TY - JOUR
T1 - A comparison of the faecal haemoglobin concentrations and diagnostic accuracy in patients suspected with colorectal cancer and serious bowel disease as reported on four different faecal immunochemical test systems
AU - Benton, Sally C.
AU - Piggott, Carolyn
AU - Zahoor, Zahida
AU - O'Driscoll, Shane
AU - Fraser, Callum
AU - D'Souza, Nigel
AU - Chen, Michelle
AU - Delisle, Theo Georgiou
AU - Abulafi, Muti
N1 - Funding Information:
This study is a sub-study of the NICE FIT study which was funded by an NHS England award to RM Partners, the West London Cancer Alliance hosted by The Royal Marsden NHS Foundation Trust. The study was supported by the National Institute for Health Research Clinical Research Network Portfolio. Alpha Labs Ltd, MAST Diagnostics, Sysmex and Abbott/ Alfresa supported the study by providing FIT kits and reagents without charge. The study funders had no role in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.
© 2022 Walter de Gruyter GmbH, Berlin/Boston
PY - 2022
Y1 - 2022
N2 - Objectives: Faecal immunochemical tests for haemoglobin (FIT) are used in colorectal cancer (CRC) screening programmes and to triage patients presenting with symptoms suggestive of CRC for further bowel investigations. There are a number of quantitative FIT analytical systems available. Currently, there is no harmonisation or standardisation of FIT methods. The aim of the study was to assess the comparability of numerical faecal haemoglobin concentrations (f-Hb) obtained with four quantitative FIT systems and the diagnostic accuracy at different f-Hb thresholds. Methods: A subgroup of the National Institute for Health and Care Excellence (NICE) FIT study, a multicentre, prospective diagnostic accuracy study were sent four FIT specimen collection devices from four different FIT systems or two FIT devices for one FIT system. Faecal samples were examined and analysis of results carried out to assess difference between methods at thresholds of limit of detection (LoD), 10 μg haemoglobin/g faeces (μg/g) and 100 μg/g. Results: 233 patients returned specimen collection devices for examination on four different systems; 189 patients returned two FIT kits for one system. At a threshold of 100 μg/g the sensitivity is the same for all methods. At lower thresholds of LoD and 10 μg/g differences were observed between systems in terms of patients who would be referred and diagnostic accuracies. Conclusions: The lack of standardisation or harmonisation of FIT means that differences are observed in f-Hb generated on different systems. Further work is required to understand the clinical impact of these differences and to minimise them.
AB - Objectives: Faecal immunochemical tests for haemoglobin (FIT) are used in colorectal cancer (CRC) screening programmes and to triage patients presenting with symptoms suggestive of CRC for further bowel investigations. There are a number of quantitative FIT analytical systems available. Currently, there is no harmonisation or standardisation of FIT methods. The aim of the study was to assess the comparability of numerical faecal haemoglobin concentrations (f-Hb) obtained with four quantitative FIT systems and the diagnostic accuracy at different f-Hb thresholds. Methods: A subgroup of the National Institute for Health and Care Excellence (NICE) FIT study, a multicentre, prospective diagnostic accuracy study were sent four FIT specimen collection devices from four different FIT systems or two FIT devices for one FIT system. Faecal samples were examined and analysis of results carried out to assess difference between methods at thresholds of limit of detection (LoD), 10 μg haemoglobin/g faeces (μg/g) and 100 μg/g. Results: 233 patients returned specimen collection devices for examination on four different systems; 189 patients returned two FIT kits for one system. At a threshold of 100 μg/g the sensitivity is the same for all methods. At lower thresholds of LoD and 10 μg/g differences were observed between systems in terms of patients who would be referred and diagnostic accuracies. Conclusions: The lack of standardisation or harmonisation of FIT means that differences are observed in f-Hb generated on different systems. Further work is required to understand the clinical impact of these differences and to minimise them.
KW - colorectal cancer
KW - faecal haemoglobin
KW - faecal immunochemical test
KW - significant bowel disease
KW - symptomatic patients
KW - Symptomatic patients
KW - Colorectal cancer
KW - Faecal immunochemical test
KW - Significant bowel disease
KW - Faecal haemoglobin
UR - http://www.scopus.com/inward/record.url?scp=85131686673&partnerID=8YFLogxK
U2 - 10.1515/cclm-2021-1248
DO - 10.1515/cclm-2021-1248
M3 - Article
C2 - 35637625
SN - 1434-6621
VL - 60
SP - 1278
EP - 1286
JO - Clinical Chemistry and Laboratory Medicine (CCLM)
JF - Clinical Chemistry and Laboratory Medicine (CCLM)
IS - 8
ER -