Evaluation of analytical performance of a new high-sensitivity immunoassay for cardiac troponin I.

Abstract:

BACKGROUND:The study aim was to evaluate and compare the analytical performance of the new chemiluminescent immunoassay for cardiac troponin I (cTnI), called Access hs-TnI using DxI platform, with those of Access AccuTnI+3 method, and high-sensitivity (hs) cTnI method for ARCHITECT platform. METHODS:The limits of blank (LoB), detection (LoD) and quantitation (LoQ) at 10% and 20% CV were evaluated according to international standardized protocols. For the evaluation of analytical performance and comparison of cTnI results, both heparinized plasma samples, collected from healthy subjects and patients with cardiac diseases, and quality control samples distributed in external quality assessment programs were used. RESULTS:LoB, LoD and LoQ at 20% and 10% CV values of the Access hs-cTnI method were 0.6, 1.3, 2.1 and 5.3 ng/L, respectively. Access hs-cTnI method showed analytical performance significantly better than that of Access AccuTnI+3 method and similar results to those of hs ARCHITECT cTnI method. Moreover, the cTnI concentrations measured with Access hs-cTnI method showed close linear regressions with both Access AccuTnI+3 and ARCHITECT hs-cTnI methods, although there were systematic differences between these methods. There was no difference between cTnI values measured by Access hs-cTnI in heparinized plasma and serum samples, whereas there was a significant difference between cTnI values, respectively measured in EDTA and heparin plasma samples. CONCLUSIONS:Access hs-cTnI has analytical sensitivity parameters significantly improved compared to Access AccuTnI+3 method and is similar to those of the high-sensitivity method using ARCHITECT platform.

journal_name

Clin Chem Lab Med

authors

Masotti S,Prontera C,Musetti V,Storti S,Ndreu R,Zucchelli GC,Passino C,Clerico A

doi

10.1515/cclm-2017-0387

subject

Has Abstract

pub_date

2018-02-23 00:00:00

pages

492-501

issue

3

eissn

1434-6621

issn

1437-4331

pii

/j/cclm.ahead-of-print/cclm-2017-0387/cclm-2017-03

journal_volume

56

pub_type

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