title: Evaluation of analytical performance and comparison of clinical results of the new generation method AccuTnI+3 for the measurement of cardiac troponin I using both patients and quality control plasma samples.
abstract: The study aims are to evaluate the analytical performance and the clinical results of the chemiluminescent Access AccuTnI+3 immunoassay for the determination of cardiac troponin I (cTnI) with DxI 800 and Access2 platforms and to compare the clinical results obtained with this method with those of three cTnI immunoassays, recently introduced in the European market. The limits of blank (LoB), detection (LoD), and quantitation (LoQ) at 20% CV and 10% CV were 4.5 ng/L and 10.9 ng/L, 17.1 and 30.4 ng/L, respectively. The results of STAT Architect high Sensitive TnI (Abbott Diagnostics), ADVIA Centaur Troponin I Ultra (Siemens Healthcare Diagnostics), ST AIA-Pack cTnI third generation (Tosoh Bioscience), and Access AccuTnI+3 (Beckman Coulter Diagnostics) showed very close correlations (R ranging from 0.901 to 0.994) in 122 samples of patients admitted to the emergency department. However, on average there was a difference up to 2.4-fold between the method measuring the highest (ADVIA method) and lowest cTnI values (AccuTnI+3 method). The consensus mean values between methods ranged from 6.2% to 29.6% in 18 quality control samples distributed in an external quality control study (cTnI concentrations ranging from 29.3 ng/L to 1557.5 ng/L). In conclusion, the results of our analytical evaluation concerning the AccuTnI+3 method, using the DxI platform, are well in agreement with those suggested by the manufacturer as well as those reported by some recent studies using the Access2 platform. Our results confirm that the AccuTnI+3 method for the Access2 and DxI 800 platforms is a clinically usable method for cTnI measurement.
authors.affiliation: Fondazione CNR Regione Toscana G. Monasterio, Pisa, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Storti
authors.affiliation: Scuola Superiore Sant'Anna, Pisa, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Masotti
authors.affiliation: Fondazione CNR Regione Toscana G. Monasterio, Pisa, Italy.
authors.forename: Concetta
authors.initials: C
authors.lastname: Prontera
authors.affiliation: Dipartimento di Ricerca Traslazionale e delle Nuove Tecnologie in Medicina e Chirurgia, Università di Pisa, Pisa, Italy; Fondazione CNR Regione Toscana G. Monasterio, Pisa, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Franzini
authors.affiliation: Emergency Department, Ospedale Civile Santi Antonio e Biagio e Cesare Arrigo di Alessandria, Alessandria, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Buzzi
authors.affiliation: Emergency Department, Ospedale Civile Santi Antonio e Biagio e Cesare Arrigo di Alessandria, Alessandria, Italy.
authors.forename: Ivo
authors.initials: I
authors.lastname: Casagranda
authors.affiliation: Scuola Superiore Sant'Anna, Pisa, Italy.
authors.forename: Enrica
authors.initials: E
authors.lastname: Ciofini
authors.affiliation: CNR Institute of Clinical Physiology and QualiMedLab, Pisa, Italy.
authors.forename: Gian Carlo
authors.initials: GC
authors.lastname: Zucchelli
authors.affiliation: CNR Institute of Clinical Physiology and QualiMedLab, Pisa, Italy.
authors.forename: Rudina
authors.initials: R
authors.lastname: Ndreu
authors.affiliation: Fondazione CNR Regione Toscana G. Monasterio, Pisa, Italy; Scuola Superiore Sant'Anna, Pisa, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Passino
authors.affiliation: Fondazione CNR Regione Toscana G. Monasterio, Pisa, Italy; Scuola Superiore Sant'Anna, Pisa, Italy. Electronic address: clerico@ftgm.it.
authors.forename: Aldo
authors.initials: A
authors.lastname: Clerico
mesh_terms: D006801:Humans; D007118:Immunoassay; D008163:Luminescent Measurements; D011786:Quality Control; D019210:Troponin I / Q000097:blood*
chemical_list: D019210:Troponin I
keywords: Automated immunometric assays; Cardiac troponins; High sensitive methods; Myocardial infarction