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pISSN 2950-9114 eISSN 2950-9122
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Original Article

J Lab Med Qual Assur 2016; 38(3): 137-142

Published online September 30, 2016

https://doi.org/10.15263/jlmqa.2016.38.3.137

Copyright © Korean Association of External Quality Assessment Service.

Performance Evaluation of the HM-JACKarc Analyser for Fecal Occult Blood Test

Yumi Park, Qute Choi, Gye Cheol Kwon, and Sun Hoe Koo

Department of Laboratory Medicine, Chungnam National University College of Medicine, Daejeon, Korea

Correspondence to:Sun Hoe Koo
Department of Laboratory Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, 282 Munhwa-ro, Junggu, Daejeon 35015, Korea
Tel: +82-42-280-7798 Fax: +82-42-280-5365 E-mail: shkoo@cnu.ac.kr

Received: April 6, 2016; Revised: May 31, 2016; Accepted: June 7, 2016

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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 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.

Keywords: Fecal occult blood test, Colorectal neoplasms, HM-JACKarc

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