Comparison of conventional guaiac to four immunochemical methods for fecal occult blood testing: Implications for clinical practice in hospital and outpatient settings

Tannous, Bakhos A.; Lee-Lewandrowski, Elizabeth; Sharples, Cyrrene; Brugge, William R.; Bigatello, Luca M.; Thompson, Taylor V.; Benzer, Theodore I.; Lewandrowski, Kent

doi:10.1016/j.cca.2008.10.023

Cited by 17 publications

(13 citation statements)

References 9 publications

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“…Our finding of frequent occurrence of borderline test results and major discrepancies between different immunochromatographical FOBTs in a large sample of screening participants is in line with and extends recent observations in a much smaller sample of patients ( n = 71) recruited in hospital and outpatient settings 10. For tests taken from the same stool bowel movement, between‐test variation may reflect either within‐sample heterogeneity of hemoglobin concentration or differences in the performance of tests.…”

Section: Discussionsupporting

confidence: 90%

“…A major advantage of immunochromatographical tests is their easy on‐site implementation without the need of specific laboratory equipment. However, recent studies have disclosed major differences in the analytical performance of various tests 7, 10. In particular, we have shown in a study among 1,319 participants of screening colonoscopy that positivity rates, sensitivity and specificity of 6 qualitative immunochromatographical FOBTs, taken on stool samples from a single bowel movement, were varying widely across tests 7.…”

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confidence: 87%

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Inter‐test agreement and quantitative cross‐validation of immunochromatographical fecal occult blood tests

Brenner

Haug

Hundt

2010

Intl Journal of Cancer

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Immunochromatographical fecal occult blood tests were shown to have higher sensitivity for detecting colorectal neoplasms than the commonly used guaiac-based test. However, positivity rates, sensitivity and specificity vary widely. We aimed to assess the reasons for this heterogeneity. Six dichotomous (qualitative) immunochromatographical tests were used in the same stool samples, taken before cathartic bowel preparation, from 1,330 participants of the German colonoscopy screening program. Positivity rates were determined, and inter-test agreement beyond chance was quantified by kappa coefficients (j). In addition, kappa coefficients were expressed in relation to their maximum possible values given differences in test positivity rates (j/j max ). Furthermore, the distribution of fecal hemoglobin concentration was assessed by an additional quantitative test in participants classified as clearly positive, borderline positive or clearly negative according to the qualitative tests. Positivity rates strongly varied from 6.4 to 46.8%. As a result, overall agreement between tests was only poor to moderate, with j ranging from 0.14 to 0.61. However, apart from the different positivity rates, agreement was mostly very high, with j/j max ranging from 0.53 to 1.00, and exceeding 0.70 in 12 of 15 cases. Distribution of fecal hemoglobin concentrations in the various categories strongly varied across tests. The observed patterns suggest that the strongly different positivity rates essentially reflect different cutoff levels of tests with otherwise very high inter-test agreement. Definition of cutoffs is a critical issue in the application of immunochromatographical tests and should be redefined for several of these tests.Fecal occult blood tests (FOBTs) are widely recommended and used for early detection of colorectal cancer (CRC) and its precursors.1 In particular, the guaiac-based FOBT, whose application has been shown to reduce incidence and mortality of CRC under trial conditions, 2 has been used for decades. In recent years, there has been increasing interest in immunochemical FOBTs, which overcome several analytical problems and might show better diagnostic performance compared with the guaiac-based FOBT.3-9 Both quantitative and qualitative (dichotomous) tests have been developed and are propagated for population-based screening. The latter are chromatographical tests requiring a visual interpretation of test results as positive or negative. A major advantage of immunochromatographical tests is their easy on-site implementation without the need of specific laboratory equipment. However, recent studies have disclosed major differences in the analytical performance of various tests. 7,10 In particular,we have shown in a study among 1,319 participants of screening colonoscopy that positivity rates, sensitivity and specificity of 6 qualitative immunochromatographical FOBTs, taken on stool samples from a single bowel movement, were varying widely across tests. 7 We aimed to explore the reasons for this heterogeneity by (i) ...

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Section: Discussionsupporting

confidence: 90%

mentioning

confidence: 87%

Inter‐test agreement and quantitative cross‐validation of immunochromatographical fecal occult blood tests

Brenner

Haug

Hundt

2010

Intl Journal of Cancer

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“…A qualitative FIT, which most often makes use of immunochromatographic technology, facilitates simple, office-based analysis. Large differences, however, exist in the diagnostic performance of qualitative FIT variants [5,10,19]. A study assessing the cause of these differences found that fecal hemoglobin concentration varied widely between tests [10,20].…”

Section: Discussionmentioning

confidence: 94%

A comparison of qualitative and quantitative fecal immunochemical tests in the Korean national colorectal cancer screening program

Park

Choi

Lee

et al. 2012

Scandinavian Journal of Gastroenterology

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“…Recently it has been demonstrated that there are large differences in diagnostic performance between different test variants of the qualitative FIT, as is also the case for gFOBT [8,49]. A study assessing the cause of these differences found that the distribution of faecal haemoglobin concentrations strongly varies across tests [48].…”

Section: Qualitative Fitmentioning

confidence: 98%

Performance improvements of stool-based screening tests

Dam

Kuipers

Leerdam

2010

Best Practice & Research Clinical Gastroenterology

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Comparison of conventional guaiac to four immunochemical methods for fecal occult blood testing: Implications for clinical practice in hospital and outpatient settings

Cited by 17 publications

References 9 publications

Inter‐test agreement and quantitative cross‐validation of immunochromatographical fecal occult blood tests

Inter‐test agreement and quantitative cross‐validation of immunochromatographical fecal occult blood tests

A comparison of qualitative and quantitative fecal immunochemical tests in the Korean national colorectal cancer screening program

Performance improvements of stool-based screening tests

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