Analytical Evaluation of an Automated Immunoassay for Cardiac Troponin I: The Vidas Troponin I Assay

Verfasser / Beitragende:
[Francesca Di Serio, Paolo Trerotoli, Gabriella Serio, Lucia Varraso, Nicola Pansini]
Ort, Verlag, Jahr:
2003
Enthalten in:
Clinical Chemistry and Laboratory Medicine, 41/10(2003-09-19), 1363-1368
Format:
Artikel (online)
ID: 378849379
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024 7 0 |a 10.1515/CCLM.2003.209  |2 doi 
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245 0 0 |a Analytical Evaluation of an Automated Immunoassay for Cardiac Troponin I: The Vidas Troponin I Assay  |h [Elektronische Daten]  |c [Francesca Di Serio, Paolo Trerotoli, Gabriella Serio, Lucia Varraso, Nicola Pansini] 
520 3 |a Cardiac troponin I (cTnI) is a sensitive and specific biochemical marker of myocardial damage. We assessed the analytical performance of the Vidas® Troponin I assay (Biomerieux). Controls and serum pools were used to determine the precision, analytical sensitivity and linearity; 97.5 and 99.5 percentiles concentrations were determined from the reference population. Fifty corresponding samples of serum and plasma (lithium-heparin) were tested and the results compared. The in vitro stability of serum and plasma samples was assessed at 20 °C, 4 °C and -20 °C, respectively. Samples of serum were used to assess the agreement between the Vidas® Troponin I method and the revised Dimension RxL cTnI method (Dade-Behring). The total imprecision (CVs) was 13.1-5.2% for concentrations ranging between 0.25 and 19.8 µg/l cTnI. The lower detection limit was <0.1 µg/l. The upper reference limit (97.5 and 99.5 percentiles) was 0.11 µg/l and 0.12 µg/l, respectively (CV >10%). The assay was linear up to 21 g/l. The concentrations in lithium-heparin plasma were higher compared to those of the matched serum samples. The study of the agreement between the Vidas and Dimension RxL cTnI assays showed a total concordance of 96% with a bias value of -0.042. The Vidas® Troponin I test is a fast, precise and sensitive method for the determination of cTnI. Clin Chem Lab Med 2003; 41(10): 13631368 
540 |a Copyright © 2003 by Walter de Gruyter GmbH & Co. KG 
690 7 |a Medical equipment & techniques  |2 nationallicence 
690 7 |a Medical diagnosis  |2 nationallicence 
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700 1 |a Serio  |D Francesca Di  |4 aut 
700 1 |a Trerotoli  |D Paolo  |4 aut 
700 1 |a Serio  |D Gabriella  |4 aut 
700 1 |a Varraso  |D Lucia  |4 aut 
700 1 |a Pansini  |D Nicola  |4 aut 
773 0 |t Clinical Chemistry and Laboratory Medicine  |d Walter de Gruyter  |g 41/10(2003-09-19), 1363-1368  |x 1434-6621  |q 41:10<1363  |1 2003  |2 41  |o cclm 
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950 |B NATIONALLICENCE  |P 700  |E 1-  |a Serio  |D Gabriella  |4 aut 
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