Validation of a New Panel of Automated Chemiluminescence Assays for Anticardiolipin Antibodies in the Screening for Antiphospholipid Syndrome
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15110%2F16%3A33159427" target="_blank" >RIV/61989592:15110/16:33159427 - isvavai.cz</a>
Result on the web
<a href="http://dx.doi.org/10.7754/Clin.Lab.2015.151129" target="_blank" >http://dx.doi.org/10.7754/Clin.Lab.2015.151129</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.7754/Clin.Lab.2015.151129" target="_blank" >10.7754/Clin.Lab.2015.151129</a>
Alternative languages
Result language
angličtina
Original language name
Validation of a New Panel of Automated Chemiluminescence Assays for Anticardiolipin Antibodies in the Screening for Antiphospholipid Syndrome
Original language description
Background: Antibodies Anticardiolipin (aCL) and anti-β2-glycoprotein I (aβ2GPI) are two of three laboratory criteria of antiphospholipid syndrome (APS). All of assays of antiphospholipid antibodies (aPL), coagulation as- says as well as ELISAs, show methodological shortcomings, that affect their sensitivity and specificity. Therefore, we decided to validate these parameters for a new chemiluminescent examination (CLIA). Methods: aCL and aβ2GPI antibodies were measured by ELISAs (AIDA, Bad Kruznach, Germany) and aβ2GPI with CLIA kits (Werfen, Barcelona, Spain). Results: When we evaluated both assays, the coefficient of variation for CLIA was slightly lower (9.04 - 12.74%) than for ELISA (11.05 - 15.3%) and the LOD was 0.2 IU/L. The dilution series showed significant linearity for all CLIA methods, aCL IgG, aCL IgM, aβ2GPI IgG, and aβ2GPI IgM (0 - 3000 IU/L), and method comparison stud- ies revealed good agreement with the currently used ELISA (Kappa values ranging 0.534 - 0.936) without deter- mination of aβ2GPI IgG. The determination aβ2GPI IgG by CLIA method shows higher positivity in 31 samples. These new aCL IgG, aCL IgM, aβ2GPI IgG, and aβ2GPI IgM tests have excellent analytical characteristics and allow fully automated and simultaneous analysis on an analyzer. Conclusions: Chemiluminescent determination of an automated analyzer can improve the fundamental parame- ters of tests such as reproducibility between laboratories.
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FD - Oncology and haematology
OECD FORD branch
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Result continuities
Project
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Continuities
S - Specificky vyzkum na vysokych skolach
Others
Publication year
2016
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Clinical Laboratory
ISSN
1433-6510
e-ISSN
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Volume of the periodical
62
Issue of the periodical within the volume
7
Country of publishing house
DE - GERMANY
Number of pages
7
Pages from-to
1309-1315
UT code for WoS article
000385813300016
EID of the result in the Scopus database
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