title: Evaluation of cardiac assays on a benchtop chemiluminescent enzyme immunoassay analyzer, PATHFAST.
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.
authors.affiliation: Research and Development Department, Mitsubishi Kagaku Iatron, 1144 Ohwadashinden, Yachiyo, Chiba 276-0046, Japan. kurihara.takashi@mb.medience.co.jp
authors.forename: Takashi
authors.initials: T
authors.lastname: Kurihara
authors.forename: Atsushi
authors.initials: A
authors.lastname: Yanagida
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Yokoi
authors.forename: Atsushi
authors.initials: A
authors.lastname: Koyata
authors.forename: Takeshi
authors.initials: T
authors.lastname: Matsuya
authors.forename: Junichi
authors.initials: J
authors.lastname: Ogawa
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Okamura
authors.forename: Daishi
authors.initials: D
authors.lastname: Miyamoto
mesh_terms: D006801:Humans; D007124:Immunoenzyme Techniques / Q000295:instrumentation*; D008163:Luminescent Measurements / Q000295:instrumentation*; D009206:Myocardium / Q000737:chemistry* / Q000378:metabolism; D019210:Troponin I / Q000032:analysis / Q000378:metabolism
chemical_list: D019210:Troponin I