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

被引：2

作者：

James, T. ^{[1
]}

Nicholson, B. D. ^{[2
]}

Marr, R. ^{[1
]}

Paddon, M. ^{[1
]}

East, J. E. ^{[3
,4
]}

Justice, S. ^{[1
]}

Oke, J. L. ^{[2
]}

Shine, B. ^{[1
]}

机构：

[1] Oxford Univ Hosp Trust, John Radcliffe Hosp, Dept Clin Biochem, Oxford OX3 9DU, England

[2] Univ Oxford, Nuffield Dept Primary Care Hlth Sci, Oxford, England

[3] Univ Oxford, John Radcliffe Hosp, Translat Gastroenterol Unit, Oxford, England

[4] Univ Oxford, John Radcliffe Hosp, Oxford NIHR Biomed Res Ctr, Oxford, England

来源：

BRITISH JOURNAL OF BIOMEDICAL SCIENCE | 2021年 / 78卷 / 04期

关键词：

Faecal immunochemical test; analytical variation; preanalytical variation; method performance;

D O I：

10.1080/09674845.2021.1896204

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

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 mu g/g (limit of blank), 1.3 mu g/g (limit of detection) and 3.0 mu g/g (limit of quantitation). Of 33 non-homogenized specimens, 31 (93.9%) analysed in triplicate were consistently categorized relative to 10 mu g/g, compared to all 33 (100%) homogenized specimens. Imprecision was higher (median 27.8%, (range 20.5% to 48.6%)) in non-homogenized specimens than in homogenized 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 mu g/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 utilization.

引用

页码：211 / 217

页数：7