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

Da Young Kang; Dokyun Kim; Keonhan Kim; In-Ho Jang; Seok Hoon Jeong

doi:10.5145/ACM.2019.22.2.29

Journal List > Ann Clin Microbiol > v.22(2) > 1127920

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Kang, Kim, Kim, Jang, and Jeong: Performance Evaluation of SENTiFIT 270 and FOB Gold Reagent for Detecting Fecal Occult Blood

Original Article

Annals of Clinical Microbiology 2019; 22(2): 29-34.

Published online: 20 June 2019

DOI: https://doi.org/10.5145/ACM.2019.22.2.29

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

Da Young Kang^1,², Dokyun Kim¹, Keonhan Kim¹, In-Ho Jang², Seok Hoon Jeong¹

¹Department of Laboratory Medicine and Research Institute of Bacterial Resistance, Yonsei University College of Medicine, Seoul, Korea.

²Department of Clinical Pathology, Sangji University College of Health Science, Wonju, Korea.

Correspondence: Dokyun Kim, Department of Laboratory Medicine and Research Institute of Bacterial Resistance, Gangnam Severance Hospital, Yonsei University College of Medicine, 211 Eonju-ro, Gangnam-gu, Seoul 06273, Korea. (Tel) 82-2-2019-2776, (Fax) 82-2-2057-8926, kyunsky@yuhs.ac

Received 14 September 2018 Revised 25 November 2018 Accepted 26 November 2018

The Korean Society of Clinical Microbiology

(open-access):

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

Keywords: Colon cancer, Linearity, Occult blood, Precision, SENTiFIT 270-FOB Gold

Figures and Tables

Fig. 1

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

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.

Table 1

Precision for FOB Gold with SENTiFIT 270 and HITACHI 7180

Abbreviations: SD, standard deviation; CV, coefficient of variation.

Table 2

Comparison of the results between FOB Gold with SENTiFIT 270 and HITACHI 7180, and OC-Sensor

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