Assessment of a novel method to detect clarithromycin-resistant Helicobacter pylori using a stool antigen test reagent

Abstract Background The resistance rate of Helicobacter pylori to clarithromycin (CAM) is high among infected children in Japan. Therefore, a new method for detecting CAM-resistant H. pylori using a minimally invasive technique is strongly desired. We aimed to investigate the clinical usefulness of our newly developed nested polymerase chain reaction-quenching probe (Nested PCR-QP) method using stool specimens. Methods We first evaluated our method using a residual solution of the H. pylori stool antigen test for adolescents. Then, we evaluated our method using culture testing for adults. Results Among 57 middle school students with H. pylori, the Nested PCR-QP test results of 53 (90.3%) were able to be analyzed. A total of 28 students had CAM resistance mutations. We found a genetic mutation in 28 students and no mutation in 23 students, and these results were consistent with those of PCR-direct sequencing. In the 23 adults who were diagnosed with H. pylori infection using the rapid urease test and culture testing, we were able to use Nested PCR-QP for analyzing 21 adults who tested positive in the stool H. pylori antigen test. The results obtained for all 21 adults were consistent with those obtained via the drug susceptibility test. Conclusions Our novel method could be useful for non-invasively detecting CAM resistance mutations in H. pylori. This may help select a drug to reduce eradication failure rates against H. pylori. Trial registration This study was registered with the University Hospital Medical Information Network Clinical Trials Registry (no. UMIN000030632, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034977) on 29 December 2017.

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Assessment of a novel method to detect clarithromycin-resistant Helicobacter pylori using a stool antigen test reagent

10.21203/rs.2.23000/v1 ◽

2020 ◽

Author(s):

Toshihiko Kakiuchi ◽

Kazutoshi Hashiguchi ◽

Ichiro Imamura ◽

Aiko Nakayama ◽

Ayako Takamori ◽

...

Keyword(s):

Helicobacter Pylori ◽

Nested Pcr ◽

Invasive Technique ◽

Antigen Test ◽

Resistance Mutations ◽

Stool Antigen Test ◽

Urease Test ◽

Stool Antigen ◽

Novel Method ◽

H Pylori

Abstract Background The resistance rate of Helicobacter pylori to clarithromycin (CAM) is high among the infected children in Japan; therefore, a new method for detecting CAM-resistant H. pylori using a less invasive technique is strongly desired. We aimed to confirm the clinical usefulness of our newly developed Nested polymerase chain reaction-QProbe (quenching probe) (Nested PCR-QP) method using stool specimens. Methods The first was an evaluation of our method using the residual solution of the H. pylori stool antigen test for adolescents, and the second was an evaluation of our method using culture testing for adults. Results Of the 57 middle school students with H. pylori , the Nested PCR-QP test results of 53 (90.3%) could be analyzed; 28 students were found to have CAM resistance mutations. The results indicating genetic mutation in 28 and no mutation in 23 students were consistent with those of PCR-direct sequencing. In the 23 adults who were diagnosed with H. pylori infection using the rapid urease test and culture testing, it was possible to use Nested PCR-QP for analyzing all 21 adults who tested positive in the stool H. pylori antigen test. The results obtained for all the 21 adults were consistent with those obtained via the drug susceptibility test. Conclusions Our novel method could be useful for non-invasively detecting CAM resistance mutations in H. pylori. This may help select an eradication drug to reduce eradication failure rates against H. pylori.

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Prospective evaluation of a new stool antigen test for the detection of Helicobacter pylori, in comparison with histology, rapid urease test, 13C-urea breath test, and serology

Journal of Gastroenterology and Hepatology ◽

10.1111/j.1440-1746.2011.06705.x ◽

2011 ◽

Vol 26 (6) ◽

pp. 1053-1059 ◽

Cited By ~ 20

Author(s):

Jeongmin Choi ◽

Chung Hyeon Kim ◽

Donghee Kim ◽

Su Jin Chung ◽

Ji Hyun Song ◽

...

Keyword(s):

Helicobacter Pylori ◽

Breath Test ◽

Urea Breath Test ◽

Rapid Urease Test ◽

Prospective Evaluation ◽

Antigen Test ◽

Stool Antigen Test ◽

Urease Test ◽

Stool Antigen ◽

13C Urea Breath Test

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Investigating the Efficacy of Triple Drug Therapy and Sequential Drug Therapy in the Eradication of Helicobacter Pylori with Respect to Antigen Stool test: A Pilot Study

Kathmandu University Medical Journal ◽

10.3126/kumj.v18i1.33367 ◽

2020 ◽

Vol 18 (1) ◽

pp. 74-83

Author(s):

R. Shrestha ◽

R. Poudel ◽

S. Shakya ◽

R.B. Gurung ◽

R. Makaju ◽

...

Keyword(s):

Helicobacter Pylori ◽

Drug Therapy ◽

Sequential Therapy ◽

Drug Regimen ◽

Epidemiological Studies ◽

Response To Treatment ◽

Antigen Test ◽

Stool Antigen Test ◽

Stool Antigen ◽

H Pylori

Background Helicobacter pylori is one of the most prevalent infectious disease worldwide. The treatment regimens involve mainly two therapies: Standard Triple drug therapy and Sequential drug therapy. Several studies have shown that the sequential therapy has higher eradication rates of H. pylori than the standard triple drug therapy and since proper study on sequential drug therapy and standard triple drug therapy is still lacking in Nepal, this study is attempted to compare efficacy of Sequential Drug Therapy in the eradication of H. pylori in gastritis with respect to the Standard triple drug therapy. Objective To investigate the efficacy of Triple Drug Therapy and Sequential Drug Therapy in the eradication of Helicobacter pylori with respect to Antigen Stool test. Method This study was the prospective study conducted in 62 patients attending the Department of Gastroenterology, Dhulikhel Hospital, meeting the inclusion criteria who were confirmed as H. pylori positive by histopathology and stool antigen test. Patients were randomized into two groups. One group prescribed with Standard triple drug regimen and another group with Sequential drug regimen. Eradication of H. pylori infection was confirmed by repeating the stool antigen test at least five weeks after the completion of the regimen. Result Among the 62 participants included in this study, 54.5% of them were males. Among the study population, the eradication achieved by standard triple drug therapy was 87.8% and 89.6% with Sequential drug therapy. Higher numbers (82.3%) of patients were compliant to the prescribed medication. Forgetfulness was the main reason for missing the dose (91%) of the non-compliant patients. Conclusion The study revealed an equal efficacy of both Standard Triple drug regimen and Sequential drug regimen in the eradication of H. pylori infection. Further, Stool antigen test can be preferred as a non-invasive test, for diagnosis of H. pylori infection, monitoring the response to treatment and in epidemiological studies.

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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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Validation of a rapid stool antigen test for diagnosis of Helicobacter pylori infection

Revista do Instituto de Medicina Tropical de São Paulo ◽

10.1590/s0036-46652010000300002 ◽

2010 ◽

Vol 52 (3) ◽

pp. 125-128 ◽

Cited By ~ 12

Author(s):

Joyce Matie Kinoshita da Silva ◽

Cibele Aparecida Villares ◽

Maria do Socorro Monteiro ◽

Carlos Colaúto ◽

Anibal Ferreira dos Santos ◽

...

Keyword(s):

Helicobacter Pylori ◽

Breath Test ◽

False Negative ◽

Lateral Flow ◽

Antigen Test ◽

Kappa Index ◽

Stool Antigen Test ◽

Infection Diagnosis ◽

Stool Antigen ◽

H Pylori

The aim of this study was to validate the rapid lateral flow Helicobacter pylori stool antigen test (One step H. pylori antigen test, ACON laboratories, San Diego, USA; Prime diagnostics, São Paulo), using 13C-Urea Breath Test as the gold standard for H. pylori infection diagnosis. A total of 98 consecutive patients, asymptomatic or dyspeptic, entered the study. Sixty-nine were women, with a mean age of 45.76 ± 14.59 years (14 to 79 years). In the H. pylori-positive group, the rapid stool antigen test detected H. pylori antigen in 44 of the 50 positive patients (sensitivity 88%; 95% CI: 75.7-95.5%), and six false-negative; and in the H. pylori-negative group 42 presented negative results (specificity 87.5%; 95% CI: 74.7-95.3%), and six false-positive, showing a substantial agreement (Kappa Index = 0.75; p < 0.0001; 95% CI: 0.6-0.9). Forty four of fifty patients that had positive stool antigen were H. pylori-positive, the PPV of the stool antigen test was 88% (95% CI: 75.7-95.5%), and 42 patients with negative stool antigen test were H. pylori-negative, the NPV of the stool antigen test was 87.5% (95% CI: 74.7-95.3%). We conclude that the lateral flow stool antigen test can be used as an alternative to breath test for H. pylori infection diagnosis especially in developing countries.

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