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KMID : 0985420160380030137
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Laboratory Medicine and Quality Assurance
2016 Volume.38 No. 3 p.137 ~ p.142
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Performance Evaluation of the HM-JACKarc Analyser for Fecal Occult Blood Test
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Park Yu-Mi
Choi Qu-Te
Kwon Kye-Chul
Koo Sun-Hoe
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Abstract
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Background: Fecal occult blood tests have been widely used as a means of gastrointestinal bleeding and colorectal cancer screening. HM-JACKarc (Kyowa Medex Co. Ltd, Japan) is a recently introduced automated fecal occult blood test analyser, which uses latex agglutination method. We evaluated the analytical performance of HM-JACKarc.
Methods: The linearity and precision for HM-JACKarc were evaluated according to the corresponding Clinical and Laboratory Standard Institute guidelines. The comparison study between HM-JACKarc and OC-SENSOR DIANA (Eiken Chemical Co. Ltd., Japan) was done with stool specimens.
Results: The linearity was good (R2=0.999) and the coefficients of variation of within-day precision and between-day precision were 5.2% and 4.9%, respectively, in low concentration and 2.7% each in high concentration. The concordance rate between HM-JACKarc and OC-SENSOR DIANA was 99.0% (198 out of 200).
Conclusions: HM-JACKarc showed excellent performance in linearity, precision, and comparison studies. Therefore, it appears to be a useful automated fecal occult blood test analyser.
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KEYWORD
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Fecal occult blood test, Colorectal neoplasms, HM-JACKarc
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