Validity and reliability of faecal antigen test in identifying h. Pylori infection in adults with dyspepsia
Keywords:
Faecal antigen test, h. Pylori infection, validity and reliability
Abstract
Background: H. Pylori is one of underdiagnosed and undertreated in many developing countries, including in India. Faecal antigen test, which is a noninvasive, simple to conduct screening test is reported to be ideal for resource limited settings like India. But the reported validity and reliability of the test is quite variable and studies on the subject in Indian population are scarce.
Objectives: To assess the validity and reliability of faecal antigen test in diagnosis of H. Pylori in adult with dyspepsia.
Materials and methods: The current study is a prospective observational study conducted in a single tertiary care teaching hospital located in south India. Adults between 20 to 49 years, with symptoms of dyspepsia were included. Giemsa staining of Antral mucosal biopsy specimen was considered as gold standard. Faecal antigen test was conducted by ELISA. Sensitivity, specificity, predictive values and reliability (kappa statistic) were assessed.
Results: Faecal antigen positivity was seen in 57 (71.25%) subjects, The Antral mucosal biopsy has given 59(73.8%) positive results, The sensitivity, Specificity of the faecal antigen test were 94.92% (95% CI 89.30 to 100.5%), 95.24% (86.12% to 104.3%) respectively. The positive and negative predictive values were 98.25% (94.83% to 101.6%) and 86.96% (73.19% to 100.7%) respectively. The overall diagnostic accuracy was 95% (90.22% to 99.77%). Reliability as measured by kappa statistic was 0.875 (P value <0.001).
Conclusions: Faecal antigen test has shown good validity and reliability in diagnosis of H. pylori infection.
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References
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29. Andrews J, Marsden B, Brown D, Wong VS, Wood E, Kelsey M. Comparison of three stool antigen tests for Helicobacter pylori detection. Journal of clinical pathology. 2003;56(10):769-71.
30. Segamwenge IL, Kagimu M, Ocama P, Opio K. The utility of the Helicobacter pylori stool antigen test in managing dyspepsia: an experience from a low resource setting. African health sciences. 2014;14(4):829-34, doi.10.4314/ahs.v14i4.9. [PubMed]
31. Shimoyama T. Stool antigen tests for the management of Helicobacter pylori infection. World journal of gastroenterology. 2013;19(45):8188-91, doi.10.3748/wjg.v19.i45.8188. [PubMed]
32. Queiroz DM, Saito M, Rocha GA, Rocha AM, Melo FF, Checkley W, et al. Helicobacter pylori infection in infants and toddlers in South America: concordance between [13C]urea breath test and monoclonal H. pylori stool antigen test. Journal of clinical microbiology. 2013;51(11):3735-40, doi.10.1128/jcm.01752-13. [PubMed]
2. Ghoshal UC, Chaturvedi R, Correa P. The enigma of Helicobacter pylori infection and gastric cancer. Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology. 2010;29(3):95-100, doi.10.1007/s12664-010-0024-1.
3. Ghoshal UC, Chourasia D. Gastroesophageal Reflux Disease and Helicobacter pylori: What May Be the Relationship? J Neurogastroenterol Motil. 2010;16(3):243-50, doi.10.5056/jnm.2010.16.3.243. [PubMed]
4. Katelaris PH, Tippett GH, Norbu P, Lowe DG, Brennan R, Farthing MJ. Dyspepsia, Helicobacter pylori, and peptic ulcer in a randomly selected population in India. Gut. 1992;33(11):1462-6.
5. Romshoo GJ, Malik GM, Basu JA, Bhat MY, Khan AR. Prevalence of Helicobacter pylori Infection in Peptic Ulcer Patients of Highly Endemic Kashmir Valley. Diagnostic and therapeutic endoscopy. 1999;6(1):31-6, doi.10.1155/dte.6.31.
6. Adlekha S, Chadha T, Krishnan P, Sumangala B. Prevalence of helicobacter pylori infection among patients undergoing upper gastrointestinal endoscopy in a medical college hospital in kerala, India. Annals of medical and health sciences research. 2013;3(4):559-63,doi.10.4103/2141-9248.122109.
7. Mujawar P, Nikumbh DB, Suryawanshi KH, Pagare PS, Surana A. Helicobacter pylori Associated Gastritis in Northern Maharashtra, India: A Histopathological Study of Gastric Mucosal Biopsies. Journal of clinical and diagnostic research : JCDR. 2015;9(6):Ec04-6, doi.10.7860/jcdr/2015/13306.6040.
8. Singh K, Ghoshal UC. Causal role of Helicobacter pylori infection in gastric cancer: an Asian enigma. World journal of gastroenterology. 2006;12(9):1346-51.
9. Thirumurthi S, Graham DY. Helicobacter pylori infection in India from a western perspective. The Indian journal of medical research. 2012;136(4):549-62.
10. Miftahussurur M, Yamaoka Y. Diagnostic Methods of Helicobacter pylori Infection for Epidemiological Studies: Critical Importance of Indirect Test Validation. BioMed research international. 2016;2016:4819423, doi.10.1155/2016/4819423.
11. Ricci C, Holton J, Vaira D. Diagnosis of Helicobacter pylori: invasive and non-invasive tests. Best practice & research Clinical gastroenterology. 2007;21(2):299-313, doi.10.1016/j.bpg.2006.11.002.
12. Megraud F. Advantages and disadvantages of current diagnostic tests for the detection of Helicobacter pylori. Scandinavian journal of gastroenterology Supplement. 1996;215:57-62.
13. Iranikhah A, Ghadir MR, Sarkeshikian S, Saneian H, Heiari A, Mahvari M. Stool antigen tests for the detection of Helicobacter pylori in children. Iranian journal of pediatrics. 2013;23(2):138-42. [PubMed]
14. Makristathis A, Pasching E, Schutze K, Wimmer M, Rotter ML, Hirschl AM. Detection of Helicobacter pylori in stool specimens by PCR and antigen enzyme immunoassay. Journal of clinical microbiology. 1998;36(9):2772-4.
15. Calik Z, Karamese M, Acar O, Aksak Karamese S, Dicle Y, Albayrak F, et al. Investigation of Helicobacter pylori antigen in stool samples of patients with upper gastrointestinal complaints. Brazilian journal of microbiology : [publication of the Brazilian Society for Microbiology]. 2016;47(1):167-71, doi.10.1016/j.bjm.2015.11.022.
16. Falsafi T, Lavasani P, Basardeh I, Massarrat S, Landarani Z. Evaluation of an Iranian Home-made Helicobacter pylori Stool Antigen ELISA Kit. Jundishapur journal of microbiology. 2014;7(6):e10629, doi.10.5812/jjm.10629.
17. Gramley WA, Asghar A, Frierson HF, Jr., Powell SM. Detection of Helicobacter pylori DNA in fecal samples from infected individuals. Journal of clinical microbiology. 1999;37(7):2236-40.
18. Guslandi M. Stool immunoassay for Helicobacter pylori is not specific enough. BMJ (Clinical research ed). 2000;320(7248):1541. [PubMed]
19. Karadeniz RS, Ozdegirmenci O, Altay MM, Solaroglu A, Dilbaz S, Hizel N, et al. Helicobacter pylori seropositivity and stool antigen in patients with hyperemesis gravidarum. Infectious diseases in obstetrics and gynecology. 2006;2006:73073, doi.10.1155/idog/2006/73073.
20. Kazemi S, Tavakkoli H, Habizadeh MR, Emami MH. Diagnostic values of Helicobacter pylori diagnostic tests: stool antigen test, urea breath test, rapid urease test, serology and histology. Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences. 2011;16(9):1097-104.
21. Khalifehgholi M, Shamsipour F, Ajhdarkosh H, Ebrahimi Daryani N, Pourmand MR, Hosseini M, et al. Comparison of five diagnostic methods for Helicobacter pylori. Iranian journal of microbiology. 2013;5(4):396-401.
22. Kodama M, Murakami K, Okimoto T, Fukuda Y, Shimoyama T, Okuda M, et al. Influence of proton pump inhibitor treatment on Helicobacter pylori stool antigen test. World journal of gastroenterology. 2012;18(1):44-8, doi.10.3748/wjg.v18.i1.44.
23. Krausse R, Muller G, Doniec M. Evaluation of a rapid new stool antigen test for diagnosis of Helicobacter pylori infection in adult patients. Journal of clinical microbiology. 2008;46(6):2062-5, doi.10.1128/jcm.02387-07.
24. Li YH, Guo H, Zhang PB, Zhao XY, Da SP. Clinical value of Helicobacter pylori stool antigen test, ImmunoCard STAT HpSA, for detecting H pylori infection. World journal of gastroenterology. 2004;10(6):913-4.
25. MacKay WG, Williams CL, McMillan M, Ndip RN, Shepherd AJ, Weaver LT. Evaluation of protocol using gene capture and PCR for detection of Helicobacter pylori DNA in feces. Journal of clinical microbiology. 2003;41(10):4589-93.
26. Malik GM, Kadla S, Mubarik M, Hussain T, Jeelani G, Basu J, et al. Helicobacter pylori infection in endoscopic biopsy specimens of gastric cancer: a preliminary evaluation in a high risk population of kashmir valley. Diagnostic and therapeutic endoscopy. 1997;4(1):35-42, doi.10.1155/dte.4.35.
27. Ganguly M, Sarkar S, Ghosh P, Sarkar A, Alam J, Karmakar BC, et al. Helicobacter pylori plasticity region genes are associated with the gastroduodenal diseases manifestation in India. Gut pathogens. 2016;8:10, doi.10.1186/s13099-016-0093-5.
28. Ghosh P, Sarkar A, Ganguly M, Raghwan, Alam J, De R, et al. Helicobacter pylori strains harboring babA2 from Indian sub population are associated with increased virulence in ex vivo study. Gut pathogens. 2016;8:1, doi.10.1186/s13099-015-0083-z.
29. Andrews J, Marsden B, Brown D, Wong VS, Wood E, Kelsey M. Comparison of three stool antigen tests for Helicobacter pylori detection. Journal of clinical pathology. 2003;56(10):769-71.
30. Segamwenge IL, Kagimu M, Ocama P, Opio K. The utility of the Helicobacter pylori stool antigen test in managing dyspepsia: an experience from a low resource setting. African health sciences. 2014;14(4):829-34, doi.10.4314/ahs.v14i4.9. [PubMed]
31. Shimoyama T. Stool antigen tests for the management of Helicobacter pylori infection. World journal of gastroenterology. 2013;19(45):8188-91, doi.10.3748/wjg.v19.i45.8188. [PubMed]
32. Queiroz DM, Saito M, Rocha GA, Rocha AM, Melo FF, Checkley W, et al. Helicobacter pylori infection in infants and toddlers in South America: concordance between [13C]urea breath test and monoclonal H. pylori stool antigen test. Journal of clinical microbiology. 2013;51(11):3735-40, doi.10.1128/jcm.01752-13. [PubMed]
CITATION
DOI: 10.17511/ijoso.2016.i04.05
Published: 2016-12-31
How to Cite
Kumar, K. S., Kumar, T. D., R, B., & Anantharamakrishnan, R. (2016). Validity and reliability of faecal antigen test in identifying h. Pylori infection in adults with dyspepsia. Surgical Review: International Journal of Surgery, Trauma and Orthopedics, 2(4), 79-84. https://doi.org/10.17511/ijoso.2016.i04.05
Section
Original Article
OAI - Open Archives Initiative
Therapoid
