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KMID : 1142220180130010061
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Regulatory Research on Food, Drug & Cosmetic
2018 Volume.13 No. 1 p.61 ~ p.67
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A Study on Development of Guideline to Establish Performance Evaluation for Fecal Occult Blood Test
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Lee Seung-Ro
Kim Bo-Ra
Kim Ji-Eun
Lim Chun-Il
Kim Mi-Jeong
Seo Kyung-Won
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Abstract
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Colorectal cancer is increasing in Korea due to westernization of dietary culture. In 2015, colorectal cancer was the second most common cancer. Since 2004, Korea has been conducting fecal occult blood tests for males and females over 50 years old every year through national cancer screening project, and it is contributing to increase the survival rate of patients through early treatment and rapid treatment. IVD reagents for fecal occult blood are widely used as a primary test for colorectal cancer screening, which is an in vitro diagnostic medical device that detects a small amount of blood which is not visually recognized in the human feces and confirms bleeding in digestive organs. In recent years, the FDA and the European Medicines Agency (EMA) have developed a strict protocol to strengthen the regulations. However, since the related standards and guidance have not been established, the evaluation is performed by different standards and methods. In this study, we developed test methods for the evaluation of IVD reagents for fecal occult blood using immunochromatography, which is widely used as a self-diagnostic kit for colorectal cancer. First of all, we investigated the current domestic and international status of registration, class and authorization methods. Next, the domestic and foreign standards and guidelines related to the performance evaluation of IVD reagents for fecal occult blood were investigated and analyzed, and the performance evaluation items were selected with reference to the licenses of the licensed products. The validity of the proposed performance evaluation items and the reliability of the evaluation methods were tried to be improved through practical test evaluation and verification. We will contribute to the improvement of the reliability and international competitiveness by improving the technology and quality of in vitro diagnostic medical device industry by supporting efficient medical device approval and examination work through performance evaluation test method of IVD reagents for fecal occult blood prepared in this study.
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KEYWORD
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occult blood feces, cancer screening, colorectal cancer, early diagnosis, hemoglobin
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