Academic Journal

Comparison of agar gel (CLOtest) or reagent strip (PyloriTek) rapid urease tests for detection of Helicobacter pylori infection.

Bibliographic Details
Title: Comparison of agar gel (CLOtest) or reagent strip (PyloriTek) rapid urease tests for detection of Helicobacter pylori infection.
Authors: Yousfi MM; Department of Medicine, Veterans Affairs Medical Center and Baylor College of Medicine, Houston, Texas 77030, USA., El-Zimaity HM, Cole RA, Genta RM, Graham DY
Source: The American journal of gastroenterology [Am J Gastroenterol] 1997 Jun; Vol. 92 (6), pp. 997-9.
Publication Type: Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, U.S. Gov't, Non-P.H.S.
Language: English
Journal Info: Publisher: Wolters Kluwer Health Country of Publication: United States NLM ID: 0421030 Publication Model: Print Cited Medium: Print ISSN: 0002-9270 (Print) Linking ISSN: 00029270 NLM ISO Abbreviation: Am J Gastroenterol Subsets: MEDLINE
Imprint Name(s): Publication: <2019-> : [Philadelphia, PA] : Wolters Kluwer Health
Original Publication: New York, Elsevier Science, -2003.
MeSH Terms: Agar* , Helicobacter pylori* , Reagent Strips* , Urease*, Helicobacter Infections/*diagnosis, Dyspepsia/diagnosis ; Gastric Mucosa/microbiology ; Gastric Mucosa/pathology ; Gastroesophageal Reflux/diagnosis ; Peptic Ulcer/diagnosis ; Pyloric Antrum/microbiology ; Pyloric Antrum/pathology ; Stomach Neoplasms/diagnosis ; Adult ; Aged ; Biopsy ; Coloring Agents ; Confidence Intervals ; False Negative Reactions ; False Positive Reactions ; Female ; Humans ; Male ; Middle Aged ; Prospective Studies ; Sensitivity and Specificity
Abstract: Objective: Rapid urease tests (RUTs) are used commonly as a convenient method to detect Helicobacter pylori infection. New rapid tests have been commercially available with promotional literature suggesting enhanced utility. We compared CLOtest to a new reagent strip RUT, PyloriTek.
Methods: Gastric antral mucosal biopsy specimens were obtained from 102 patients for comparison between CLOtest and PyloriTek (204 specimens). Biopsy specimens obtained from a nearby area were stained using the Genta stain for determination of H. pylori status. The RUT to be used first was selected randomly.
Results: Sixty-five of the 102 patients had peptic ulcer disease, two had gastric cancer, and 35 had dyspepsia; 61 patients had active H. pylori infection. There were one false-negative and three false-positive CLOtest results, compared with one false-negative and 13 false-positive PyloriTek results (p < 0.02 for incorrect categorization with PyloriTek). Sensitivity and specificity were 98 and 92% compared with 98 and 68% for CLOtest and PyloriTek, respectively. An erroneous categorization of H. pylori status occurred in 3.9% (95% confidence interval [CI]: 1-9.7%) with CLOtest compared with 13.7% (95% CI: 7.7 -22%) with PyloriTek. When the PyloriTek was scored at 1 h (0-1 h) after obtaining the specimen, the accuracy improved; erroneous categorization of H. pylori status occurred in only 2.9% (95% CI: 0.6-8.3%).
Conclusion: Used according to manufacturer instructions, the new reagent strip RUT PyloriTek has too many false-positive results for use in a clinical situation. In contrast, when the test was interpreted within 1 h, accuracy was comparable to that of CLOtest.
Comments: Comment in: Am J Gastroenterol. 1997 Nov;92(11):2136.. (PMID: 9362222)
Substance Nomenclature: 0 (Coloring Agents)
0 (Reagent Strips)
9002-18-0 (Agar)
EC 3.5.1.5 (Urease)
Entry Date(s): Date Created: 19970601 Date Completed: 19970703 Latest Revision: 20151119
Update Code: 20260130
PMID: 9177518
Database: MEDLINE
Description
ISSN:0002-9270