A novel immunoassay for the quantization of CYFRA 21-1 in human serum.
J Clin Lab Anal
; 27(4): 277-83, 2013 Jul.
Article
em En
| MEDLINE
| ID: mdl-23852784
ABSTRACT
BACKGROUND:
Cytokeratin 19 fragment antigen (CYFRA 21-1) is used to diagnose and monitor neoplasms. However, the main disadvantages of the currently available CYFRA 21-1 assays include heterogenous technology, being time-consuming, and having low through-put with low insensitivity. This study investigated the use of amplified luminescent proximity homogeneous immunoassay (AlphaLISA) for the quantization of CYFRA 21-1 in human serum.METHODS:
The AlphaLISA kit was developed based on AlphaScreen detection technology with two different anti-CYFRA 21-1 monoclonal antibodies. One was coated on AlphaLISA acceptor beads and the other was biotinylated. Donor beads were coated with streptavidin. The test conditions were optimized and analytical performance was studied.RESULTS:
The measurement range of AlphaLISA CYFRA 21-1 kit was 0.08-500 ng/ml. Assay detection limit was 0.08 ng/ml. The intra- and interassay coefficients of variation were 3.00-9.00% and 4.00-10.00%, respectively. There was no cross-reaction to alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), neuron-specific enolase (NSE), cancer antigen 19-9 (CA19-9), cytokeratins 8 (CK8), and cytokeratins 18 (CK18). The correlation coefficient of blood samples involved was 0.974 between CYFRA 21-1-AlphaLISA assay and a commercial electrochemiluminescence immunoassay (ECLIA) CYFRA 21-1 kit (Roche).CONCLUSIONS:
The AlphaLISA CYFRA 21-1 kit developed in this study had favorable performance characteristics for clinical application with acceptable analytical sensitivity, specificity, and accuracy.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Imunoensaio
/
Queratina-19
/
Medições Luminescentes
/
Antígenos de Neoplasias
Tipo de estudo:
Diagnostic_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2013
Tipo de documento:
Article