用于诊断幽门螺杆菌的市售快速尿素酶试验的前瞻性比较

Prospective comparison of commercially available rapid urease tests for the diagnosis of Helicobacter pylori.

作者信息

Laine L, Lewin D, Naritoku W, Estrada R, Cohen H

机构信息

University of Southern California School of Medicine, Los Angeles 90033, USA.

出版信息

Gastrointest Endosc. 1996 Nov;44(5):523-6. doi: 10.1016/s0016-5107(96)70002-0.

DOI:10.1016/s0016-5107(96)70002-0

PMID:8934155

Abstract

BACKGROUND

Rapid urease testing is the initial endoscopic test of choice for the diagnosis of Helicobacter pylori. Determination of the relative diagnostic yields and times to a positive test for the different rapid urease tests is important for endoscopists. We compared three commercially available tests using histologic examination and culture as a gold standard.

METHODS

Patients undergoing upper endoscopy had six biopsy specimens taken from the antrum and six from the body with a large-channel biopsy forceps. Each set of six specimens was divided as follows: one each for CLOtest, Hpfast, and Pyloritek rapid urease tests; one for culture; and two for histologic examination (H&E, Genta). All tests were read every 15 minutes for 1 hour; the final reading for Pyloritek was at 1 hour. CLOtest and Hpfast were also read at 4 hours and 24 hours.

RESULTS

One hundred seventy-three sets of biopsy specimens from 87 patients were evaluated; 98 (57%) of the 173 sets were positive for H. pylori by histologic examination and/or culture. The mean and median times to a positive test were significantly less for Pyloritek (0.5 +/- 0.02 hour and 0.5 hour) than for CLOtest (2.0 +/- 0.6 hour and 0.75 hour) or Hpfast (2.2 +/- 0.6 hour and 0.5 hour). The sensitivities at the final readings were similar among the three tests (CLOtest: 93%; Hpfast: 88%; Pyloritek: 89%), but sensitivities at 1 hour were significantly better for Pyloritek (89%) than for CLOtest (71%) or Hpfast (66%). At 4 hours, sensitivities for CLOtest and Hpfast improved significantly and were not significantly different from those of Pyloritek. Specificities were 99% to 100% at all times for all three tests.

CONCLUSION

The three rapid urease tests, CLOtest, Hpfast, and Pyloritek, provide comparable results, with sensitivities around 90% and specificities around 100%. The Pyloritek becomes positive more rapidly than the CLOtest or Hpfast. If a reading is desired within 1 hour, the Pyloritek provides a greater sensitivity than the CLOtest or Hpfast without any sacrifice in specificity.

摘要

背景

快速尿素酶检测是诊断幽门螺杆菌的首选内镜初始检测方法。确定不同快速尿素酶检测的相对诊断率和检测出阳性结果的时间对内镜医师很重要。我们以组织学检查和培养作为金标准，比较了三种市售检测方法。

方法

接受上消化道内镜检查的患者用大通道活检钳从胃窦取6块活检标本，从胃体取6块活检标本。每组6块标本按如下方式分配：分别用于CLOtest、Hpfast和Pyloritek快速尿素酶检测各1块；用于培养1块；用于组织学检查（苏木精-伊红染色、银染色）2块。所有检测每15分钟读取一次结果，共读取1小时；Pyloritek的最终读数在1小时时进行。CLOtest和Hpfast在4小时和24小时时也进行读数。

结果

对来自87例患者的173组活检标本进行了评估；173组中的98组（57%）经组织学检查和/或培养显示幽门螺杆菌阳性。Pyloritek检测出阳性结果的平均时间和中位时间（0.5±0.02小时和0.5小时）显著短于CLOtest（2.0±0.6小时和0.75小时）或Hpfast（2.2±0.6小时和0.5小时）。三种检测方法最终读数时的敏感度相似（CLOtest：93%；Hpfast：88%；Pyloritek：89%），但Pyloritek在1小时时的敏感度（89%）显著高于CLOtest（71%）或Hpfast（66%）。在4小时时，CLOtest和Hpfast的敏感度显著提高，与Pyloritek的敏感度无显著差异。三种检测方法在所有时间的特异度均为99%至100%。

结论

CLOtest、Hpfast和Pyloritek这三种快速尿素酶检测方法提供了可比的结果，敏感度约为90%，特异度约为100%。Pyloritek比CLOtest或Hpfast更快出现阳性结果。如果希望在1小时内获得读数，Pyloritek比CLOtest或Hpfast具有更高的敏感度，且不牺牲特异度。