Affiliation:
1. NHS Bowel Cancer Screening Programme Southern Hub , Royal Surrey County Hospital , Guildford , England , UK
2. Berkshire and Surrey Pathology Services, Royal Surrey County Hospital , Guildford , England , UK
Abstract
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.
Subject
Biochemistry, medical,Clinical Biochemistry,General Medicine
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