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

다영 강¹² 도균 김^*1 건한 김¹ 인호 장² 석훈 정¹

¹ Department of Laboratory Medicine and Research Institute of Bacterial Resistance,Yonsei University College of Medicine, Seoul,
² Department of Clinical Pathology, Sangji University College of Health Science, Wonju

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. (Ann Clin Microbiol 2019;22:29-34)

Keywords

Colon cancer Linearity Occult blood Precision SENTiFIT 270-FOB Gold

Acknowledgements

This work was supported by the annual clinical research grant from Pusan National University Yangsan Hospital.

Figures & Tables

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

Figures & Tables

Table 1. Precision for FOB Gold with SENTiFIT 270 and HITACHI 7180

Parameters	SENTiFIT 270	HITACHI 7180
Low level	High level	Low level	High level
Mean	83.15	298.10	85.64	312
Within run
SD	3.26	5.60	3.22	4.79
CV (%)	3.92	1.88	3.75	1.54
Between run
SD	1.08	2.40	2.14	3.52
CV (%)	1.30	0.81	2.50	1.13
Between day
SD	2.92	4.51	1.59	2.71
CV (%)	3.51	1.51	1.85	0.87
Total
SD	4.11	7.58	3.94	6.53
CV (%)	4.94	2.54	4.60	2.09