Journal
CLINICAL CHEMISTRY AND LABORATORY MEDICINE
Volume 59, Issue 1, Pages 173-178Publisher
WALTER DE GRUYTER GMBH
DOI: 10.1515/cclm-2020-0251
Keywords
analytical evaluation; colorectal cancer; faecal immunochemical test; FIT
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The study evaluated four automated quantitative FIT systems and found that they all demonstrated good analytical performance and linearity. Variations in EQA sample results were observed due to the lack of standardization across different methods.
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.
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