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Licensed Unlicensed Requires Authentication Published by De Gruyter November 18, 2017

An evaluation of the SENTiFIT 270 analyser for quantitation of faecal haemoglobin in the investigation of patients with suspected colorectal cancer

  • Josep M. Auge EMAIL logo , Cristina Rodriguez , Oihana Espanyol , Liseth Rivero , Silvia Sandalinas , Jaume Grau , Wladimiro Jimenez and Antoni Castells

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.

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2017-7-11
Accepted: 2017-10-9
Published Online: 2017-11-18
Published in Print: 2018-3-28

©2018 Walter de Gruyter GmbH, Berlin/Boston

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