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

Yi-Chia Lee, Han-Mo Chiu, Tsung-Hsien Chiang, Amy Ming-Fang Yen, Sherry Yueh-Hsia Chiu, Sam Li-Sheng Chen, Jean Ching-Yuan Fann, Yen-Po Yeh, Chao-Sheng Liao, Tsung-Hui Hu, Chia-Hung Tu, Ping-Huei Tseng, Chien-Chuan Chen, Mei-Jyh Chen, Jyh-Ming Liou, Wei-Chih Liao, Yo-Ping Lai, Chen-Ping Wang, Jenq-Yuh Ko, Hsiu-Po Wang, Hung Chiang, Jaw-Town Lin, Hsiu-Hsi Chen, Ming-Shiang Wu, Yi-Chia Lee, Han-Mo Chiu, Tsung-Hsien Chiang, Amy Ming-Fang Yen, Sherry Yueh-Hsia Chiu, Sam Li-Sheng Chen, Jean Ching-Yuan Fann, Yen-Po Yeh, Chao-Sheng Liao, Tsung-Hui Hu, Chia-Hung Tu, Ping-Huei Tseng, Chien-Chuan Chen, Mei-Jyh Chen, Jyh-Ming Liou, Wei-Chih Liao, Yo-Ping Lai, Chen-Ping Wang, Jenq-Yuh Ko, Hsiu-Po Wang, Hung Chiang, Jaw-Town Lin, Hsiu-Hsi Chen, Ming-Shiang Wu

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).

Keywords: GASTROENTEROLOGY.

Figures

Figure 1
Figure 1
Flow diagram of enrolment. EGD, esophagogastroduodenoscopy; FIT, faecal immunochemical test; gFOBT, guaiac-based faecal occult blood test; HPSA, Helicobacter pylori stool antigen test.;
Figure 2
Figure 2
Flow diagram for the screening using the guaiac-based occult blood test and the faecal immunochemical test according to the Standards for Reporting of Diagnostic Accuracy statement in the hospital-based deviation cohort.
Figure 3
Figure 3
Flow diagram for the screening using the Helicobacter pylori stool antigen test and the faecal immunochemical test according to the Standards for Reporting of Diagnostic Accuracy statement in the hospital-based deviation cohort.

References

    1. Ferlay J, Shin HR, Bray F, et al. Globocan 2008 v2.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10 [Internet]. Lyon, France: International Agency for Research on Cancer, 2010. (accessed 10 Oct 2012)
    1. Bloom DE, Cafiero ET, Jané-Llopis E, et al. The Global Economic Burden of noncommunicable diseases. Geneva: World Economic Forum, 2011
    1. Smith RA, Cokkinides V, Brawley OW. Cancer screening in the United States, 2009: a review of current American Cancer Society guidelines and issues in cancer screening. CA Cancer J Clin 2009;59:27–41 Review.
    1. Chen TH, Chiu YH, Luh DL, et al. Taiwan Community-Based Integrated Screening Group Community-based multiple screening model: design, implementation, and analysis of 42,387 participants. Cancer 2004;100:1734–43
    1. Shaukat A, Mongin SJ, Geisser MS, et al. Long-term mortality after screening for colorectal cancer. N Engl J Med 2013;369: 1106–14
    1. Chiang TH, Lee YC, Tu CH, et al. Performance of the immunochemical fecal occult blood test in predicting lesions in the lower gastrointestinal tract. CMAJ 2011;183:1474–81
    1. Rockey DC. Occult gastrointestinal bleeding. N Engl J Med 1999;341:38–46 Review.
    1. Rockey DC, Auslander A, Greenberg PD. Detection of upper gastrointestinal blood with fecal occult blood tests. Am J Gastroenterol 1999;94:344–50
    1. Young GP, Bosch LJ. Fecal tests: from blood to molecular markers. Curr Colorectal Cancer Rep 2011;7:62–70
    1. Malfertheiner P, Megraud F, O'Morain CA, et al. European Helicobacter Study Group. Management of Helicobacter pylori infection—the Maastricht IV/ Florence Consensus Report. Gut 2012;61:646–64
    1. Bosman FT, Carneiro F, Hruban RH, et al. eds. WHO classification of tumours of the digestive system. Lyon: IARC, 2010
    1. Cancer Control and Prevention Health Promotion Administration, Ministry of Health and Welfare. Taiwan, ROC: (accessed 25 Jul 2013)
    1. Lee YC, Tseng PH, Liou JM, et al. Performance of a one-step fecal sample-based test for diagnosis of Helicobacter pylori infection in primary care and mass screening settings. J Formos Med Assoc [Epub ahead of print].
    1. Chen LS, Liao CS, Chang SH, et al. Cost-effectiveness analysis for determining optimal cut-off of immunochemical faecal occult blood test for population-based colorectal cancer screening (kcis 16). J Med Screen 2007;14:191–9
    1. Chiu HM, Lin JT, Lee YC, et al. Different bowel preparation schedule leads to different diagnostic yield of proximal and nonpolypoid colorectal neoplasm at screening colonoscopy in average-risk population. Dis Colon Rectum 2011;54:1570–7
    1. Rockey DC, Koch J, Cello JP, et al. Relative frequency of upper gastrointestinal and colonic lesions in patients with positive fecal occult-blood tests. N Engl J Med 1998;339:153–9
    1. Lundell LR, Dent J, Bennett JR, et al. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut 1999;45:172–80
    1. Tajiri T, Yoshida H, Obara K, et al. General rules for recording endoscopic findings of esophagogastric varices (2nd edition). Dig Endosc 2010;22:1–9
    1. Benson VS, Atkin WS, Green J, et al. International colorectal cancer screening network. Toward standardizing and reporting colorectal cancer screening indicators on an international level: the international colorectal cancer screening network. Int J Cancer 2012;130:2961–73
    1. Allison JE, Tekawa IS, Ransom LJ, et al. A comparison of fecal occult-blood tests for colorectal-cancer screening. N Engl J Med 1996;334:155–9
    1. Greenberg PD, Bertario L, Gnauck R, et al. A prospective multicenter evaluation of new fecal occult blood tests in patients undergoing colonoscopy. Am J Gastroenterol 2000;95:1331–8
    1. Edge SB, Byrd DR, Carducci MA, et al. eds. American Joint Committee on Cancer (AJCC) Cancer Staging Manual. 7th edn New York: Springer, 2009
    1. Altman DG, Bland JM. Diagnostic tests 2: predictive values. BMJ 1994;309:102.
    1. Vecchio TJ. Predictive value of a single diagnostic test in unselected populations. N Engl J Med 1966;274:1171–3
    1. Gisbert JP, de la Morena F, Abraira V. Accuracy of monoclonal stool antigen test for the diagnosis of H. pylori infection: a systematic review and meta-analysis. Am J Gastroenterol 2006;101:1921–30
    1. Clarke-Pearson DL. Clinical practice. Screening for ovarian cancer. N Engl J Med 2009;361:170–7 Review.
    1. Tseng PH, Lee YC, Chiu HM, et al. Association of diabetes and HbA1c levels with gastrointestinal manifestations. Diabetes Care 2012;35:1053–60
    1. Chiu HM, Lee YC, Tu CH, et al. Association between early-stage colon neoplasms and false-negative results from the fecal immunochemical test. Clin Gastroenterol Hepatol 2013;11:832–8
    1. Cancer Statistics. Taiwan Cancer Registry. (accessed 21 Nov 2012)
    1. Allard J, Cosby R, Del Giudice ME, et al. Gastroscopy following a positive fecal occult blood test and negative colonoscopy: systematic review and guideline. Can J Gastroenterol 2010;24:113–20
    1. Thomas WM, Hardcastle JD. Role of upper gastrointestinal investigation in a screening study for colorectal neoplasia. Gut 1990;31:1294–7
    1. de Martel C, Ferlay J, Franceschi S, et al. Global burden of cancers attributable to infections in 2008: a review and synthetic analysis. Lancet Oncol 2012;13:607–15
    1. Lee YC, Lin JT, Wu HM, et al. Cost-effectiveness analysis between primary and secondary preventive strategies for gastric cancer. Cancer Epidemiol Biomarkers Prev 2007;16:875–85
    1. Lee YC, Chen TH, Chiu HM, et al. The benefit of mass eradication of Helicobacter pylori infection: a community-based study of gastric cancer prevention. Gut 2013;62:676–82
    1. Greenberg ER, Anderson GL, Morgan DR, et al. 14-day triple, 5-day concomitant, and 10-day sequential therapies for Helicobacter pylori infection in seven Latin American sites: a randomised trial. Lancet 2011;378:507–14
    1. Liou JM, Chen CC, Chen MJ, et al. Taiwan Helicobacter Consortium Sequential versus triple therapy for the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial. Lancet 2013;381:205–13
    1. Shiotani A, Cen P, Graham DY. Eradication of gastric cancer is now both possible and practical. Semin Cancer Biol 2013. doi:pii: S1044-579X(13)00066-7. 10.1016/j.semcancer.2013.07.004. [Epub ahead of print].
    1. Wong BC, Lam SK, Wong WM, et al. ; China Gastric Cancer Study Group Helicobacter pylori eradication to prevent gastric cancer in a high-risk region of China: a randomized controlled trial. JAMA 2004;291:187–94
    1. Chan FK, Chung SC, Suen BY, et al. Preventing recurrent upper gastrointestinal bleeding in patients with Helicobacter pylori infection who are taking low-dose aspirin or naproxen. N Engl J Med 2001;344:967–73
    1. Aro P, Storskrubb T, Ronkainen J, et al. Peptic ulcer disease in a general adult population: the Kalixanda study: a random population-based study. Am J Epidemiol 2006;163:1025–34
    1. Sung JJ, Kuipers EJ, El-Serag HB. Systematic review: the global incidence and prevalence of peptic ulcer disease. Aliment Pharmacol Ther 2009;29:938–46
    1. Wang AY, Peura DA. The prevalence and incidence of Helicobacter pylori-associated peptic ulcer disease and upper gastrointestinal bleeding throughout the world. Gastrointest Endosc Clin N Am 2011;21:613–35
    1. World Gastroenterology Organisation World Gastroenterology Organisation Global Guideline: Helicobacter pylori in developing countries. J Clin Gastroenterol 2011;45:383–8
    1. Musumba C, Jorgensen A, Sutton L, et al. The relative contribution of NSAIDs and Helicobacter pylori to the aetiology of endoscopically-diagnosed peptic ulcer disease: observations from a tertiary referral hospital in the UK between 2005 and 2010. Aliment Pharmacol Ther 2012;36:48–56
    1. Sánchez-Delgado J, Gené E, Suárez D, et al. Has H. pylori prevalence in bleeding peptic ulcer been underestimated? A meta-regression. Am J Gastroenterol 2011;106:398–405
    1. Goss PE, Lee BL, Badovinac-Crnjevic T, et al. Planning cancer control in Latin America and the Caribbean. Lancet Oncol 2013;14:391–436
    1. Dutta AK, Chacko A, Balekuduru A, et al. Time trends in epidemiology of peptic ulcer disease in India over two decades. Indian J Gastroenterol 2012;31:111–15
    1. Agha A, Graham DY. Evidence-based examination of the African enigma in relation to Helicobacter pylori infection. Scand J Gastroenterol 2005;40:523–9
    1. Annibale B, Capurso G, Baccini F, et al. Role of small bowel investigation in iron deficiency anaemia after negative endoscopic/histologic evaluation of the upper and lower gastrointestinal tract. Dig Liver Dis 2003;35:784–7
    1. Harewood GC, McConnell JP, Harrington JJ, et al. Detection of occult upper gastrointestinal tract bleeding: performance differences in fecal occult blood tests. Mayo Clin Proc 2002;77: 23–8
    1. Nagasaka T, Tanaka N, Cullings HM, et al. Analysis of fecal DNA methylation to detect gastrointestinal neoplasia. J Natl Cancer Inst 2009;101:1244–58
    1. Ahlquist DA. Next-generation stool DNA testing: expanding the scope. Gastroenterology 2009;136:2068–73
    1. Asaka M, Kato M, Graham DY. Strategy for eliminating gastric cancer in Japan. Helicobacter 2010;15:486–90

Source: PubMed

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