Analytical evaluation of four faecal immunochemistry tests for haemoglobin
-
Carolyn Piggott
,
Magdalen R. R. Carroll
,
Cerin John
,
Shane O’Driscoll
and
Sally C. Benton
Abstract
Objectives
Faecal immunochemical tests (FIT) for haemoglobin (Hb) are being used in the investigation of colorectal cancer. These tests use antibodies raised to the globin moiety of human Hb. Here, four automated quantitative FIT systems (HM-JACKarc, NS-Prime, OC-Sensor PLEDIA and SENTiFIT 270) are evaluated analytically to confirm whether the performance of the systems meet the manufacturers’ claims.
Methods
Assessment of the analytical performance of the FIT systems was undertaken using Hb lysates, real patient samples and external quality assessment (EQA) samples. This analytical assessment focused on detection characteristics, imprecision, linearity, prozone effect, recovery and carryover.
Results
All four methods demonstrated good analytical performance, with acceptable within- and between-run imprecision, good recovery of f-Hb and limited carryover of samples. They also all show good linearity across the range of concentrations tested. The results of EQA samples showed different variations from the target values (−52 to 45%), due to the absence of standardisation across the different methods.
Conclusions
All four systems are fit for purpose and have an analytical performance as documented by their manufacturers.
Acknowledgments
We thank FIT system suppliers (HM-JACKarc: Alpha Laboratories, Eastleigh, UK; NS-Prime: originally supplied by Alere Ltd., Chester, UK, with continuing support from Abbott, Maidenhead, UK, and Alfresa Pharma, Osaka, Japan; OC-Sensor PLEDIA: Mast Diagnostics Division, Bootle, UK; SENTiFIT 270: Sysmex UK Ltd., Milton Keynes, UK) for supplying the analysers and consumables. We also thank Berkshire and Surrey Pathology Services (Royal Surrey Foundation Trust, Guildford, UK) for supplying samples used in the assessment and the United Kingdom National External Quality Assessment Services (UK NEQAS, Birmingham, UK) for the external quality assessment (EQA) samples they provided.
Research funding: None declared.
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Competing interests: None declared.
References
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© 2020 Walter de Gruyter GmbH, Berlin/Boston
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