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Evaluation of a new formulation CLOtest.

Abstract：

BACKGROUND AND AIMS: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. METHODS: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. RESULTS: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. CONCLUSIONS: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.

journal_name

J Gastroenterol Hepatol

journal_title

Journal of gastroenterology and hepatology

authors

Viiala CH,Windsor HM,Forbes GM,Chairman SO,Marshall BJ,Mollison LC

doi

10.1046/j.1440-1746.2002.02563.x

subject

Has Abstract

pub_date

2002-02-01 00:00:00

pages

127-30

issue

2

eissn

0815-9319

issn

1440-1746

pii

2563

journal_volume

17

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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