“…Even before preselection, however, the prevalence of infection was 92% based on UBT. Employing biopsy results (rapid urease, histology, or culture) as the gold standard, the sensitivity of HpSA in this pre selected population prior to treatment was 93%, a finding within the range of previous studies (89 to 96%) (2,4,11,12,13,26,27,28). It should be noted that all but 3 of the 235 patients considered to be H. pylori positive by our study criteria are also considered according to published recommendations requiring at least two positive biopsy-based tests or positive culture alone (8).…”
Section: Discussionsupporting
confidence: 75%
“…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).…”
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...
“…Even before preselection, however, the prevalence of infection was 92% based on UBT. Employing biopsy results (rapid urease, histology, or culture) as the gold standard, the sensitivity of HpSA in this pre selected population prior to treatment was 93%, a finding within the range of previous studies (89 to 96%) (2,4,11,12,13,26,27,28). It should be noted that all but 3 of the 235 patients considered to be H. pylori positive by our study criteria are also considered according to published recommendations requiring at least two positive biopsy-based tests or positive culture alone (8).…”
Section: Discussionsupporting
confidence: 75%
“…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).…”
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...
“…The diagnostic accuracy of HpSA is also comparable (sensitivity 92.6%, specificity 100%) with that of other diagnostic tests (14,19,20). The HpSA test has already been used in a few studies to monitor the efficacy of eradication therapy (21)(22)(23).…”
These results should stimulate additional research into the involvement of H. pylori infection in chronic ITP in childhood. This approach may offer an accepted algorithm at least for some of these patients.
“…Analysis of results reported in the different studies give weighted mean values of 93.6% and 94.2% and 92% and 92.2% for sensitivity and specificity pre‐ and post‐treatment, respectively ( Table 7,8). 84–95 …”
Summary
There are two general ways in which a diagnosis of infection by Helicobacter pylori can be made: by using either an invasive or non‐invasive procedure. The invasive procedures involve an endoscopy and biopsy. A biopsy is essential because often the mucosa may appear macroscopically normal but nevertheless be inflamed. A biopsy is obtained by histological examination, culture, polymerase chain reaction or detection of the presence of urease activity in biopsy material.
The non‐invasive tests that can be used to diagnose the infection are serology, detection of labelled metabolic products of urea hydrolysis in the breath (13CO2, 14CO2), the urine or the blood, and detection of H, pylori antigen in a stool specimen. At present no single test can be relied upon to detect definitely colonization by H. pylori, and a combination of two is recommended if this is feasible. The choice of the test to be used is not straightforward and may vary according to the clinical condition and local expertise.
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