Diagnostic accuracy of faecal biomarkers in detecting colorectal cancer and adenoma in symptomatic patients

M. M. Widlak, C. L. Thomas, M. G. Thomas, C. Tomkins, S. Smith, N. O'Connell, S. Wurie, L. Burns, C. Harmston, C. Evans, C. U. Nwokolo, B. Singh, Ramesh P. Arasaradnam

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Abstract

Background The diagnosis of colorectal cancer (CRC) can be difficult as symptoms are variable with poor specificity. Thus, there is a quest for simple, non-invasive testing that can help streamline those with significant colonic pathology.AimTo assess using faecal immunochemical test for haemoglobin (FIT) or faecal calprotectin (FCP) to detect CRC and adenoma in symptomatic patients referred from primary care.MethodsA total of 799 referred for urgent lower gastrointestinal investigations were prospectively recruited. Of these, 430 completed colonic investigations and returned stool samples, and were included in the final statistical analysis. Faecal immunochemical test for haemoglobin was performed on HM-JACKarc analyser (Kyowa Medex, Tokyo, Japan), and FCP by the EliA Calprotectin immunoassay (Thermo Fisher Scientific, Waltham, United States).ResultsThe negative predictive value (NPV) using FIT alone or both markers (FIT and FCP) in combination was similar at 99% for CRC, with a sensitivity and specificity of 84% and 93%, respectively. FIT measurements were significantly higher in left-sided colonic lesions compared with the right side; 713 vs. 94; P = 0.0203). For adenoma, the NPV using FIT alone, or both markers (FIT and FCP) in combination, was similar at 94% with a sensitivity and specificity of 69% and 56%, respectively.ConclusionsUndetectable faecal immunochemical test for haemoglobin is sufficiently sensitive to exclude colorectal cancer, with higher values in left-sided lesions. FCP in combination does not appear to provide additional diagnostic information. Further studies to determine the health economic benefits of implementing faecal immunochemical test for haemoglobin in primary care are required.
Original languageEnglish
Pages (from-to)354-363
JournalAlimentary Pharmacology and Therapeutics
Volume45
Issue number2
Early online date1 Dec 2016
DOIs
Publication statusPublished - Jan 2017

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Leukocyte L1 Antigen Complex
Adenoma
Colorectal Neoplasms
Hemoglobins
Biomarkers
Primary Health Care
Sensitivity and Specificity
Tokyo
Insurance Benefits
Immunoassay
Japan
Economics
Pathology

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Diagnostic accuracy of faecal biomarkers in detecting colorectal cancer and adenoma in symptomatic patients. / Widlak, M. M.; Thomas, C. L.; Thomas, M. G.; Tomkins, C.; Smith, S.; O'Connell, N.; Wurie, S.; Burns, L.; Harmston, C.; Evans, C.; Nwokolo, C. U.; Singh, B.; Arasaradnam, Ramesh P.

In: Alimentary Pharmacology and Therapeutics, Vol. 45, No. 2, 01.2017, p. 354-363.

Research output: Contribution to journalArticle

Widlak, MM, Thomas, CL, Thomas, MG, Tomkins, C, Smith, S, O'Connell, N, Wurie, S, Burns, L, Harmston, C, Evans, C, Nwokolo, CU, Singh, B & Arasaradnam, RP 2017, 'Diagnostic accuracy of faecal biomarkers in detecting colorectal cancer and adenoma in symptomatic patients' Alimentary Pharmacology and Therapeutics, vol. 45, no. 2, pp. 354-363. https://doi.org/10.1111/apt.13865
Widlak, M. M. ; Thomas, C. L. ; Thomas, M. G. ; Tomkins, C. ; Smith, S. ; O'Connell, N. ; Wurie, S. ; Burns, L. ; Harmston, C. ; Evans, C. ; Nwokolo, C. U. ; Singh, B. ; Arasaradnam, Ramesh P. / Diagnostic accuracy of faecal biomarkers in detecting colorectal cancer and adenoma in symptomatic patients. In: Alimentary Pharmacology and Therapeutics. 2017 ; Vol. 45, No. 2. pp. 354-363.
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abstract = "Background The diagnosis of colorectal cancer (CRC) can be difficult as symptoms are variable with poor specificity. Thus, there is a quest for simple, non-invasive testing that can help streamline those with significant colonic pathology.AimTo assess using faecal immunochemical test for haemoglobin (FIT) or faecal calprotectin (FCP) to detect CRC and adenoma in symptomatic patients referred from primary care.MethodsA total of 799 referred for urgent lower gastrointestinal investigations were prospectively recruited. Of these, 430 completed colonic investigations and returned stool samples, and were included in the final statistical analysis. Faecal immunochemical test for haemoglobin was performed on HM-JACKarc analyser (Kyowa Medex, Tokyo, Japan), and FCP by the EliA Calprotectin immunoassay (Thermo Fisher Scientific, Waltham, United States).ResultsThe negative predictive value (NPV) using FIT alone or both markers (FIT and FCP) in combination was similar at 99{\%} for CRC, with a sensitivity and specificity of 84{\%} and 93{\%}, respectively. FIT measurements were significantly higher in left-sided colonic lesions compared with the right side; 713 vs. 94; P = 0.0203). For adenoma, the NPV using FIT alone, or both markers (FIT and FCP) in combination, was similar at 94{\%} with a sensitivity and specificity of 69{\%} and 56{\%}, respectively.ConclusionsUndetectable faecal immunochemical test for haemoglobin is sufficiently sensitive to exclude colorectal cancer, with higher values in left-sided lesions. FCP in combination does not appear to provide additional diagnostic information. Further studies to determine the health economic benefits of implementing faecal immunochemical test for haemoglobin in primary care are required.",
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AU - Widlak, M. M.

AU - Thomas, C. L.

AU - Thomas, M. G.

AU - Tomkins, C.

AU - Smith, S.

AU - O'Connell, N.

AU - Wurie, S.

AU - Burns, L.

AU - Harmston, C.

AU - Evans, C.

AU - Nwokolo, C. U.

AU - Singh, B.

AU - Arasaradnam, Ramesh P.

N1 - The full text is currently unavailable on the repository.

PY - 2017/1

Y1 - 2017/1

N2 - Background The diagnosis of colorectal cancer (CRC) can be difficult as symptoms are variable with poor specificity. Thus, there is a quest for simple, non-invasive testing that can help streamline those with significant colonic pathology.AimTo assess using faecal immunochemical test for haemoglobin (FIT) or faecal calprotectin (FCP) to detect CRC and adenoma in symptomatic patients referred from primary care.MethodsA total of 799 referred for urgent lower gastrointestinal investigations were prospectively recruited. Of these, 430 completed colonic investigations and returned stool samples, and were included in the final statistical analysis. Faecal immunochemical test for haemoglobin was performed on HM-JACKarc analyser (Kyowa Medex, Tokyo, Japan), and FCP by the EliA Calprotectin immunoassay (Thermo Fisher Scientific, Waltham, United States).ResultsThe negative predictive value (NPV) using FIT alone or both markers (FIT and FCP) in combination was similar at 99% for CRC, with a sensitivity and specificity of 84% and 93%, respectively. FIT measurements were significantly higher in left-sided colonic lesions compared with the right side; 713 vs. 94; P = 0.0203). For adenoma, the NPV using FIT alone, or both markers (FIT and FCP) in combination, was similar at 94% with a sensitivity and specificity of 69% and 56%, respectively.ConclusionsUndetectable faecal immunochemical test for haemoglobin is sufficiently sensitive to exclude colorectal cancer, with higher values in left-sided lesions. FCP in combination does not appear to provide additional diagnostic information. Further studies to determine the health economic benefits of implementing faecal immunochemical test for haemoglobin in primary care are required.

AB - Background The diagnosis of colorectal cancer (CRC) can be difficult as symptoms are variable with poor specificity. Thus, there is a quest for simple, non-invasive testing that can help streamline those with significant colonic pathology.AimTo assess using faecal immunochemical test for haemoglobin (FIT) or faecal calprotectin (FCP) to detect CRC and adenoma in symptomatic patients referred from primary care.MethodsA total of 799 referred for urgent lower gastrointestinal investigations were prospectively recruited. Of these, 430 completed colonic investigations and returned stool samples, and were included in the final statistical analysis. Faecal immunochemical test for haemoglobin was performed on HM-JACKarc analyser (Kyowa Medex, Tokyo, Japan), and FCP by the EliA Calprotectin immunoassay (Thermo Fisher Scientific, Waltham, United States).ResultsThe negative predictive value (NPV) using FIT alone or both markers (FIT and FCP) in combination was similar at 99% for CRC, with a sensitivity and specificity of 84% and 93%, respectively. FIT measurements were significantly higher in left-sided colonic lesions compared with the right side; 713 vs. 94; P = 0.0203). For adenoma, the NPV using FIT alone, or both markers (FIT and FCP) in combination, was similar at 94% with a sensitivity and specificity of 69% and 56%, respectively.ConclusionsUndetectable faecal immunochemical test for haemoglobin is sufficiently sensitive to exclude colorectal cancer, with higher values in left-sided lesions. FCP in combination does not appear to provide additional diagnostic information. Further studies to determine the health economic benefits of implementing faecal immunochemical test for haemoglobin in primary care are required.

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SN - 0269-2813

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