Validation of a New Panel of Automated Chemiluminescence Assays for Anticardiolipin Antibodies in the Screening for Antiphospholipid Syndrome

Kód výsledku v 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>

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

Validation of a New Panel of Automated Chemiluminescence Assays for Anticardiolipin Antibodies in the Screening for Antiphospholipid Syndrome

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

Validation of a New Panel of Automated Chemiluminescence Assays for Anticardiolipin Antibodies in the Screening for Antiphospholipid Syndrome

Popis výsledku anglicky

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.

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FD - Onkologie a hematologie

OECD FORD obor

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Projekt

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Návaznosti

S - Specificky vyzkum na vysokych skolach

Rok uplatnění

2016

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Clinical Laboratory

ISSN

1433-6510

e-ISSN

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Svazek periodika

62

Číslo periodika v rámci svazku

7

Stát vydavatele periodika

DE - Spolková republika Německo

Počet stran výsledku

7

Strana od-do

1309-1315

Kód UT WoS článku

000385813300016

EID výsledku v databázi Scopus

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