Evaluation of the OC-SENSOR neo System for Testing Fecal Occult Blood

Abstract

Background : Fecal occult blood tests (FOBTs) have been widely used as a means of colorectal cancer screening. Automated FOBTs using immunologic principles have the advantages such as quantitation, high specificity, and high throughput. We evaluated a newly-introduced automated FOBT analyzer, OC-SENSOR neo (OC neo) (Eiken Chemical Co., Japan).Methods : The precision, linearity, and carry-over rate of OC neo were assessed with specimens prepared in accordance with the guidelines of CLSI. We performed a parallel test between OC neo and OC-SENSOR I (OC I) (Eiken Chemical Co.) using 300 consecutive stool specimens and 60 OC I-positive specimens. The results were analyzed with SPSS version 13.0 (SPSS Inc., USA).Results : The coefficients of variation (CV) of within-run, between-run, and between-day using OCControl L (Eiken Chemical Co.) of ca. 150 ng/mL were 3.5-7.8%, 4.5-8.8% and 4.9-5.0%, respectively. The linear regression coefficient and carry-over rate with the range of 67.8-939.4 ng/mL were 0.9998 (P<0.001), and 0.1%, respectively. Correlation coefficient between OC neo and OC I was R

Analysis of a Comparability Test between LX Detergent Cleaning Solution and OC Detergent Cleaning Solution Using OC Sensor PLEDIA

“…However, both products showed a slightly higher % difference, 3.0∼6.0% in the middle range of AMR 50 to 1000 ng/mL. These results were similar to those in previous studies in which OC sensor series were evaluated, and it was thought that there was no significant difference in linearity between LX-CS and OC-CS [22].…”

“…In a previous study that evaluated OC NEO and OC DIANA among the OC sensor series, it can be seen that the precision was higher than that measured at 7.8% and 3.1% for low-concentration materials, and 3.5% and 2.0% for high-concentration materials, respectively [19]. Besides, in a previous study evaluating HM-JACK (Kyowa Medex, Japan) and OC IO (Eiken Chemical, Japan) at various concentrations, repeatability of positive specimens using HM JACK is 3.5% in high concentration materials and 4.8% in low concentration specimens [20].…”

Screening for colorectal cancer using a quantitative immunochemical faecal occult blood test: a feasibility study in an Asian population

“…2), in the Department of Colorectal Surgery, Singapore General Hospital. This machine, which employs the same technology as the OC-SENSOR MICRO used in several other studies [10,13,16], has been validated in a Korean study [14] and has been registered for use internationally since April 2008. Based on the manufacturer's recommendations, a faecal occult blood level of C100 ng Hb/ml was taken as a positive result.…”

“…The iFOBT has been evaluated in Japan and elsewhere [12][13][14][15] and has replaced the guaic-based FOBT in several screening programmes worldwide [12][13][14][15][16]. Furthermore, automated quantitative immunochemical FOBT (qFOBT) allows for the selection of a threshold for colonoscopy, making it an excellent screening tool.…”

Performance Evaluation of Two Automated Quantitative Fecal Occult Blood Tests

“…또한 guaiac법에 비해서 높은 민감도와 특이도를 보이며 [8], 정량이 가능해서 임계치를 설 정하여 양성 판정을 객관적으로 할 수 있다. 국내에서는 최근 임상 검사에서 10여 종의 자동화된 정량 분변잠혈검사가 도입되어 사용 중이나 [6], 성능평가는 부족하며 OC-Sensor 시리즈(Eiken Chemical, Tokyo, Japan) 중 NEO (Eiken Chemical)에 대한 성능평가 논 문만 있다 [9].…”