Noninvasive antigen-based assay for assessing Helicobacter pylori eradication: a European multicenter study

Vaira, Dino; Malfertheiner, Peter; Mégraud, Françis; At, Axon; Deltenre, M.; Gasbarrini, Giovanni; OʼMorain, C; Jm, Pajares García; Quina, M; Gn, Tytgat

doi:10.1111/j.1572-0241.2000.01931.x

Cited by 100 publications

(70 citation statements)

References 11 publications

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“…6 We have also used the same cut-off values of optical density as were adopted by the authors of the largest European study performed to monitor eradication therapy. 23 In the light of this, it is difficult to understand the discrepancy between the results of this European study and ours. It must be taken into account, however, that the former was a multicentre study, whereas our investigation was conducted in a single centre.…”

Section: Discussioncontrasting

confidence: 50%

“…Although some investigators have demonstrated that UBT and HpSA are absolutely equivalent in terms of sensitivity and specificity in the evaluation of eradication therapy, 15,23,24 others have documented a lower than expected reliability of HpSA in this setting. [25][26][27][28][29] It has been rightly emphasized that many studies on the performance of HpSA in post-treatment assessment have used UBT as the gold standard, and this has certainly diminished the meaning of the results.…”

Section: Discussionmentioning

confidence: 99%

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Stool antigen assay (HpSA) is less reliable than urea breath test for post‐treatment diagnosis of Helicobacter pylori infection

Bilardi¹,

Biagini²,

Dulbecco³

et al. 2002

Aliment Pharmacol Ther

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Section: Discussioncontrasting

confidence: 50%

Section: Discussionmentioning

confidence: 99%

Stool antigen assay (HpSA) is less reliable than urea breath test for post‐treatment diagnosis of Helicobacter pylori infection

Bilardi¹,

Biagini²,

Dulbecco³

et al. 2002

Aliment Pharmacol Ther

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“…Positive and negative control wells did not initially reveal spectrophotometric reading within expected ranges; the problem was corrected by rinsing the wells seven times instead of four times between steps, a modification recommended by the manufacturer. Some investigators have deemed HpSA optical density (OD) values above 0.160 to be positive, values between 0.140 and 0.159 to be indeterminate, and values below 0.140 to be negative (27). We considered values equal to or above 0.140 to be positive in accordance with a calculated optimal cutoff point (see below).…”

Section: Methodsmentioning

confidence: 99%

“…Several studies have recently shown that the Premier Platinum H. pylori stool antigen test kit (HpSA) (Meridian Diagnostics, Inc) is comparable to other noninvasive tests for initial diagnosis of H. pylori infection (2,4,11,12,13,26,28). For monitoring the efficacy of eradication treatment, however, the results have been equivocal (11,13,26,27,28). By comparing HpSA test results to endoscopy and UBT findings, we attempted to confirm the validity of HpSA for diagnosis and to establish the long-term posttreatment follow-up in patients in a developing country where there is a very high prevalence of H. pylori infection.…”

mentioning

confidence: 99%

Posttreatment Follow-Up of Helicobacter pylori Infection Using a Stool Antigen Immunoassay

Roth

Taylor

Gilman

et al. 2001

Clin Diagn Lab Immunol

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The Helicobacter pylori stool antigen enzyme immunoassay (HpSA) was evaluated during posttreatment follow-up of patients in a country with a very high prevalence of H. pylori infection. From among 273 dyspeptic individuals (18 to 55 years) initially recruited from a shantytown in Lima, Peru, 238 participants who met the inclusion criteria and were suspected to be H. pylori positive based on 14 C urea breath test (UBT) results underwent endoscopy. Participants with endoscopy-proven infections received standard eradication therapy and were monitored by UBT and HpSA at 1 month following treatment and at 3-month intervals for 9 months posttreatment. A second endoscopy was performed if UBT results showed evidence of treatment failure or H. pylori recurrence. Biopsy results were considered the "gold standard" in all analyses. Among patients who underwent endoscopy, HpSA had a pretreatment sensitivity of 93%. Two-hundred thirty patients completed the treatment regimen, of whom 201 (93%) were considered to have had successful treatment outcomes based on a negative follow-up UBT. Thirty-two patients with UBT-defined treatment failures or H. pylori recurrences at any point during the 9-month follow-up underwent a second endoscopy. In the posttreatment setting, HpSA had an overall sensitivity of 73% and a specificity of 67%. Agreement between UBT and HpSA diminished throughout the follow-up. Among 14 participants in whom HpSA remained positive at 1 month following treatment despite UBT evidence of treatment success, 12 (86%) became HpSA negative within 3 months posttreatment. Although this study confirmed the validity of the HpSA in the initial assessment of dyspeptic patients, the test demonstrated a reduced overall accuracy in the detection of treatment failures and H. pylori recurrences during 9 months of posttreatment follow-up. Furthermore, in some patients it may take up to 3 months after successful eradication for antigen shedding to diminish to levels within the negative HpSA range.Helicobacter pylori was first linked with gastritis in 1975 and was subsequently shown to be associated with peptic ulcer in 1985. Since then, the detection of the spiral bacterium in the gastric mucosa has become a principal aspect of the diagnostic investigation of patients with upper gastrointestinal symptoms suggestive of peptic ulcer disease (7). Chronic superficial gastritis due to infection with H. pylori is responsible for up to 95% of duodenal ulcers and 80% of gastric ulcers throughout the world (25). Perhaps the most convincing evidence for the pathogenic role of H. pylori is the dramatic effect of antibiotic therapy. Current treatment regimens combining at least two antibiotics and a proton pump inhibitor can eradicate H. pylori infections in greater than 90% of patients (21), and they significantly reduced ulcer recurrence in long-term follow-up studies (29). The organism has also been classified as a class I carcinogen due to its pathogenic role in intestinal-type gastric adenocarcinoma and has further been linked to diffus...

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“…In that case, only highly accurate tests (with very high specificity) are acceptable and serology will soon not be suitable anymore. Urea breath tests 231 232 and stool antigen tests [233][234][235] may be valuable alternatives. Screening for H pylori will provide one of two possibilities: a positive test result or a negative test result.…”

Section: Rationale and Limitations Of The Various Approaches Of The Dmentioning

confidence: 99%

A rational approach to uninvestigated dyspepsia in primary care: review of the literature

Arents

Thijs

Kleibeuker

2002

Postgraduate Medical Journal

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In this paper the rationale and limitations of the four most important approach strategies to dyspepsia in primary care (empiric treatment, prompt endoscopy, “test-and-scope”, and “test-and-treat”) are analysed. It is concluded that in the absence of alarm symptoms, a “test-and-treat” approach is currently the most rational approach provided that three conditions are met: (1) a highly accurate test should be used, (2) the prevalence of Helicobacter pylori in the population should not be too low, and (3) an effective anti-H pylori regimen should be prescribed taking sufficient time to instruct and motivate the patient.

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Noninvasive antigen-based assay for assessing Helicobacter pylori eradication: a European multicenter study

Abstract: HpSA has proven to be a useful method in posttreatment eradication testing for H. pylori. Its ease of use, speed, and noninvasive nature make HpSA testing an ideal method for post-treatment monitoring where a second EGD may not be justified.

Cited by 100 publications

References 11 publications

Stool antigen assay (HpSA) is less reliable than urea breath test for post‐treatment diagnosis of Helicobacter pylori infection

Stool antigen assay (HpSA) is less reliable than urea breath test for post‐treatment diagnosis of Helicobacter pylori infection

Posttreatment Follow-Up of Helicobacter pylori Infection Using a Stool Antigen Immunoassay

A rational approach to uninvestigated dyspepsia in primary care: review of the literature

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