[Evaluation of the OC-SENSOR neo system for testing fecal occult blood].
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 R2=0.954 (P<0.001) for 60 OC I-positive specimens. The positive and negative interpretations of 300 consecutive specimens by OC neo were completely consistent with those of OC I.


CONCLUSIONS
Because OC neo showed an excellent performance and a good correlation with OC I, OC neo warrants to be a reliable quantitative FOBT system for high volume laboratories.
Kim
Ji Hyun
JH
Department of Laboratory Medicine, University of Ulsan College of Medicine and Asan Medical Center, Seoul, Korea.
Chung
Hee-Jung
HJ
Yoon
Nam Surp
NS
Pyo
Yeon Jeong
YJ
Bae
Hye Gyung
HG
Kim
Mi-Na
MN
D015179:Colorectal Neoplasms / Q000175:diagnosis*; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D008403:Mass Screening / Q000295:instrumentation* / Q000379:methods; D009780:Occult Blood; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D006454:Hemoglobins