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Letters to the Editor |
1 Laboratorio Analisi Chimico Cliniche 1 Azienda Ospedaliera Spedali Civili, Brescia, Italy
2 Laboratorio Analisi Ospedale Civile, Alba (CN), Italy
3 Patologia Clinica Ospedale Civile, Monselice (PD), Italy
4 Laboratorio Analisi Ospedale Vincenzo Monaldi, Napoli, Italy
5 Patologia Clinica Ospedale Civile, Piove di Sacco (PD), Italy
6 Laboratorio Analisi Istituto di Fisiologia Clinica Consiglio Nazionale delle Ricerche, Pisa, Italy
7 Laboratorio Analisi Ospedale Civile Borgo Trento, Verona, Italy
aAddress correspondence to this author at: Laboratorio Analisi Chimico Cliniche 1, Azienda Ospedaliera Spedali Civili, 25125 Brescia, Italy. Fax 39-030-3995369; e-mail panteghi@bshosp.osp.unibs.it.
| The first 20% of the full text of this article appears below. |
To the Editor:
The redefined biochemical criterion proposed to diagnose myocardial infarction (MI) necessitates the availability of highly sensitive and precise cardiac troponin assays (1). In general, a substantial improvement in the analytical performance is offered by the newer assays. In this multicenter study, we evaluated one of these improved cardiac troponin I (cTnI) assays, performed on the AIA 21 immunoassay system (TOSOH Corp.), using criteria tailored in accordance with IFCC recommendations (2).
The AIA-Pack second-generation cTnI assay uses a combination of two monoclonal antibodies, one directed to amino acids 4149 of the cTnI molecule and another directed to amino acids 8791. A human cardiac ternary troponin ITC complex is used as calibration antigen. The minimum detectable cTnI concentration was defined as the value corresponding to a signal 3 SD greater than the mean of 20 replicates of the zero calibrator in a single run. Buffered stock solutions of both free cTnI and troponin IC complex (Scripps Laboratories) were serially diluted in AIA-Pack diluent and tested to estimate the degree of equimolarity. Four cTnI-rich serum pools (native concentrations,
2.5 to
100 µg/L) were serially diluted with serum pools having cTnI below the detection limit or with the manufacturers diluent. The undiluted sample and four dilutions were assayed in duplicate, and the curve obtained was tested for linearity (3).
To evaluate imprecision, LiquichekTM control sera (three concentrations; Bio-Rad Laboratories) were tested in duplicate in one run per day for 20 days, using two reagent lots and two calibrations. Seven serum pools (cTnI concentrations, 0.02, 0.05, 0.10, 0.15,
The following articles in journals at HighWire Press have cited this article:
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M. Panteghini Selection of Antibodies and Epitopes for Cardiac Troponin Immunoassays: Should We Revise Our Evidence-Based Beliefs? Clin. Chem., May 1, 2005; 51(5): 803 - 804. [Full Text] [PDF] |
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