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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
Published/Copyright: November 18, 2017
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 56 Issue 4

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.

Keywords: adenoma; analyser evaluation; colorectal cancer; faecal haemoglobin; faecal immunochemical test

  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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https://doi.org/10.1515/cclm-2017-0605
Keywords for this article
adenoma; analyser evaluation; colorectal cancer; faecal haemoglobin; faecal immunochemical test

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Visual assessment of sample quality: quo usque tandem?
  4. Reviews
  5. Machine learning in laboratory medicine: waiting for the flood?
  6. Is irisin the new player in exercise-induced adaptations or not? A 2017 update
  7. Opinion Paper
  8. Can a combination of average of normals and “real time” External Quality Assurance replace Internal Quality Control?
  9. Genetics and Molecular Diagnostics
  10. The UGT1A1*28 gene variant predicts long-term mortality in patients undergoing coronary angiography
  11. General Clinical Chemistry and Laboratory Medicine
  12. Laboratory performance of sweat conductivity for the screening of cystic fibrosis
  13. Making sense of a haemolysis monitoring and reporting system: a nationwide longitudinal multimethod study of 68 Australian laboratory participant organisations
  14. Visual assessment of hemolysis affects patient safety
  15. Strong impact on plasma protein profiles by precentrifugation delay but not by repeated freeze-thaw cycles, as analyzed using multiplex proximity extension assays
  16. Validation of the Six Sigma Z-score for the quality assessment of clinical laboratory timeliness
  17. Proficiency testing program for hemoglobin E, A2 and F analysis in Thailand using lyophilized hemoglobin control materials
  18. Application of κ free light chains in cerebrospinal fluid as a biomarker in multiple sclerosis diagnosis: development of a diagnosis algorithm
  19. Antiphosphatidylserine/prothrombin antibodies (aPS/PT) as potential diagnostic markers and risk predictors of venous thrombosis and obstetric complications in antiphospholipid syndrome
  20. An evaluation of the SENTiFIT 270 analyser for quantitation of faecal haemoglobin in the investigation of patients with suspected colorectal cancer
  21. Evaluation of the Aptima HBV Quant assay vs. the COBAS TaqMan HBV test using the high pure system for the quantitation of HBV DNA in plasma and serum samples
  22. Reference Values and Biological Variations
  23. Reference intervals for stone risk factors in 24-h urine among healthy adults of the Han population in China
  24. Cardiovascular Diseases
  25. Rule-out of non-ST elevation myocardial infarction by five point of care cardiac troponin assays according to the 0 h/3 h algorithm of the European Society of Cardiology
  26. Infectious Diseases
  27. Diagnostic and prognostic value of presepsin vs. established biomarkers in critically ill patients with sepsis or systemic inflammatory response syndrome
  28. Association of adrenal hormone metabolites and mortality over a 6-year follow-up in COPD patients with acute exacerbation
  29. Corrigendum
  30. Corrigendum to: Validation of a pneumatic tube system to transport surgical pathology biopsy samples
  31. Letters to the Editor
  32. A transnational collaborative network dedicated to the study and applications of the vascular endothelial growth factor-A in medical practice: the VEGF Consortium
  33. Detection and a functional characterization of the novel FBN1 intronic mutation underlying Marfan syndrome: case presentation
  34. Effect of haemolysis on the determination of CCL17/thymus and activation-regulated chemokine (TARC) and CCL22/macrophage-derived chemokine (MDC)
  35. Evaluation of long-term stability of cannabinoids in standardized preparations of cannabis flowering tops and cannabis oil by ultra-high-performance liquid chromatography tandem mass spectrometry
  36. Impact of citrated blood collection tubes on red cell morphology: implications for the measurement of plasma glucose
  37. Validation of a pneumatic tube system to transport surgical pathology biopsy samples
  38. Antioxidant capacity in patients with type 2 diabetes: a preliminary investigation on gender-specific differences in an Italian population
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