Dataset Information

Accuracy of faecal occult blood test and Helicobacter pylori stool antigen test for detection of upper gastrointestinal lesions.

ABSTRACT:

Objective

Highly sensitive guaiac-based faecal occult blood (Hemoccult SENSA) and Helicobacter pylori stool antigen testing might help detect upper gastrointestinal lesions when appended to a colorectal cancer screening programme with faecal immunochemical testing. We evaluated the diagnostic accuracies of two stool tests in detecting upper gastrointestinal lesions.

Design

Cross-sectional design.

Setting

Hospital-based and community-based screening settings.

Participants

A hospital-based deviation cohort of 3172 participants to evaluate test performance and a community-based validation cohort of 3621 to verify the findings.

Interventions

Three types of stool tests with bidirectional endoscopy as the reference standard.

Outcomes

Sensitivity, specificity and positive and negative likelihood ratios.

Results

For detecting upper gastrointestinal lesions in cases with negative immunochemical tests, the sensitivity, specificity, and positive and negative likelihood ratios of the guaiac-based and H pylori antigen tests were 16.3% (95% CI 13.3% to 19.8%), 90.1% (88.9% to 91.2%), 1.64 (1.31 to 2.07), and 0.93 (0.89 to 0.97), respectively, and 52.5% (48.1% to 56.9%), 80.6% (79.0% to 82.1%), 2.71 (2.41 to 3.04) and 0.59 (0.54 to 0.65), respectively. For detecting upper gastrointestinal lesions in cases with normal colonoscopy, the results of the guaiac-based and H pylori antigen tests were 17.9% (14.8% to 21.5%), 90.1% (88.9% to 91.2%), 1.81 (1.45 to 2.26) and 0.91 (0.87 to 0.95), respectively, and 53.1% (48.6% to 57.4%), 80.7% (79.1% to 82.2%), 2.75 (2.45 to 3.08) and 0.58 (0.53 to 0.64), respectively. Within the community, positive predictive values of the immunochemical and H pylori antigen tests were 36.0% (26.0% to 46.0%) and 31.9% (28.3% to 35.5%), respectively, for detecting lower and upper gastrointestinal lesions, which were similar to expected values.

Conclusions

The H pylori stool antigen test is more accurate than the guaiac-based test in the screening of upper gastrointestinal lesions in a population with high prevalence of H pylori infection and upper gastrointestinal lesions. It is applicable to add the H pylori antigen test to the immunochemical test for pan detection.

Trial registration

NCT01341197 (ClinicalTrial.gov).

SUBMITTER: Lee YC

PROVIDER: S-EPMC3816242 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Accuracy of faecal occult blood test and Helicobacter pylori stool antigen test for detection of upper gastrointestinal lesions.

Lee Yi-Chia YC Chiu Han-Mo HM Chiang Tsung-Hsien TH Yen Amy Ming-Fang AM Chiu Sherry Yueh-Hsia SY Chen Sam Li-Sheng SL Fann Jean Ching-Yuan JC Yeh Yen-Po YP Liao Chao-Sheng CS Hu Tsung-Hui TH Tu Chia-Hung CH Tseng Ping-Huei PH Chen Chien-Chuan CC Chen Mei-Jyh MJ Liou Jyh-Ming JM Liao Wei-Chih WC Lai Yo-Ping YP Wang Chen-Ping CP Ko Jenq-Yuh JY Wang Hsiu-Po HP Chiang Hung H Lin Jaw-Town JT Chen Hsiu-Hsi HH Wu Ming-Shiang MS

BMJ open 20131030 10

<h4>Objective</h4>Highly sensitive guaiac-based faecal occult blood (Hemoccult SENSA) and Helicobacter pylori stool antigen testing might help detect upper gastrointestinal lesions when appended to a colorectal cancer screening programme with faecal immunochemical testing. We evaluated the diagnostic accuracies of two stool tests in detecting upper gastrointestinal lesions.<h4>Design</h4>Cross-sectional design.<h4>Setting</h4>Hospital-based and community-based screening settings.<h4>Participants ...[more]

PMID: 24176798

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Project description:BACKGROUND: Previous studies have suggested that the immunochemical fecal occult blood test has superior specificity for detecting bleeding in the lower gastrointestinal tract even if bleeding occurs in the upper tract. We conducted a large population-based study involving asymptomatic adults in Taiwan, a population with prevalent upper gastrointestinal lesions, to confirm this claim. METHODS: We conducted a prospective cohort study involving asymptomatic people aged 18 years or more in Taiwan recruited to undergo an immunochemical fecal occult blood test, colonoscopy and esophagogastroduodenoscopy between August 2007 and July 2009. We compared the prevalence of lesions in the lower and upper gastrointestinal tracts between patients with positive and negative fecal test results. We also identified risk factors associated with a false-positive fecal test result. RESULTS: Of the 2796 participants, 397 (14.2%) had a positive fecal test result. The sensitivity of the test for predicting lesions in the lower gastrointestinal tract was 24.3%, the specificity 89.0%, the positive predictive value 41.3%, the negative predictive value 78.7%, the positive likelihood ratio 2.22, the negative likelihood ratio 0.85 and the accuracy 73.4%. The prevalence of lesions in the lower gastrointestinal tract was higher among those with a positive fecal test result than among those with a negative result (41.3% v. 21.3%, p < 0.001). The prevalence of lesions in the upper gastrointestinal tract did not differ significantly between the two groups (20.7% v. 17.5%, p = 0.12). Almost all of the participants found to have colon cancer (27/28, 96.4%) had a positive fecal test result; in contrast, none of the three found to have esophageal or gastric cancer had a positive fecal test result (p < 0.001). Among those with a negative finding on colonoscopy, the risk factors associated with a false-positive fecal test result were use of antiplatelet drugs (adjusted odds ratio [OR] 2.46, 95% confidence interval [CI] 1.21-4.98) and a low hemoglobin concentration (adjusted OR 2.65, 95% CI 1.62-4.33). INTERPRETATION: The immunochemical fecal occult blood test was specific for predicting lesions in the lower gastrointestinal tract. However, the test did not adequately predict lesions in the upper gastrointestinal tract.

Project description:Helicobacter pylori (H. pylori) can cause gastritis, peptic ulcer diseases and gastric carcinoma. Endoscopy as the gold standard method of diagnosis is an invasive procedure that might not be suitable in all scenarios. Therefore, this first study in Jordan aimed to assess the non-invasive 13C urea breath test (UBT) and stool antigen test for diagnosis of H. pylori infection and the successfulness of eradication therapy as alternatives for endoscopy. Hence, a total of 30 patients attending the endoscopy units at Alkarak teaching hospital were asked to complete a questionnaire with demographic and clinical data. They were then tested for H. pylori using 13C UBT and H. pylori stool antigen before having endoscopy. Another 30 patients who were positive for H. pylori by endoscopy were tested using both tests 6 weeks post eradication therapy. Results showed that the rate of H. pylori detection using endoscopy was 56.7% (17/30). Heartburns (82.3%, p value = 0.019), epigastric pain (88.2%, p value = 0.007) and vomiting (70.5%, p value = 0.02) were the most significant symptoms. Family history of peptic ulcer diseases was significantly associated with an increased risk for having a H. pylori positive result (p value = 0.02). Compared to endoscopy, the sensitivity of 13C UBT for the diagnosis of H. pylori was 94.1% (16/17), while it was 76.5% (13/17) for the stool antigen test. The specificity of both tests was equal (76.9%). However, the positive predictive and negative predictive values (84.2% and 90.9%) for 13C UBT were higher than those (81.3% and 71.4%) for the stool antigen test. The accuracy of 13C UBT was 86.7% compared to 76.7% for the stool antigen test. There was an 87% agreement (20 patients out of 23) between both tests when used to assess success of the eradication therapy. In conclusion, the 13C UBT was found to be more sensitive and accurate than the stool antigen test when used for diagnosis; furthermore, it has a comparable outcome to the stool antigen test in assessing the successfulness of the eradication treatment.

Dataset Information

Accuracy of faecal occult blood test and Helicobacter pylori stool antigen test for detection of upper gastrointestinal lesions.

Objective

Design

Setting

Participants

Interventions

Outcomes

Results

Conclusions

Trial registration

Publications

Accuracy of faecal occult blood test and Helicobacter pylori stool antigen test for detection of upper gastrointestinal lesions.

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