European multicenter analytical evaluation of the Abbott ARCHITECT STAT high sensitive troponin I immunoassay
Autor: | Mario Plebani, Marek Koziński, Pascal Boudry, Maria B. Sandberg, Grazyna Sypniewska, Guillaume Lefèvre, Jessie Shih, Martina Zaninotto, Lieselotte Lennartz, Johannes Lotz, Karl J. Lackner, Wolfgang Schratzberger, Øyvind Skadberg, Nuria Estañ Capell, Ursula Köller, Ahmed Taoufik Chargui, Antonio Mora Herranz, Magdalena Krintus, Mads Nybo |
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Jazyk: | angličtina |
Rok vydání: | 2014 |
Předmět: |
high sensitive troponin
Adult Male analytical performance Pathology medicine.medical_specialty Adolescent analytical evaluation Clinical Biochemistry Sensitivity and Specificity Young Adult Troponin I Humans Medicine Sample Type Aged Blood coagulation test Aged 80 and over Immunoassay Detection limit Chromatography medicine.diagnostic_test business.industry Biochemistry (medical) General Medicine Middle Aged musculoskeletal system Europe Multicenter study Method comparison High sensitivity troponin cardiovascular system Female Blood Coagulation Tests Reagent Kits Diagnostic Laboratories business 99th percentile upper reference limit |
Zdroj: | Krintus, M, Kozinski, M, Boudry, P, Capell, N E, Köller, U, Lackner, K, Lefèvre, G, Lennartz, L, Lotz, J, Herranz, A M, Nybo, M, Plebani, M, Sandberg, M B, Schratzberger, W, Shih, J, Skadberg, Ø, Chargui, A T, Zaninotto, M & Sypniewska, G 2014, ' European multicenter analytical evaluation of the Abbott ARCHITECT STAT high sensitive troponin I immunoassay ', Clinical Chemistry and Laboratory Medicine, vol. 52, no. 11, pp. 1657-1665 . https://doi.org/10.1515/cclm-2014-0107 |
Popis: | BACKGROUND: International recommendations highlight the superior value of cardiac troponins (cTns) for early diagnosis of myocardial infarction along with analytical requirements of improved precision and detectability. In this multicenter study, we investigated the analytical performance of a new high sensitive cardiac troponin I (hs-cTnI) assay and its 99th percentile upper reference limit (URL).METHODS: Laboratories from nine European countries evaluated the ARCHITECT STAT high sensitive troponin I (hs-TnI) immunoassay on the ARCHITECT i2000SR/i1000SR immunoanalyzers. Imprecision, limit of blank (LoB), limit of detection (LoD), limit of quantitation (LoQ) linearity of dilution, interferences, sample type, method comparisons, and 99th percentile URLs were evaluated in this study.RESULTS: Total imprecision of 3.3%-8.9%, 2.0%-3.5% and 1.5%-5.2% was determined for the low, medium and high controls, respectively. The lowest cTnI concentration corresponding to a total CV of 10% was 5.6 ng/L. Common interferences, sample dilution and carryover did not affect the hs-cTnI results. Slight, but statistically significant, differences with sample type were found. Concordance between the investigated hs-cTnI assay and contemporary cTnI assay at 99th percentile cut-off was found to be 95%. TnI was detectable in 75% and 57% of the apparently healthy population using the lower (1.1 ng/L) and upper (1.9 ng/L) limit of the LoD range provided by the ARCHITECT STAT hs-TnI package insert, respectively. The 99th percentile values were gender dependent.CONCLUSIONS: The new ARCHITECT STAT hs-TnI assay with improved analytical features meets the criteria of high sensitive Tn test and will be a valuable diagnostic tool. |
Databáze: | OpenAIRE |
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