Validation and value of an enzyme-linked immunosorbent assay for Helicobacter pylori in primary care

N T Lewin-van den Broek; M E Numans; E Buskens; N J de Wit; A J Smout; T J Verheij

doi:10.1080/003655299750026407

Validation and value of an enzyme-linked immunosorbent assay for Helicobacter pylori in primary care

N T Lewin-van den Broek, M E Numans, E Buskens, N J de Wit, A J Smout, T J Verheij

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

BACKGROUND: Helicobacter pylori infection is related to gastric ulcer and carcinoma. In this study we validated the Pyloriset EIA-G New (a quantitative enzyme-linked immunosorbent assay) in a general practice population. The implications of eradication in case of a positive result were assessed.

METHODS: One hundred and fifteen subsequent patients, enrolled in a randomized clinical trial evaluating the optimal strategy for treatment of dyspeptic patients in primary care, were included. Using biopsy as gold standard, we calculated the sensitivity and specificity of the test.

RESULTS: The sensitivity and specificity of the test were 91% (95% confidence interval (CI) = 86% to 97%) and 78% (95% CI = 75% to 82%), respectively. Eradication of H. pylori would be indicated in 8 of 57 positive patients, since these actually had a peptic ulcer. In the other 49 patients eradication therapy would be unnecessary.

CONCLUSION: The Pyloriset EIA-G New is a reliable test in primary care. However, a serologic test-and-treat strategy in all dyspeptic patients cannot be recommended.

Original language	English
Pages (from-to)	391-5
Number of pages	5
Journal	SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY
Volume	34
Issue number	4
DOIs	https://doi.org/10.1080/003655299750026407
Publication status	Published - Apr-1999
Externally published	Yes

Keywords

Adult
Dyspepsia/microbiology
Enzyme-Linked Immunosorbent Assay/methods
Female
Helicobacter Infections/diagnosis
Helicobacter pylori/isolation & purification
Humans
Male
Middle Aged
Primary Health Care
Reproducibility of Results
Sensitivity and Specificity

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title = "Validation and value of an enzyme-linked immunosorbent assay for Helicobacter pylori in primary care",

abstract = "BACKGROUND: Helicobacter pylori infection is related to gastric ulcer and carcinoma. In this study we validated the Pyloriset EIA-G New (a quantitative enzyme-linked immunosorbent assay) in a general practice population. The implications of eradication in case of a positive result were assessed.METHODS: One hundred and fifteen subsequent patients, enrolled in a randomized clinical trial evaluating the optimal strategy for treatment of dyspeptic patients in primary care, were included. Using biopsy as gold standard, we calculated the sensitivity and specificity of the test.RESULTS: The sensitivity and specificity of the test were 91% (95% confidence interval (CI) = 86% to 97%) and 78% (95% CI = 75% to 82%), respectively. Eradication of H. pylori would be indicated in 8 of 57 positive patients, since these actually had a peptic ulcer. In the other 49 patients eradication therapy would be unnecessary.CONCLUSION: The Pyloriset EIA-G New is a reliable test in primary care. However, a serologic test-and-treat strategy in all dyspeptic patients cannot be recommended.",

keywords = "Adult, Dyspepsia/microbiology, Enzyme-Linked Immunosorbent Assay/methods, Female, Helicobacter Infections/diagnosis, Helicobacter pylori/isolation & purification, Humans, Male, Middle Aged, Primary Health Care, Reproducibility of Results, Sensitivity and Specificity",

author = "{Lewin-van den Broek}, {N T} and Numans, {M E} and E Buskens and {de Wit}, {N J} and Smout, {A J} and Verheij, {T J}",

year = "1999",

month = apr,

doi = "10.1080/003655299750026407",

language = "English",

volume = "34",

pages = "391--5",

journal = "SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY",

issn = "0036-5521",

publisher = "Taylor & Francis Group",

number = "4",

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TY - JOUR

T1 - Validation and value of an enzyme-linked immunosorbent assay for Helicobacter pylori in primary care

AU - Lewin-van den Broek, N T

AU - Numans, M E

AU - Buskens, E

AU - de Wit, N J

AU - Smout, A J

AU - Verheij, T J

PY - 1999/4

Y1 - 1999/4

N2 - BACKGROUND: Helicobacter pylori infection is related to gastric ulcer and carcinoma. In this study we validated the Pyloriset EIA-G New (a quantitative enzyme-linked immunosorbent assay) in a general practice population. The implications of eradication in case of a positive result were assessed.METHODS: One hundred and fifteen subsequent patients, enrolled in a randomized clinical trial evaluating the optimal strategy for treatment of dyspeptic patients in primary care, were included. Using biopsy as gold standard, we calculated the sensitivity and specificity of the test.RESULTS: The sensitivity and specificity of the test were 91% (95% confidence interval (CI) = 86% to 97%) and 78% (95% CI = 75% to 82%), respectively. Eradication of H. pylori would be indicated in 8 of 57 positive patients, since these actually had a peptic ulcer. In the other 49 patients eradication therapy would be unnecessary.CONCLUSION: The Pyloriset EIA-G New is a reliable test in primary care. However, a serologic test-and-treat strategy in all dyspeptic patients cannot be recommended.

AB - BACKGROUND: Helicobacter pylori infection is related to gastric ulcer and carcinoma. In this study we validated the Pyloriset EIA-G New (a quantitative enzyme-linked immunosorbent assay) in a general practice population. The implications of eradication in case of a positive result were assessed.METHODS: One hundred and fifteen subsequent patients, enrolled in a randomized clinical trial evaluating the optimal strategy for treatment of dyspeptic patients in primary care, were included. Using biopsy as gold standard, we calculated the sensitivity and specificity of the test.RESULTS: The sensitivity and specificity of the test were 91% (95% confidence interval (CI) = 86% to 97%) and 78% (95% CI = 75% to 82%), respectively. Eradication of H. pylori would be indicated in 8 of 57 positive patients, since these actually had a peptic ulcer. In the other 49 patients eradication therapy would be unnecessary.CONCLUSION: The Pyloriset EIA-G New is a reliable test in primary care. However, a serologic test-and-treat strategy in all dyspeptic patients cannot be recommended.

KW - Adult

KW - Dyspepsia/microbiology

KW - Enzyme-Linked Immunosorbent Assay/methods

KW - Female

KW - Helicobacter Infections/diagnosis

KW - Helicobacter pylori/isolation & purification

KW - Humans

KW - Male

KW - Middle Aged

KW - Primary Health Care

KW - Reproducibility of Results

KW - Sensitivity and Specificity

U2 - 10.1080/003655299750026407

DO - 10.1080/003655299750026407

M3 - Article

C2 - 10365899

SN - 0036-5521

VL - 34

SP - 391

EP - 395

JO - SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY

JF - SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY

IS - 4

ER -

Validation and value of an enzyme-linked immunosorbent assay for Helicobacter pylori in primary care

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