A Multi-Center Analytical Evaluation of the ARCHITECT STAT High Sensitive Troponin-I Assay
Magdalena Krintus1, Pascal Boudry2, Nuria Estan3, Ursula Köller4, Guillaume Lefèvre5, Mads Nybo6, Lieselotte Lennartz7,*, Mario Plebani8, Jessie Shih9, Øyvind Skadberg10, Johannes Lotz11
1Department of Laboratory Medicine, Nicolaus Copernicus University, Bydgoszcz, Poland, 2Department of Clinical Biology, CHR Mons-Hainaut, Mons, Belgium, 3Department of Clinical Biochemistry, Dr. Peset University Hospital, Valencia, Spain, 4Institute for Laboratory Diagnostics, Hospital Hietzing, Vienna, Austria, 5Department of Biochemistry and Hormonology , Hôpital Tenon, Paris, France, 6Department of Clinical Biochemistry and Pharmacology, Odense University Hospital, Odense, Denmark, 7Scientific Affairs, Abbott Laboratories, Wiesbaden, 8Department of Laboratory Medicine, University Hospital, Padova, Germany, 9Global Scientific Affairs, Abbott Laboratories, Abbott Park, United States, 10Department of Clinical Biochemistry , Stavanger University Hospital, Stavanger, Norway, 11Department of Laboratory Medicine, Mainz University Hospital, Mainz, Germany
Introduction: Troponin is the preferred biomarker for the diagnosis of acute myocardial infarction, with the recommended cutoff at the upper reference limit (URL) or 99th percentile value with precision of <10
Objectives: Study evaluated the analytical performance of a new high sensitivity troponin-I assay on the ARCHITECT instrument.
Methods: The high sensitivity troponin-I assay is a double monoclonal, sandwich assay with chemiluminescent detection. 9 laboratories in Europe participated in this study using either ARCHITECT i2000SR or i1000SR instruments Total precision, limit of blank (LoB), Limit of detection (LoD), limit of quantitation (LoQ), linearity and interference were determined following guidance from CLSI documents . Method comparison was performed using the ARCHITECT STAT Troponin-I assay (contemporary TnI) as the referent method and 2598 samples that spanned the dynamic range of the assays. The 99th percentile URL was determined using 1769 samples from healthy populations or blood donors from seven countries. Ethics approval or waiver was received for specimens collected for the reference interval and method comparison studies.
Results: Precision ranged from 1.5 to 8.9% using the manufacturer’s controls. The lowest concentrations corresponding to a total CV of 10% was 5.6 ng/L. Common interferences did not affect the hsTnI results. The overall 99th percentile URL was determined to be 19.3 ng/L and was higher in men (27.0 ng/L) than in women (11.4 ng/L). Troponin was detectable in <50 % of the apparently healthy population. Concordance between the investigated hsTnI assay and the contemporary TnI assay at the 99th percentile cutoff was found to be 95%.
Conclusion: These results demonstrate that the ARCHITECT STAT high sensitive troponin-I assay is a precise and highly sensitive method for measuring troponin I on a high throughput analyzer. This new assay meets the criteria of a high sensitivity troponin test with the 10% CV concentration below the 99th percentile URL.
Keywords: Biomarker, Cardiovascular