Academic Journal
Evaluation of a new formulation CLOtest.
| Title: | Evaluation of a new formulation CLOtest. |
|---|---|
| Authors: | VIIALA, CHARLIE H, WINDSOR, HELEN M, FORBES, GEOFF M, CHAIRMAN, SIMON O, MARSHALL, BARRY J, MOLLISON, LINDSAY C |
| Source: | Journal of Gastroenterology & Hepatology; Feb2002, Vol. 17 Issue 2, p127-130, 4p, 5 Charts |
| Subject Terms: | Medical equipment, Helicobacter pylori |
| Abstract: | 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. [ABSTRACT FROM AUTHOR] |
| Copyright of Journal of Gastroenterology & Hepatology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Complementary Index |
| FullText | Links: – Type: other Text: Availability: 0 |
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| Header | DbId: edb DbLabel: Complementary Index An: 6526736 RelevancyScore: 831 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 831.477966308594 |
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| Items | – Name: Title Label: Title Group: Ti Data: Evaluation of a new formulation CLOtest. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22VIIALA%2C+CHARLIE+H%22">VIIALA, CHARLIE H</searchLink><br /><searchLink fieldCode="AR" term="%22WINDSOR%2C+HELEN+M%22">WINDSOR, HELEN M</searchLink><br /><searchLink fieldCode="AR" term="%22FORBES%2C+GEOFF+M%22">FORBES, GEOFF M</searchLink><br /><searchLink fieldCode="AR" term="%22CHAIRMAN%2C+SIMON+O%22">CHAIRMAN, SIMON O</searchLink><br /><searchLink fieldCode="AR" term="%22MARSHALL%2C+BARRY+J%22">MARSHALL, BARRY J</searchLink><br /><searchLink fieldCode="AR" term="%22MOLLISON%2C+LINDSAY+C%22">MOLLISON, LINDSAY C</searchLink> – Name: TitleSource Label: Source Group: Src Data: Journal of Gastroenterology & Hepatology; Feb2002, Vol. 17 Issue 2, p127-130, 4p, 5 Charts – Name: Subject Label: Subject Terms Group: Su Data: <searchLink fieldCode="DE" term="%22Medical+equipment%22">Medical equipment</searchLink><br /><searchLink fieldCode="DE" term="%22Helicobacter+pylori%22">Helicobacter pylori</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: Abstract Background and Aims The CLOtest<superscript>®</superscript> 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. [ABSTRACT FROM AUTHOR] – Name: Abstract Label: Group: Ab Data: <i>Copyright of Journal of Gastroenterology & Hepatology is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
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| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1046/j.1440-1746.2002.02563.x Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 4 StartPage: 127 Subjects: – SubjectFull: Medical equipment Type: general – SubjectFull: Helicobacter pylori Type: general Titles: – TitleFull: Evaluation of a new formulation CLOtest. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: VIIALA, CHARLIE H – PersonEntity: Name: NameFull: WINDSOR, HELEN M – PersonEntity: Name: NameFull: FORBES, GEOFF M – PersonEntity: Name: NameFull: CHAIRMAN, SIMON O – PersonEntity: Name: NameFull: MARSHALL, BARRY J – PersonEntity: Name: NameFull: MOLLISON, LINDSAY C IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 02 Text: Feb2002 Type: published Y: 2002 Identifiers: – Type: issn-print Value: 08159319 Numbering: – Type: volume Value: 17 – Type: issue Value: 2 Titles: – TitleFull: Journal of Gastroenterology & Hepatology Type: main |
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