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Analytical evaluation of the new Beckman Coulter Access high sensitivity cardiac troponin I immunoassay
| Content Provider | Scilit |
|---|---|
| Author | Lippi, Giuseppe Ferrari, Anna Gandini, Giorgio Gelati, Matteo Cascio, Claudia Lo Salvagno, Gian Luca |
| Copyright Year | 2017 |
| Abstract | Background: This study was aimed to evaluate the analytical performance of the novel chemiluminescent and fully-automated Beckman Coulter Access hsTnI high-sensitivity immunoassay for measurement of cardiac troponin I (cTnI). Methods: The study, using lithium heparin samples, included assessment of limit of blank (LOB), limit of detection (LOD), functional sensitivity, linearity, imprecision (within run, between-run and total), calculation of 99th percentile upper reference limit (URL) in 175 healthy blood donors (mean age, 36±12 years; 47% women) and comparison with two other commercial cTnI immunoassays. Results: The LOB, LOD and functional sensitivity of Access hsTnI were 0.14, 0.34 and 1.35 ng/L, respectively. The within-run, between-run and total imprecision was 2.2%–2.9%, 4.6%–5.4%, and 5.4%–6.1%, respectively. The linearity was excellent in the range of cTnI values between 0.95 and 4195 ng/L (r=1.00). The 99th percentile URL was 15.8 ng/L. Measurable cTnI values were found in 173/175 healthy subjects (98.9%). Good agreement of cTnI values was found with AccuTnI+3 (r=0.97; mean bias, −9.3%), whereas less satisfactory agreement was found with Siemens Dimension Vista cTnI (r=0.95; mean bias, −55%). Conclusions: The results of our evaluation of the Beckman Coulter Access hsTnI indicate that the analytical performance of this fully-automated immunoassay is excellent. |
| Related Links | http://www.degruyter.com/downloadpdf/j/cclm.2018.56.issue-1/cclm-2017-0350/cclm-2017-0350.xml |
| Ending Page | 161 |
| Page Count | 5 |
| Starting Page | 157 |
| ISSN | 14346621 |
| e-ISSN | 14374331 |
| DOI | 10.1515/cclm-2017-0350 |
| Journal | Clinical Chemistry and Laboratory Medicine (CCLM) |
| Issue Number | 1 |
| Volume Number | 56 |
| Language | English |
| Publisher | Walter de Gruyter GmbH |
| Publisher Date | 2017-11-27 |
| Access Restriction | Open |
| Subject Keyword | Clinical Chemistry and Laboratory Medicine (cclm) Medical Laboratory Technology Immunoassay Method Evaluation Myocardial Infarction Troponin Journal: Clinical Chemistry and Laboratory Medicine (CCLM), Issue- 1-2 |
| Content Type | Text |
| Resource Type | Article |
| Subject | Biochemistry (medical) Clinical Biochemistry |