Diagnosis of Helicobacter pylori Infection Using Immune – chromatography Tests among Patients Attending Tamboul Hospital in Gazera State

Abstract Helicobacter pylori (H.pylori) causes a major health problem worldwide and more than half of the world population are infected with this pathogen. The diagnosis of infection was initially made through invasive methods but now non- invasive methods were develop to make diagnosis easier. This is cross sectional study was conducted in Tamboul City, Gazira State, during the period from March 2016 to December 2019 to compare between antigens and antibodies tests results used for diagnosis of H. pylori infection among symptomatic and asymptomatic Sudanese patients. The stool and blood samples were collected and analyzed for presence of antigen and antibodies by Immunochromatography (ICT) cards. One hundred (n=100) specimens serum and stool were collected, in which 50 were symptomatic and 50 were asymptomatic patients. In symptomatic patients 18/50 (36%) were males and 32/50 (64%) were females with mean age of 7.61±266. S.D, while in asymptomatic patients 19/50(38%) were males and 31/50(62%) were females with mean age of 7.61±4.66 S.D. In symptomatic patients 35/50 (70%) showed positive results for stool antigen while 30/50(60%) for serum antibodies. In asymptomatic patients 18/50(36%) were positive for stool antigen and 25/50(50%) for serum antibodies. There were significant association between antigen results and patients groups (P.value = 0.001) but there was insignificant association between antibodies results and patients groups (P. value = 0.317). Age groups, history of infected persons in the family, blood group and previous treatment were all not associated with H. pylori infection (P≥0.05). In conclusion, the frequency of H.pylori antigen was higher than antibodies in symptomatic patients, while the frequency of H.pylori antibodies was higher than antigen in asymptomatic patients.

Table of Contents

Subject Page No.

I اآليت

Dedication II

Acknowledgements III

Abstract IV

V المستخلص

Table of Contents VI

List of Tables IX

List of Abbreviation X

CHAPTER I

INTRODUCTION

1.1 Introduction 1

1.2 Rationale 3

1.3 Objectives 4

1.3.1 General Objective 4

1.3.2 Specific Objectives 4

CHAPTER II

LITERATURE REVIEW

2.1 Helicobacter pylori 5

2.1.1 History of H.pylori 5

2.1.2 Cellular morphology 5

2.1.3 Colonial morphology 5

2.1.4 Physiological properties 5

2.1.5 Biochemical characteristic 5

2.1.6 Macromolecular characteristic 6

2.1.7 Antigenic structure and serotype 6

2.1.8 Host range and ecology .

2.1.9 H.pylori genome .

2.1.10 Virulence factors 1

2.1.11 Epidemiology 1

2.1.12 Transmissions of H.pylori infection 1

2.1.13 Signs and symptoms of H.pylori infection 8

2.1.14 Complications of H.pylori infection 8

2.1.15 Immune Response to H.pylori Infection 8

2.1.16 Diagnosis of H.pylori Infection 8

2.1.16.1 Invasive tests 9

2.1.16.1.1 Culture 9

2.1.16.1.2 Rabid urease test (RUT) 9

VIII

2.1.16.1.3 Histopathology 1.

2.1.16.2 Non-Invasive tests 1.

2.1.16.2.1 Urease Breath Test 1.

2.1.16.2.2 Molecular Tests 1.

2.1.16.2.3 Fecal Antigen Test 17

2.1.16.2.4 Serological Tests 17

2.1.16.2.4.1 Enzyme Linked Immune Sorbent Assay (ELISA) 17

2.1.16.2.4.2 ImmunoblottingTechnique 17

2.1.16.4.3 Immunochromatography Test (ICT) 14

2.1.16.5 Gold Standard Technique 14

2.1.17 Treatment of H. pylori Infections 14

2.1.18 Vaccination 13

2.1.19 Prevention 13

2.2 Previous Studies 16

CHAPTER III

MATERAILS AND METHODS

3.1 Study design 75

3.2 Study area 75

3.3 Study duration 75

3.4 Study population 75

3.4.1 Inclusion criteria 75

3.4.2 Exclusion criteria 75

3.5 Ethical consideration 75

3.6 Data collection 75

3.7 Sampling technique 75

3.8 Sample size 75

3.9 Specimen collection and processing 7.

3.9.1 Blood sample 1.

3.9.2 Stool sample 7.

3.10 Laboratory test 7.

3.10.1 Helicobacter pyloriantibodies rapid test 7.

3.10.1.1 Procedure of test 7.

3.10.1.2 Interpretation of results 7.

3.10.2 Helicobacter pylori antigen rapid test 71

3.10.2.1 Procedure of test 71

3.10.2.2 Interpretation of results 71

3.11 Statistical analysis 78

CHAPTER IV

RESULTS

Results 79

CHAPTER V

IX

DISCUSSION, CONCLUSIONSANDRECOMMENDATIONS

5.1 Discussion 43

5.2 Conclusion 43

5.3 Recommendations 44

References 45

Appendices 32