Ann Clin Microbiol.  2019 Jun;22(2):29-34. 10.5145/ACM.2019.22.2.29.

Performance Evaluation of SENTiFIT 270 and FOB Gold Reagent for Detecting Fecal Occult Blood

• Kang DY
• Kim D
• Kim K
• Jang IH
• Jeong SH

• KMID: 2450000
• DOI: http://doi.org/10.5145/ACM.2019.22.2.29

Abstract

BACKGROUND
Fecal occult blood tests have been widely used to screen for colorectal cancer. SENTiFIT 270 (Sentinel diagnostics, Italy) is a fecal occult blood test with an immunochemical method that utilizes FOB Gold reagents. We evaluated the performance of SENTiFIT 270 using the FOB Gold reagent. In addition, FOB Gold was evaluated with the HITACHI 7180 (Hitachi Ltd., Japan).
METHODS
The precision and linearity of the SENTiFIT 270 was evaluated in accordance with applicable Clinical and Laboratory Standard Institute guidelines. The comparison study between SENTiFIT 270-FOB Gold and the OC-Sensor (Eiken chemical Co., Japan) was performed using stool specimens.
RESULTS
In the precision evaluation, the total precision of SENTiFIT 270-FOB Gold was 4.94% and 2.54% at high and low concentrations, respectively. The HITACHI 7180-FOB Gold had excellent precision of 4.60% and 2.09% at high and low concentrations, respectively. Linearity was also excellent for the SENTiFIT 270-FOB Gold and HITACHI 7180-FOB Gold at 0.9987 and 0.9986, respectively. The SENTITIF 270-FOB Gold showed excellent agreement with a kappa value of 0.830 and a concordance rate of 93.6%. The HITACHI 7180-FOB Gold showed high agreement with a kappa value of 0.832 and a concordance rate of 93.9%.
CONCLUSION
The SENTiFIT 270-FOB Gold showed excellent performance in accuracy, linearity, and comparative inspection ability.

Keyword

Colon cancer; Linearity; Occult blood; Precision; SENTiFIT 270-FOB Gold

MeSH Terms

Colonic Neoplasms
Colorectal Neoplasms
Indicators and Reagents
Methods
Occult Blood*
Indicators and Reagents

Figure

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  Fig. 1 Linearity of SENTiFIT 270-FOB Gold (A) and HITACHI 7180-FOB Gold (B).

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  Fig. 2 Quantitative results of SENTiFIT 270-FOB Gold (A) and HITACHI 7180-FOB Gold (B) comparing with those of OC-Sensor PLEDIA. Black lines indicate Passing-Bablock fit lines, and grey lines indicate the identity lines.

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