An evaluation of the SENTiFIT 270 analyser for quantitation of faecal haemoglobin in the investigation of patients with suspected colorectal cancer.
Clin Chem Lab Med
; 56(4): 625-633, 2018 03 28.
Article
em En
| MEDLINE
| ID: mdl-29150989
ABSTRACT
BACKGROUND:
An evaluation of SENTiFIT® 270 (Sentinel Diagnostics, Italy; Sysmex, Spain) analyser for the quantitation of faecal haemoglobin (f-Hb) was performed.METHODS:
The analytical imprecision, linearity, carry over and f-Hb stability were determined. Evaluation of the diagnostic accuracy was performed on 487 patients.RESULTS:
Within-run and between-run imprecision ranged 1.7%-5.1% and 3.8%-6.2%, respectively. Linearity studies revealed a mean recovery of 101.1% (standard deviation, 6.7%) for all dilutions. No carry over was detected below 7650 µg Hb/g faeces. Decay of f-Hb in refrigerated samples ranged 0.2%-0.5% per day. f-Hb in patients with advanced colorectal neoplasia (ACRN) (colorectal cancer [CRC] plus advanced adenoma [AA]) were significantly higher than from those with a normal colonoscopy. Sensitivity for ACRN at f-Hb cutoffs from 10 to 60 µg Hb/g faeces ranged from 28.9% (95% confidence interval [CI], 21.7%-37.2%) to 46.5% (95% CI, 38.1%-55%), the specificity ranged from 85% (95% CI, 82.3%-87.3%) to 93.2% (95% CI, 91.2%-94.8%), positive predictive values for detecting CRC and AA ranged from 11.6% (95% CI, 7.6%-17.2%) to 20.6% (95% CI, 13.3%-30.3%) and from 34.7% (95% CI, 28.1%-42%) to 42.3% (95% CI, 32.4%-52.7%), respectively, and the negative predictive value for ACRN ranged from 90.2% (95% CI, 87.9%-92.2%) to 88.4% (95% CI, 86%-90.4%). Using two samples per patient sensitivity increased with a slight decrease in specificity.CONCLUSIONS:
The analytical and clinical performances of SENTiFIT assay demonstrate a specific and accurate test for detecting ACRN in symptomatic patients and those undergoing surveillance.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Hemoglobinas
/
Imunoquímica
/
Neoplasias Colorretais
/
Fezes
Idioma:
En
Ano de publicação:
2018
Tipo de documento:
Article