Korean J Lab Med.  2007 Jun;27(3):210-215. 10.3343/kjlm.2007.27.3.210.

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

• Kim JH
• Chung HJ
• Yoon NS
• Pyo YJ
• Bae HG
• Kim MN

• KMID: 1781486
• DOI: http://doi.org/10.3343/kjlm.2007.27.3.210

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(2)=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.

Keyword

Fecal occult blood test; Colorectal cancer; OC-SENSOR neo; Automation

MeSH Terms

Colorectal Neoplasms/*diagnosis
Hemoglobins/*analysis
Humans
Mass Screening/*instrumentation/methods
*Occult Blood
Reproducibility of Results
Sensitivity and Specificity

Figure

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  Fig. 1. Linearity range of Hb by OC-SENSOR neo. The straight line was determined by a linear regression of the measured Hb concentrations with target Hb concentrations.

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  Fig. 2. The correlation of Hb concentrations measured with OC-SENSOR neo and OC-SENSOR I.

Reference

References

1. Kim DW, Bang YJ, Heo DS, Kim NK. Colorectal cancer in Korea: characteristics and trends. Tumori. 2002; 88:262–5.

2. Helm J, Choi J, Sutphen R, Barthel JS, Albrecht TL, Chirikos TN. Current and evolving strategies for colorectal cancer screening. Cancer Control. 2003; 10:193–204.

3. Anwar R. Screening for colorectal cancer in the UK. Dig Liver Dis. 2006; 38:279–82.

4. Bromer MQ, Weinberg DS. Screening for colorectal cancer-now and the near future. Semin Oncol. 2005; 32:3–10.

5. Winawer SJ, Fletcher RH, Miller L, Godlee F, Stolar MH, Mulrow CD, et al. Colorectal cancer screening: clinical guidelines and rationale. Gastroenterology. 1997; 112:594–642.

6. Suggested technique for fecal occult blood testing and interpretation in colorectal cancer screening. American College of Physicians. Ann Intern Med. 1997; 126:808–10.

7. Mandel JS, Bond JH, Church TR, Snover DC, Bradley GM, Schuman LM, et al. Reducing mortality from colorectal cancer by screening for fecal occult blood. Minnesota Colon Cancer Control Study. N Engl J Med. 1993; 328:1365–71.

8. Hardcastle JD, Chamberlain JO, Robinson MH, Moss SM, Amar SS, Balfour TW, et al. Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet. 1996; 348:1472–7.

9. Kronborg O, Fenger C, Olsen J, Jorgensen OD, Sondergaard O. Randomised study of screening for colorectal cancer with faecal-occult-blood test. Lancet. 1996; 348:1467–71.

10. Mandel JS, Church TR, Bond JH, Ederer F, Geisser MS, Mongin SJ, et al. The effect of fecal occult-blood screening on the incidence of colorectal cancer. N Engl J Med. 2000; 343:1603–7.

11. Steinmetz J, Spyckerelle Y, Gueguen R, Dupre C. Colorectal cancer screening in Health Examination Centers. Gastroenterol Clin Biol. 2006; 30:832–7.

12. Walsh JM, Terdiman JP. Colorectal cancer screening: scientific review. JAMA. 2003; 289:1288–96.

13. Levin B. Screening for Colorectal Cancer. Cancer Control. 1996; 3:20–5.

14. Han WS, Choi YM, Lee DH. Comparison of guaiac method with latex method for the fecal occult blood test. Korean J Clin Pathol. 1996; 16:318–23.

15. Vilkin A, Rozen P, Levi Z, Waked A, Maoz E, Birkenfeld S, et al. Performance characteristics and evaluation of an automated-developed and quantitative, immunochemical, fecal occult blood screening test. Am J Gastroenterol. 2005; 100:2519–25.

16. Horiuchi Y, Masubuchi J, Oikawa S, Matsuda R, Hishinuma A, Ieiri T. Evaluation of fully automated fecal occult blood analyzer OC-SENSOR neo and OC-SENSOR II. Jap Assoc Clin Lab Auto. 2003; 28:40–6.

17. Touzuka S, Aoyama K, Kamino T. Fundamental study on fully automated fecal occult blood immunochemical analyzer, OC-SENSOR neo. Med Exam Equip-Reag. 2002; 25:121–5.

18. National Committee for Clinical Laboratory Standards. Evaluation of the linearity of quantitative measurement procedures; A statistical approach; Approved guideline. Document EP6-A. Vilanova, PA: National Commitee for Clinical Laboratory Standards;2003.

19. National Committee for Clinical Laboratory Standards. Evaluation of precision performance of quantitative measurement methods; Approved guideline-Second edition. Document EP5-A2.Vilanova, PA: National Commitee for Clinical Laboratory Standards;2004.

20. Pesce MA. Laboratory antomation. In. Kaplan LA, Pesce AJ, editors. Clinical Chemistry. 4th ed.Baltimore: Mosby;2003. :294.

21. Hong SB, Kim HS, Park HS, Lee DH. Evaluation of the HM-JACK Automatic Analyzer for Fecal Occult Blood Test. J Lab Med Qual Assur. 2002; 24:221–4.

22. Kim DC, Cho SS, Song J, Kim EC, Kim JQ. Evaluation of the OC-SENSOR for Immunological Fecal Occult Blood Test. Korean J Clin Pathol Qual Control. 1998; 20:281–8.

23. Imperiale TF. Quantitative immunochemical fecal occult blood tests: is it time to go back to the future? Ann Intern Med. 2007; 146:309–11.