วิธีลาแทกซ์แอกกลูติเนชันอิมมูโนแอสเสย์และวิธีอิมมูโนโครมาโตกราฟฟีสำหรับการตรวจคัดกรองภาวะเลือดออกในทางเดินอาหาร
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Published:
Apr 6, 2018
Keywords:
agglutination immunoassay immunchromatography bleeding gastrointestinal tract
Main Article Content
Abstract
The latex agglutination immunoassay is a diagnostic technique for the determination of gastrointestinal bleeding disorder through the investigation of hemoglobin (Hb) concentration (conc.). This differs from the immunochromatography (IC) method which requires the observation of band patterns on a test pad to determine negative or positive results. The research objective is to investigate suitable Hb conc. in fecal samples to indicate positive and negative results in latex agglutination immunoassay through the comparison of results with the IC method. The study was conducted using 116 fecal specimens from patients who attended Thammasat University Hospital, Pathum Thani province. ROC curve and Chi-square test were used to explore the appropriate Hb conc. and association analysis with IC method. The result illustrated the most appropriate cut-off of Hb conc. at 41 nanogram per milliliter (ng/ml) which provided percent of sensitivity, specificity and correctly classified are 95.45, 72.00 and 85.34 % respectively. Moreover, this Hb conc. provides power of discrimination of 91.91, within confidence interval of 87.00 to 97.00 %. These results can be considered as outstanding. In conclusion, the study revealed that the cut-off Hb. conc. at 41 ng/mL in latex agglutination immunoassay provides the best percentage of sensitivity and good specificity when compared with IC method. Although, erythrocyte count by light microscope is not related to IC method, average count is significantly different between positive and negative results in IC method. The aim of future research should be to evaluate latex agglutination immunoassay combined with other factors in order to improve efficiency of screening diseases.
Keywords: agglutination; immunoassay; immunchromatography; bleeding; gastrointestinal tract
Article Details
Section
Medical Sciences
References
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[27] Ahlquist, D.A., Skoletsky, J.E. and Boynton, K.A., 2000, Colorectal cancer screening by detection of altered human DNA in stool: Feasibility of a multi target assay panel, Gastroenterology 119: 1219-1227.
[28] Elsafi, S.H., Alqahtani, N.I., Zakary, N.Y. and Al Zahrani, E.M., 2015, The sensitivity, specificity, predictive values, and likelihood ratios of fecal occult blood test for the detection of colorectal cancer in hospital settings, Clin. Exp. Gastroenterol. 8: 279-284.
[29] Faivre, J., Dancourt, V. and Lejeune, C., 2012, Screening for colorectal cancer with immunochemical faecal occult blood tests, Dig. Liver Dis. 44: 967- 973.
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[31] Rozen, P., Comaneshter, D. and Levi, Z., 2010, Cumulative evaluation of a quanti-tative immunochemical fecal occult blood test to determine its optimal clinical use, Cancer 116: 2115-2125.
[32] Young, G.P., Symonds, E.L., Allison, J.E., Cole, S.R., Fraser, C.G. and Halloran, S.P., 2015, Advances in fecal occult blood tests: The FIT revolution, Dig. Dis. Sci. 60: 609-622.
[33] McDonald, P.J., Strachan, J.A, Digby, J., Steele, R.J. and Fraser, C.G., 2011, Faecal haemoglobin concentrations by gender and age: Implications for population-based screening for colorectal cancer, Clin. Chem. Lab. Med. 50: 935-940.
[34] Turenhout, S.T., Oort, F.A., Hulst, R.W.M., Visscher, A.P., Droste, J.S.T. and Scholten, P., 2014, Prospective cross-sectional study on faecal immunochemical tests: Sex specific cut-off values to obtain equal sensitivity for colorectal cancer?, BMC. Gastroenterol. 14: 1-10.
[35] Stegeman, I., de Wijkerslooth, T.R. and Stoop, E.M., 2014, Combining risk factors with faecal immunochemical test outcome for selecting CRC screenees for colonoscopy, Gut 63: 466-471.
[36] Guittet, L., Guillaume, E., Levillain, R., et al., 2011, Analytical comparison of three quantitative immunochemical fecal occult blood tests for colorectal cancer screening, Cancer Epidemiol. Biomarkers Prev. 20: 1492-1501.
[37] van Rossum, L.G., van Rijn, A.F., van Oijen, M.G., et al., 2009, False negative fecal occult blood tests due to delayed sample return in colorectal cancer screening, Int. J. Cancer 125: 746-750.
[38] van Roon, A.H., Hol, L. and van Vuuren, A.J. and van Leerdam, M., 2012, Are fecal immunochemical test characteristics influ-enced by sample return time? A population-based colorectal cancer screening trial, Am. J. Gastroenterol. 107: 99-107.
[2] Daly, J.M., Bay, C.P. and Levy, B.T., 2013, Evaluation of fecal Immunochemical tests for CRC screening, J. Prim Care Commun. Health 4: 1-4
[3] Ferlay, J., Soerjomataram, I., Ervik, M., Dikshit, R., Eser, S., Mathers, C., Parkin, D.M., Forman, D., Bray, F., 2015, Cancer incidence and mortality worldwide: Sources, methods and major patterns in GLOBOCAN 2012, Int. J. Cancer 136: E359-386.
[4] Khuhaprema, T. and Srivatanakul, P., 2008, Colon and rectum cancer in Thailand: An overview, Jpn. J. Clin. Oncol. 38: 237-243.
[5] Massat, N.J., Moss, S.M. and Halloran, S.P., 2013, Screening and primary prevention of colorectal cancer: A review of sex-specific and site-specific differences, J. Med. Screen. 20: 125-148.
[6] Lohsiriwat, V., 2014, Accuracy of self-checked fecal occult blood testing for colorectal cancer in Thai patients, APJCP. 15: 7981-7984.
[7] Whitlock, E.P., Lin J.S., Liles, E., Beil, T.L. and Fu, R., 2008, Screening for colorectal cancer: A targeted, up dated systematic review for the U.S. preventive services Task Force, Ann. Int. Med. 149: 638-658.
[8] Allison, J.E., Fraser, C.G., Halloran, S.P. and Young, G.P., 2014, Population screening for colorectal cancer means getting FIT: The past, present, and future of colorectal cancer screening using the fecal immunochemical test for hemoglobin (FIT), Gut Liver 8: 117-130.
[9] Macrae, F.A. and St John, D.J., 1982, Relationship between patterns of bleeding and hemoccult sensitivity in patients with colorectal cancers or adenomas, Gastroenterology 82: 891-898.
[10] Hernandez, V., Cubiella, J., Gonzalez-Mao, M.C., et al., 2014, COLONPREV study investigators fecal immunochemical test accuracy in average-risk colorec¬tal cancer screening, World J. Gastroenterol. 20: 1038-1047.
[11] Stracci, F., Zorzi, M. and Grazzini G., 2014, Colorectal cancer screening: Tests, strategies, and perspectives, Front. Public Health 2: 210.
[12] Quintero, E., Castells, A., Bujanda, L., et al., 2012, Colonoscopy versus fecal immune-chemical testing incolorectal-cancer screening, N. Engl. J. Med. 366: 697-706.
[13] Lohsiriwat, V., Thavichaigarn, P. and Awapittaya, B.A., 2007, Multicenter prospective study of immunochemical fecal occult blood testing for colorectal cancer detection, J. Med. Assoc. Thai 90: 2291-2295.
[14] Sovich, J.L., Sartor, Z. and Misra, S., 2015, Developments in screening tests and strategies for colorectal cancer, Biomed. Res. Int. Article ID 326728, 11 p.
[15] Lieberman, D.A., 2009, Clinical practice: Screening for colorectal cancer, N. Engl. J. Med. 361: 1179-1187.
[16] Pullens, H.J. and Siersema, P.D., 2014, Quality indicators for colonoscopy: Current insights and caveats, World. J. Gastrointest Endosc. 6: 571-583.
[17] Droste, J.S.T., Oort F.A., Hulst, R.W.M.V.D., et al., 2011, Higher fecal immunochemical test cut off levels: Lower positivity rates but still acceptable detection rates for early-stage colorectal cancers, Cancer Epidemiol. Biomarkers Prev. 20: 272-280.
[18] Hajian-Tilaki, K., 2014, Sample size estimation in diagnostic test studies of biomedical informatics, J. Biomed. Inform. 48: 193-204.
[19] Yamane, T., 1973, Statistics: An Introductory Analysis, John Weather Hill, Inc., London.
[20] National Committee for Clinical Laboratory Standards, Method comparison and bias estimation using patient samples, 1995, Approved guideline, NCCLS document EP9-A, Villanova, PA, NCCLS. 15: 1-36.
[21] Instruction for use: Fecal occult blood Rapydtest® products: APA131-V3, 2014, Berkshire, UK.
[22] Instruction for use: Immunoassay latex agglutination for fecal occult blood product: 380094-B, 2011, Eiken Chemical Co., Ltd., Japan.
[23] ชยันตร์ธร ปทุมานนท์, 2556, สถิติศาสตร์คลินิก, หน่วยระบาดวิทยาคลินิก ศูนย์วิจัยคลินิก คณะแพทยศาสตร์ มหาวิทยาลัยธรรมศาสตร์, ปทุมธานี, 272 น.
[24] Allison, J.E., Sakoda ,L.C., Levin, T.R., et al., 2007, Screening for colorectal neoplasms with new fecal occult blood tests: Update on performance characteristics, J. Natl. Cancer Inst. 99: 1462-1470.
[25] Sobhani, I., Alzahouri, K. and Ghout, I., 2011, Cost-effectiveness of mass screening for colorectal cancer: Choice of fecal occult blood test and screening strategy, Dis. Colon Rectum. 54: 876-886.
[26] U.S. Preventive Services Task Force, 2008, Screening for colorectal cancer: U.S. pre-ventive services task force recommenda-tion statement, Ann. Int. Med. 149: 627-637.
[27] Ahlquist, D.A., Skoletsky, J.E. and Boynton, K.A., 2000, Colorectal cancer screening by detection of altered human DNA in stool: Feasibility of a multi target assay panel, Gastroenterology 119: 1219-1227.
[28] Elsafi, S.H., Alqahtani, N.I., Zakary, N.Y. and Al Zahrani, E.M., 2015, The sensitivity, specificity, predictive values, and likelihood ratios of fecal occult blood test for the detection of colorectal cancer in hospital settings, Clin. Exp. Gastroenterol. 8: 279-284.
[29] Faivre, J., Dancourt, V. and Lejeune, C., 2012, Screening for colorectal cancer with immunochemical faecal occult blood tests, Dig. Liver Dis. 44: 967- 973.
[30] Vilkin, A., Rozen, P. and Levi, Z., 2005, Performance characteristics and evalua-tion of an automated developed and quantitative, immunochemical, fecal occult blood screening test, Am. J. Gastroenterol. 100: 2519-2525.
[31] Rozen, P., Comaneshter, D. and Levi, Z., 2010, Cumulative evaluation of a quanti-tative immunochemical fecal occult blood test to determine its optimal clinical use, Cancer 116: 2115-2125.
[32] Young, G.P., Symonds, E.L., Allison, J.E., Cole, S.R., Fraser, C.G. and Halloran, S.P., 2015, Advances in fecal occult blood tests: The FIT revolution, Dig. Dis. Sci. 60: 609-622.
[33] McDonald, P.J., Strachan, J.A, Digby, J., Steele, R.J. and Fraser, C.G., 2011, Faecal haemoglobin concentrations by gender and age: Implications for population-based screening for colorectal cancer, Clin. Chem. Lab. Med. 50: 935-940.
[34] Turenhout, S.T., Oort, F.A., Hulst, R.W.M., Visscher, A.P., Droste, J.S.T. and Scholten, P., 2014, Prospective cross-sectional study on faecal immunochemical tests: Sex specific cut-off values to obtain equal sensitivity for colorectal cancer?, BMC. Gastroenterol. 14: 1-10.
[35] Stegeman, I., de Wijkerslooth, T.R. and Stoop, E.M., 2014, Combining risk factors with faecal immunochemical test outcome for selecting CRC screenees for colonoscopy, Gut 63: 466-471.
[36] Guittet, L., Guillaume, E., Levillain, R., et al., 2011, Analytical comparison of three quantitative immunochemical fecal occult blood tests for colorectal cancer screening, Cancer Epidemiol. Biomarkers Prev. 20: 1492-1501.
[37] van Rossum, L.G., van Rijn, A.F., van Oijen, M.G., et al., 2009, False negative fecal occult blood tests due to delayed sample return in colorectal cancer screening, Int. J. Cancer 125: 746-750.
[38] van Roon, A.H., Hol, L. and van Vuuren, A.J. and van Leerdam, M., 2012, Are fecal immunochemical test characteristics influ-enced by sample return time? A population-based colorectal cancer screening trial, Am. J. Gastroenterol. 107: 99-107.