Evaluation of cardiac assays on a benchtop chemiluminescent enzyme immunoassay analyzer, PATHFAST

doi:10.1016/j.ab.2007.12.030

Analytical Biochemistry

Volume 375, Issue 1, 1 April 2008, Pages 144-146

https://doi.org/10.1016/j.ab.2007.12.030 Get rights and content

Abstract

Devices for cardiac immunoassay are widely available at point of care settings. The lateral flow method is the most popular solution for ease of use. But its major shortcomings, poor assay precision, and low analytical sensitivity may lead to false negative results. Therefore, confirmatory testing by a routine lab analyzer sometimes is necessary. In the current study, we evaluated the cardiac assays troponin I, MB isoenzyme of creatine kinase, myoglobin, and N-terminal pro brain natriuretic peptide on a chemiluminescent enzyme immunoassay analyzer, PATHFAST. All of the assays demonstrated correlation coefficients higher than 0.97 against the predicate devices along with good total precision (coefficients of variation <10%), and the troponin I assay showed analytical sensitivity in conformance with the guidelines of European Society of Cardiology/American College of Cardiology and National Academy of Clinical Biochemistry. We concluded that the system was rapid and easy to use without compromising analytical performance.

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Acknowledgment

We thank Professor Masafumi Yohda (Tokyo University of Agriculture and Technology) for extensive review of the manuscript.

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¹: Current address: PATHFAST Group, POCT Business Department, Mitsubishi Chemical Medience Corporation, 2-8 Shibaura, 4 Minato, Tokyo 108-8559, Japan.

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Notes & TipsEvaluation of cardiac assays on a benchtop chemiluminescent enzyme immunoassay analyzer, PATHFAST

Abstract

Section snippets

Acknowledgment

Cardiology

J. Biosci. Bioeng.

Cardiac markers: Centralized or decentralized testing?

Clin. Chem. Lab. Med.

Notes & Tips
Evaluation of cardiac assays on a benchtop chemiluminescent enzyme immunoassay analyzer, PATHFAST