Faecal immunochemical testing (FIT): sources of result variation based on three years of routine testing of symptomatic patients in English primary care.
Br J Biomed Sci
; 78(4): 211-217, 2021 Oct.
Article
en En
| MEDLINE
| ID: mdl-33627037
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 andMethods:
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-homogenized specimens, 31 (93.9%) analysed in triplicate were consistently categorized relative to 10 µg/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 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 utilization.Palabras clave
Texto completo:
1
Colección:
01-internacional
Asunto principal:
Atención Primaria de Salud
/
Hemoglobinas
/
Inmunohistoquímica
/
Neoplasias Colorrectales
/
Detección Precoz del Cáncer
/
Heces
/
Sangre Oculta
Tipo de estudio:
Diagnostic_studies
/
Guideline
/
Prognostic_studies
/
Screening_studies
Límite:
Humans
País/Región como asunto:
Europa
Idioma:
En
Revista:
Br J Biomed Sci
Asunto de la revista:
BIOLOGIA
/
TECNICAS E PROCEDIMENTOS DE LABORATORIO
Año:
2021
Tipo del documento:
Article
País de afiliación:
Reino Unido