Evaluation of the new ImmuliteTurbo cTnI assay and the original immulite cTnI assay.
Scand J Clin Lab Invest
; 61(8): 593-601, 2001.
Article
em En
| MEDLINE
| ID: mdl-11768318
ABSTRACT
OBJECTIVES:
An analytical and clinical evaluation of cTnI on the ImmuliteTurbo system with 15 min assay time compared to 45 min with the original Immulite assay is presented. METHODS ANDDESIGN:
Detection limit, functional sensitivity, AMI decision limit, assay linearity, influence of sample material (serum, heparin, citrate and EDTA plasma), interference, analytical and clinical method comparison studies were performed.RESULTS:
Functional sensitivity (at CV 20%) was 0.35 compared to 0.23 microg/L for the original assay. AMI decision limit (99th percentile of a reference control group) was 0.48 microg/L for both assays. In patients with acute coronary syndromes, chronic renal failure or pulmonary embolism the assays showed concordant results in 87.2-96.5%. Differing results were only found around the cut-off level and were attributed to assay imprecision.CONCLUSION:
The new assay is sensitive for the determination of cTnI, shows comparable results to the original assay version and is easy to perform within 15 min.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Imunoensaio
/
Isquemia Miocárdica
/
Troponina I
/
Angina Instável
Tipo de estudo:
Diagnostic_studies
/
Evaluation_studies
/
Prognostic_studies
Limite:
Adolescent
/
Adult
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Ano de publicação:
2001
Tipo de documento:
Article