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

Annals of Clinical Microbiology Pub Date : 2019-06-01 DOI:10.5145/acm.2019.22.2.29

Dayoung Kang, Dokyun Kim, Keonhan Kim, I. Jang, S. Jeong

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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 com-parative inspection ability. (Ann Clin Microbiol 2019; 22:29-34)

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SENTiFIT 270与FOB金试剂检测粪便潜血的性能评价

背景：粪便潜血试验已广泛应用于大肠癌的筛查。SENTiFIT 270（意大利Sentinel诊断公司）是一种利用FOB Gold试剂的免疫化学方法进行的粪便潜血测试。我们使用FOB Gold试剂评估了SENTiFIT 270的性能。此外，通过日立7180（日本有限公司）对FOB黄金进行了评估。方法：根据适用的临床和实验室标准研究所指南评估SENTiFIT 270的精密度和线性。使用粪便样本对SENTiFIT 270-FOB Gold和OC传感器（Eiken chemical Co.，Japan）进行比较研究。结果：在精密度评价中，SENTiFIT 270-FOB金在高浓度和低浓度下的总精密度分别为4.94%和2.54%。日立7180-FOB黄金在高浓度和低浓度下的精密度分别为4.60%和2.09%。SENTiFIT 270-FOB Gold和日立7180-FOB Gold的线性度也很好，分别为0.9987和0.9986。SENTITIF 270-FOB Gold显示出良好的一致性，kappa值为0.830，一致率为93.6%。HITACHI 7180-FOB Gold显示出高度一致性，kappa值为0.832，一致性为93.9%。（Ann Clin Microbiol 2019；22:29-34）

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Annals of Clinical Microbiology

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8 weeks