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Clinical Chemistry 46: 560-f-576-f, 2000;
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(Clinical Chemistry. 2000;46:560-576.)
© 2000 American Association for Clinical Chemistry, Inc.


Technical Briefs

Preliminary Evaluation of the Vitros ECi Cardiac Troponin I Assay

Fred S. Apple1,a, Brenda Koplen1 and MaryAnn M. Murakami1

1 Hennepin County Medical Center, Clinical Laboratories MC 812, 701 Park Ave., Minneapolis, MN 55425.
a Author for correspondence: fax 612-904-4229, e-mail fred.apple@co.hennepin.mn.us)

The recently published standards of practice for the use of cardiac marker testing for ruling in and ruling out acute myocardial infarction (AMI) recommend the implementation of cardiac troponin I (cTnI) or T (cTnT) as appropriate markers (1). The purpose of this preliminary study was to analytically and clinically evaluate the Ortho-Clinical Diagnostics (Rochester, NY) Vitros Troponin I immunodiagnostic assay.

The Vitros ECi system uses reagents containing biotinylated monoclonal anti-cTnI antibody and goat polyclonal anti-cTnI antibody labeled with horseradish peroxidase. After an 8-min incubation for reagents and sample in a well precoated with streptavidin, the well is washed and a signal reagent containing horseradish peroxidase substrates is added to detect peroxidase bound to the well by utilizing an enhanced chemiluminescence reaction (2).

The imprecision (as the CV, %) within the same calibration performed according to NCCLS guidelines (3) showed the following results: between-run (n = 80) means over 31 days on 20 occasions were 0.347 µg/L (10%), 0.768 µg/L (5.9%), 4.10 µg/L . . . [Full Text of this Article]


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