open access

Vol 3, No 3 (2015)
ORIGINAL ARTICLES
Published online: 2015-10-27
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ARCHITECT STAT High Sensitive Troponin I Familiarization Study (FAM) in the Department of Laboratory Medicine, Collegium Medicum, Nicolaus Copernicus University in Bydgoszcz, Poland

Magdalena Krintus, Marek Koziński, Sławomir Manysiak, Lena Nowak-Łoś, Lieselotte Lennartz, Jessie Shih, Ewa Laskowska, Ewa Janiszewska, Jacek Kubica, Grażyna Odrowąż-Sypniewska
DOI: 10.5603/FMC.2015.0004
·
Folia Medica Copernicana 2015;3(3):107-112.

open access

Vol 3, No 3 (2015)
ORIGINAL ARTICLES
Published online: 2015-10-27

Abstract

Background. International guidelines recommend the use of cardiac troponin assays for early detection of acute myocardial infarction. New high-sensitivity assays along with improved precision and sensitivity, are now widely available, accelerating patient’s diagnosis, treatment and invasive therapy. In this study we evaluated analytical performance of the Abbott ARCHITECT STAT high-sensitive troponin-I immunoassay and its 99th percentile upper reference limit.

Methods. We performed the analytical evaluation of the hs-cTnI assay using Abbott ARCHITECT i2000SR immunoanalyzers. Features of the assay including imprecision, detection limits, linearity of dilution, interferences and method comparisons were assessed, as well as the 99th percentile upper reference limits in a cohort of 427 presumably healthy individuals were established.

Results. Total imprecision ranged from 3.1% to 4.7% and was lowest for the medium controls. The observed limit of blank, limit of detection and limit of quantitation assumed values of 0.1, 1.5 and 4.8 ng/L, respectively. Common interferences, sample dilution and carry over did not affect the hs-cTnI results. Hs-cTnI was detectable in 98% of presumably healthy individuals. The 99th percentile values were age and sex dependent in the presumably healthy, but not in the healthy individuals.

Conclusion. The new high-sensitivity troponin-I assay has improved analytical features and may be a valuable diagnostic tool.  

Abstract

Background. International guidelines recommend the use of cardiac troponin assays for early detection of acute myocardial infarction. New high-sensitivity assays along with improved precision and sensitivity, are now widely available, accelerating patient’s diagnosis, treatment and invasive therapy. In this study we evaluated analytical performance of the Abbott ARCHITECT STAT high-sensitive troponin-I immunoassay and its 99th percentile upper reference limit.

Methods. We performed the analytical evaluation of the hs-cTnI assay using Abbott ARCHITECT i2000SR immunoanalyzers. Features of the assay including imprecision, detection limits, linearity of dilution, interferences and method comparisons were assessed, as well as the 99th percentile upper reference limits in a cohort of 427 presumably healthy individuals were established.

Results. Total imprecision ranged from 3.1% to 4.7% and was lowest for the medium controls. The observed limit of blank, limit of detection and limit of quantitation assumed values of 0.1, 1.5 and 4.8 ng/L, respectively. Common interferences, sample dilution and carry over did not affect the hs-cTnI results. Hs-cTnI was detectable in 98% of presumably healthy individuals. The 99th percentile values were age and sex dependent in the presumably healthy, but not in the healthy individuals.

Conclusion. The new high-sensitivity troponin-I assay has improved analytical features and may be a valuable diagnostic tool.  

Get Citation

Keywords

analytical performance, high sensitivity troponin, 99th percentile URL

About this article
Title

ARCHITECT STAT High Sensitive Troponin I Familiarization Study (FAM) in the Department of Laboratory Medicine, Collegium Medicum, Nicolaus Copernicus University in Bydgoszcz, Poland

Journal

Medical Research Journal

Issue

Vol 3, No 3 (2015)

Pages

107-112

Published online

2015-10-27

DOI

10.5603/FMC.2015.0004

Bibliographic record

Folia Medica Copernicana 2015;3(3):107-112.

Keywords

analytical performance
high sensitivity troponin
99th percentile URL

Authors

Magdalena Krintus
Marek Koziński
Sławomir Manysiak
Lena Nowak-Łoś
Lieselotte Lennartz
Jessie Shih
Ewa Laskowska
Ewa Janiszewska
Jacek Kubica
Grażyna Odrowąż-Sypniewska

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