Performance Evaluation of the HM-JACKarc Analyser for Fecal Occult Blood Test.
10.15263/jlmqa.2016.38.3.137
- Author:
Yumi PARK
1
;
Qute CHOI
;
Gye Cheol KWON
;
Sun Hoe KOO
Author Information
1. Department of Laboratory Medicine, Chungnam National University College of Medicine, Daejeon, Korea. shkoo@cnu.ac.kr
- Publication Type:Original Article
- Keywords:
Fecal occult blood test;
Colorectal neoplasms;
HM-JACKarc
- MeSH:
Agglutination;
Colorectal Neoplasms;
Hemorrhage;
Latex;
Mass Screening;
Methods;
Occult Blood*
- From:Journal of Laboratory Medicine and Quality Assurance
2016;38(3):137-142
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
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 OCSENSOR 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.
