Faecal immunochemical testing (FIT): sources of result variation based on three years of routine testing of symptomatic patients in English primary care

Abstract

Introduction:We aimed to determine the analytical capabilities of a commonly used faecal immunochemical test (FIT) to detect faecal haemoglobin (Hb) in symptomatic people attending primary care in the context of the English NICE DG30 guidance.Materials and Methods: Data obtained from independent verification studies and clinical testing of the HM-JACKarc FIT method in routine primary care practice were analysed to derive performance characteristics.Results: Detection capabilities for the FIT method were 0.5 µg/g (limit of blank), 1.3 µg/g (limit of detection) and 3.0 µg/g (limit of quantitation). Of 33 non-homogenised specimens, 31 (93.9%) analysed in triplicate were consistently categorised relative to 10 µg/g, compared to all 33 (100%) homogenised specimens. Imprecision was higher (median 27.8%, (range 20.5% to 48.6%)) in non-homogenised specimens than in homogenised specimens (10.2%, (7.0 to 13.5%)). Considerable variation was observed in sequential clinical specimens from individual patients but no positive or negative trend in specimen degradation was observed over time (p=0.26). Discussion:The FIT immunoassay evaluated is capable of detecting faecal Hb at concentrations well below the DG30 threshold of 10 µg/g and is suitable for application in this context. The greatest practical challenge to FIT performance is reproducible sampling, the pre-analytical step associated with most variability. Further research should focus on reducing sampling variability, particularly as post COVID-19 guidance recommends greater FIT utilisation.

Evaluation of the Sentinel-FOB gold faecal immunochemical test for the presence of haemoglobin using the automated Roche Cobas 8000 system

“…The amount of faeces taken by the collection picker of the device can vary or samples could be homogenized insufficiently after insertion of the collection picker into the buffer. This affects the f-Hb concentration in the sample [ 20 , 21 ]. Assuming that the samples for assessing the analytical imprecision in our study each time would have been taken by using the collection picker of the device before analyzing, the calculated analytical imprecision would have been higher.…”

Combining faecal immunochemical testing with blood test results to identify patients with symptoms at risk of colorectal cancer: a consecutive cohort of 16,604 patients tested in primary care

“…Immunoassay reproducibility assessed across 12 months had a coefficient of variation (CV) of between 4.4 and 8.8%. The overall imprecision of the process including sampling variation was between 7.0 and 13.5 CV% 17 . FIT samples were assayed and recorded prior to and independent of the any subsequent pathology findings.…”