J Lab Med Qual Assur.  2016 Sep;38(3):137-142. 10.15263/jlmqa.2016.38.3.137.

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

• Park Y
• Choi Q
• Kwon GC
• Koo SH

• KMID: 2357083
• DOI: http://doi.org/10.15263/jlmqa.2016.38.3.137

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.

Keyword

Fecal occult blood test; Colorectal neoplasms; HM-JACKarc

MeSH Terms

Agglutination
Colorectal Neoplasms
Hemorrhage
Latex
Mass Screening
Methods
Occult Blood*
Latex