtest and other rapid urease detection kits are widely used in the endoscopic diagnosis of Helicobacter pylori. A new formulation CLOtest has been developed with the goal of obtaining a positive result more rapidly. The aims of this study were to validate the sensitivity and specificity of the new test and compare the time taken for a positive result to be visible in both the new and standard CLOtest.
Patients presenting for endoscopy at three Western Australian hospitals were prospectively enrolled. Gastric mucosal biopsies were obtained for the standard and new CLOtest and for histology. Grading of color change was conducted by staff blinded to the type of CLOtest used and conducted according to a standardized color chart. Helicobacter pylori status was defined by the combination of a positive standard CLOtest and histology, against which the new CLOtest was compared. Results were obtained at 1, 3 and 24 h, and at one center, at 10 min intervals for the first hour.
Three hundred and thirty-five patients were enrolled. Eighty-eight Helicobacter pylori-positive individuals were identified. At 24 h, the new test correctly identified all 88, with one false-positive result (sensitivity 100%, specificity 99.6%). At 1 h, sensitivity was 93% with a number of early false-positive results reducing specificity to 96%. Compared to the current CLOtest, the new formulation became positive faster at 20 min (P = 0.001, n = 51), but was similar at 1 h (P = 0.06, n = 88) and equivalent at 3 h.
The new formulation CLOtest is sensitive and specific, with a trend to give early positive results more quickly, although accuracy at 3 and 24 h is the same.
CLO检测试剂盒及其他快速尿素酶检测试剂盒广泛应用于幽门螺杆菌的内镜诊断。已研发出一种新型CLO检测试剂盒，目标是更快获得阳性结果。本研究旨在验证新型检测的敏感性和特异性，并比较新型与标准CLO检测出现阳性结果所需时间。
前瞻性纳入西澳大利亚州三家医院接受内镜检查的患者。获取胃黏膜活检组织用于标准及新型CLO检测和组织学检查。由不了解所使用CLO检测试剂盒类型的工作人员根据标准化色卡对颜色变化进行分级。幽门螺杆菌感染状态通过标准CLO检测阳性和组织学检查结果相结合来定义，并与新型CLO检测结果进行比较。分别在1小时、3小时和24小时获取结果，在一个中心，第1小时内每隔10分钟获取一次结果。
共纳入335例患者。鉴定出88例幽门螺杆菌阳性个体。24小时时，新型检测正确识别出所有88例阳性，有1例假阳性结果（敏感性100%，特异性99.6%）。1小时时，敏感性为93%，一些早期假阳性结果使特异性降至96%。与现行CLO检测相比，新型试剂盒在20分钟时更快出现阳性（P = 0.001，n = 51），但1小时时相似（P = 0.06，n = 88），3小时时相当。
新型CLO检测试剂盒敏感且特异，虽3小时和24小时时准确性相同，但有更快出现早期阳性结果的趋势。
