Accuracy of H. pylori fecal antigen test using fecal immunochemical test (FIT)

Abstract Background Gastric and colorectal cancer (CRC) are both one of the most common cancers worldwide. In many countries fecal immunochemical tests (FIT)-based CRC screening has been implemented. We investigated if FIT can also be applied for detection of H. pylori, the main risk factor for gastric cancer. Methods This prospective study included participants over 18 years of age referred for urea breath test (UBT). Patients were excluded if they had used antibiotics/bismuth in the past 4 weeks, or a proton pomp inhibitor (PPI) in the past 2 weeks. Participants underwent UBT, ELISA stool antigen test in standard feces tube (SAT), ELISA stool antigen test in FIT tube (Hp-FIT), and blood sampling, and completed a questionnaire on user friendliness. UBT results were used as reference. Results A total of 182 patients were included (37.4% male, median age 52.4 years (IQR 22.4)). Of these, 60 (33.0%) tested H. pylori positive. SAT and Hp-FIT showed comparable overall accuracy 71.1% (95%CI 63.2–78.3) vs. 77.6% (95%CI 70.4–83.8), respectively (p = 0.97). Sensitivity of SAT was 91.8% (95%CI 80.4–97.7) versus 94.2% (95%CI 84.1–98.9) of Hp-FIT (p = 0.98). Serology scored low with an overall accuracy of 49.7% (95%CI 41.7–57.7). Hp-FIT showed the highest overall user convenience. Conclusions FIT can be used with high accuracy and sensitivity for diagnosis of H. pylori and is rated as the most convenient test. Non-invasive Hp-FIT test is highly promising for combined upper and lower gastrointestinal (pre-) cancerous screening. Further research should investigate the clinical implications, benefits and cost-effectiveness of such an approach.

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The Use of 13C-Urea Breath Test for Non-Invasive Diagnosis of Helicobacter pylori Infection in Comparison to Endoscopy and Stool Antigen Test

Diagnostics ◽

10.3390/diagnostics10070448 ◽

2020 ◽

Vol 10 (7) ◽

pp. 448

Author(s):

Hamed Alzoubi ◽

Asma’a Al-Mnayyis ◽

Ibrahim Al rfoa ◽

Amin Aqel ◽

Mohammad Abu-Lubad ◽

...

Keyword(s):

Breath Test ◽

Eradication Therapy ◽

Urea Breath Test ◽

P Value ◽

Antigen Test ◽

Stool Antigen Test ◽

Non Invasive ◽

Stool Antigen ◽

13C Urea Breath Test ◽

H Pylori

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.

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Evaluation of a stool antigen test using a mAb for native catalase for diagnosis of Helicobacter pylori infection in children and adults

Journal of Medical Microbiology ◽

10.1099/jmm.0.077370-0 ◽

2014 ◽

Vol 63 (12) ◽

pp. 1621-1625 ◽

Cited By ~ 10

Author(s):

Masumi Okuda ◽

Takako Osaki ◽

Shogo Kikuchi ◽

Junko Ueda ◽

Yingsong Lin ◽

...

Keyword(s):

Helicobacter Pylori ◽

Real Time ◽

Real Time Pcr ◽

High Specificity ◽

Antigen Test ◽

Stool Antigen Test ◽

Non Invasive ◽

Significant Difference ◽

Stool Antigen ◽

H Pylori

Non-invasive diagnosis of Helicobacter pylori infection is important not only for screening of infection but also for epidemiological studies. Stool antigen tests are non-invasive and are convenient to identify H. pylori infection, particularly in children. We evaluated the stool antigen test, which uses a mAb for native catalase of H. pylori developed in Japan. A total of 151 stool samples were collected from participants (52 children and 99 adults) of the Sasayama Cohort Study and stored between −30 and −80 °C. The stool antigen test used was Testmate pylori antigen (TPAg), and was performed according to the manufacturer’s instructions. Furthermore, we conducted a quantitative real-time PCR test and compared the PCR results with those of the TPAg test. When compared with the results in real-time PCR, the sensitivity of TPAg was 89.5 % overall, 82.7 % for children and 92.4 % for adults, and the specificity was 100 %. The accuracy was 93.4 % overall, 90.4 % for children and 94.9 % for adults, and there was no significant difference in the accuracy of TPAg between children and adults. Five of 28 children (18 %) and five of 38 adults (13 %) were PCR positive with negative TPAg results. Four of five children with positive PCR and negative TPAg results were given a 13C-urea breath test and all four children tested negative. No significant correlation was observed between the TPAg results and DNA numbers of H. pylori in faeces among children or adults. A stool antigen test (TPAg) using a mAb for native catalase is useful for diagnosis of H. pylori in children and adults. Additionally, this test has particularly high specificity.

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29 P The post-treatment non-invasive diagnosis of H. pylori infection in older subjects comparison of the stool antigen test (HpSA) with the 13C-urea breath test (13C-UBT)

Digestive and Liver Disease ◽

10.1016/s1590-8658(02)90068-x ◽

2002 ◽

Vol 34 ◽

pp. A18

Author(s):

A. Pilotto ◽

M. Franceschi ◽

F. Furlan ◽

L. Bozzola ◽

L. Fucito ◽

...

Keyword(s):

Breath Test ◽

Urea Breath Test ◽

Post Treatment ◽

Antigen Test ◽

Stool Antigen Test ◽

Non Invasive ◽

Stool Antigen ◽

Older Subjects ◽

13C Urea Breath Test ◽

H Pylori

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Efficacy of Different Laboratory Tests to Diagnose Helicobacter pylori Infection

Faridpur Medical College Journal ◽

10.3329/fmcj.v8i1.16890 ◽

2013 ◽

Vol 8 (1) ◽

pp. 11-14 ◽

Cited By ~ 1

Author(s):

MM Shahin Ul Islam ◽

Shamsun Nahar ◽

Mst Naznin Sarker ◽

ASM Salimullah ◽

Mohammad Asadur Rahman ◽

...

Keyword(s):

Helicobacter Pylori ◽

Positive Predictive Value ◽

Negative Predictive Value ◽

Predictive Value ◽

Laboratory Tests ◽

Antigen Test ◽

Stool Antigen Test ◽

Non Invasive ◽

Stool Antigen ◽

H Pylori

Helicobacter pylori is a Gram negative bacteria which causes chronic gastritis, peptic ulcer disease, primary B-cell gastric lymphoma, and adenocarcinoma of the stomach. There are a set of laboratory tests to diagnose H. pylori infection with a variable accuracy, they are divided into non-invasive tests and invasive tests. Non-invasive tests include serology, urea breath test (UBT) and stool antigen test (SAT). Invasive tests include rapid urease test (RUT), histology and culture. This cross sectional study was carried out in the Department of Gastroenterology, Bangabandhu Sheikh Mujib Medical University (BSMMU) and H. pylori laboratory of International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B) from July 2008 to September 2009 to evaluate the efficacy of RUT, SAT and Culture as a diagnostic tool for H. pylori. Dyspeptic patients were collected from outpatient department of BSMMU. Out of 224 dyspeptic patients 149 patients had ulcers or erosions in the stomach or duodenum. Stool sample could be collected from 139 patients. RUT has sensitivity of 100%, specificity 80.28%, positive predictive value 85% and negative predictive value 100%. Regarding culture, sensitivity is 100%, specificity 94.37%, positive predictive value 95% and negative predictive value 100%. Stool antigen test has sensitivity 95.94%, specificity 92.31%,positive predictive value 93% and negative predictive value 95%. DOI: http://dx.doi.org/10.3329/fmcj.v8i1.16890 Faridpur Med. Coll. J. 2013;8(1): 11-14

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Evaluation of Rapid stool antigen test for the diagnosis of Helicobacter pylori infection in patients with dyspepsia

IMC Journal of Medical Science ◽

10.3329/imcjms.v10i2.31108 ◽

2017 ◽

Vol 10 (2) ◽

pp. 39-44

Author(s):

Salma Khatun ◽

Fahmida Rahman ◽

Khandaker Shadia ◽

Indrajit Kumar Dutta ◽

Mohammad Nazmul Hoq ◽

...

Keyword(s):

Helicobacter Pylori ◽

Peptic Ulcer ◽

Helicobacter Pylori Infection ◽

Adult Patients ◽

Antigen Test ◽

Stool Antigen Test ◽

Non Invasive ◽

Stool Antigen ◽

Stool Samples ◽

H Pylori

Background and objectives: Several diagnostic assays are used for the detection of Helicobacter pylori infection in suspected peptic ulcer cases. H. pylori stool antigen test is a non-invasive method for the detection of active infection. The present study has evaluated the efficacy of rapid stool antigen test to diagnose H. pylori infection in patients with dyspepsia.Materials and methods: Adult patients with complains of dyspepsia attending the Department of Gastroenterology, Hepatobiliary and Pancreatic Diseases (GHPD) of BIRDEM hospital for endoscopy were included. Gastric biopsy, blood and stool samples were obtained from each participant after informed written consent. Rapid urease test (RUT), serum H. pylori immunoglobulin A (IgA) and IgG and rapid H. pylori stool antigen (HpSAg) tests were performed. Only stool samples were obtained from 31 neonates aged 1 to 30 days as negative control for HpSAg test.Results: A total of 91 adult patients with complain of dyspepsia were included in the study. Out of 91 cases, 17 (18.7%) and 74 (81.3%) had peptic ulcer and erosion respectively. HpSAg was positive in 63.7% cases compared to 42.9% and 62.6% respectively by RUT and IgA. The rate of HpSAg positivity was significantly higher (p<0.05) in ulcer compared to erosion cases. HpSAg test was positive in all (100%) RUT positive cases. Combination of HpSAg test and IgA yielded highest positive result in both ulcer (82.4%) and erosion (84%) cases. H. pylori IgG was positive in all cases.Conclusion: The study has demonstrated that HpSAg test is an effective and non-invasive diagnostic tool to detect active H. pylori infection in suspected dyspeptic patients.IMC J Med Sci 2016; 10(2): 39-44

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Non-invasive stool antigen test for screening of Helicobacter pylori infection and assessing efficacy of treatment in patients with peptic ulcer

South East Asia Journal of Public Health ◽

10.3329/seajph.v2i1.15262 ◽

2013 ◽

Vol 2 (1) ◽

pp. 28-33

Author(s):

Rezina Karim ◽

SM Moslehuddin Ahmed ◽

Fahmida Begum

Keyword(s):

Helicobacter Pylori ◽

Peptic Ulcer ◽

Helicobacter Pylori Infection ◽

World Population ◽

Antigen Test ◽

Stool Antigen Test ◽

Non Invasive ◽

Stool Antigen ◽

H Pylori ◽

Efficacy Of Treatment

Helicobacter pylori infection is one of the most common infections in humans, with an estimated 50% of the world population being infected. The infection is strongly associated with chronic gastritis, peptic ulcer, adenocarcinoma and non-Hodgkins lymphoma of stomach. The prevalence of infection is high in developing countries, demanding a reliable diagnostic and treatment method. The present study was designed to investigate the monoclonal antibody-based H. Pylori stool antigen test to screen H. pylori infection and assess efficacy of treatment in patients with peptic ulcer. A total of 89 patients who underwent upper gastrointestinal endoscopy from July 2007 to June 2008 at Bangabandhu Sheikh Mujib Medical University Hospital, Dhaka, Bangladesh were included in the study. Endoscopic findings showed that out of 89 patients, 54 (60.7%) had duodenal ulcers, 24 (27%) had antral erosion and 5 (5.6%) had gastric ulcers. With RUT (rapid urease test) and histopathology of biopsy samples of 89 patients, 78 (87.6%) patients were found to be H. pylori positive. Stool antigen test was positive in 72 (92.3%) out of 78 H. pylori positive patients. The monoclonal stool antigen test (SAT) revealed 92.3% sensitivity and specificity of 100% before treatment. Among 52 follow-up patients (after treatment), 5 (9.6%) patients were detected positive by histology, RUT and stool antigen test, and 35 (67.3%) patients were negative by 3 tests. So the monoclonal SAT revealed 100% sensitivity and 100% specificity after treatment. The monoclonal stool antigen test is highly sensitive and a specific tool for diagnosis of H. pylori infection before therapy and can assess the success of eradication after therapy. It also offers the advantage of specificity and reliability over the invasive test. It is easy and quick to use, non-invasive and does not require any special technology.South East Asia J Public Health | Jan-June 2012 | Vol 2 Issue 1 | 28-33 DOI: http://dx.doi.org/10.3329/seajph.v2i1.15262

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