title: A new generation of biomarkers tests of myocardial necrosis: the real quality a physician can get from the laboratory.
abstract: BACKGROUND
  Recent guidelines recommended by ESC, ACC, AHA, and WHF concerning biomarkers of myocardial necrosis also apply to the work of clinical laboratories. Methodological modification for tests used in determining cardiac biomarkers reduced the time of the analytical procedure to 9 min (STAT version of the tests). We decided to determine and compare analytical quality of the tests in standard and STAT versions for determining serum level: troponin T, MB isoenzyme of creatine kinase, and myoglobin, as well as to verify whether the TnThs STAT test meets the following requirements: CV<10% at the level close to diagnostic, equal to the 99th percentile of reference population, and turnaround time<60 min.
  
  
  METHODS
  We evaluated real precision and accuracy for both standard and STAT versions of tests as well as the correlation of results of physiological and pathological levels. Additionally, observations of turnaround time were made.
  
  
  RESULTS
  Calculated values of total errors did not exceed the recommended acceptable total error (<20%). Comparable precision of the 2 measurement methods (CV=3.07%) was obtained. A strong correlation (R>0.99) between both variants of tests for all the parameters was confirmed. Thanks to the application of new reagent kit, the percentage of results with turnaround time<60 min increased from 40% to 75% (n=115; p=0.000008).
  
  
  CONCLUSIONS
  The new generation of STAT cardiac biomarkers has high analytical quality and meets international precision requirements. It guarantees high analytical and clinical reliability of results. Use of the STAT version of biomarkers contributes to a significant decrease in turnaround time and allows obtaining a good result of an analysis.
authors: Department of Laboratory Diagnostics and Clinical Biochemistry, Medical University of Łódź, Łódź, Poland.
authors: Rafał Nikodem
authors: RN
authors: Wlazeł
authors: Chair and Department of Cardiology, Medical University of Łódź, Łódź, Poland.
authors: Jarosław
authors: J
authors: Kasprzak
authors: Department of Laboratory Diagnostics and Clinical Biochemistry, Medical University of Łódź, Łódź, Poland.
authors: Marek
authors: M
authors: Paradowski
mesh_terms: D054058:Acute Coronary Syndrome / Q000097:blood / Q000175:diagnosis*; D015415:Biomarkers / Q000378:metabolism*; D019411:Clinical Laboratory Techniques; D052279:Creatine Kinase, MB Form / Q000737:chemistry; D006801:Humans; D007527:Isoenzymes / Q000737:chemistry; D009206:Myocardium / Q000473:pathology*; D009211:Myoglobin / Q000737:chemistry; D009336:Necrosis / Q000473:pathology*; D015203:Reproducibility of Results; D013997:Time Factors; D020107:Troponin T / Q000737:chemistry
chemical_list: D015415:Biomarkers; D007527:Isoenzymes; D009211:Myoglobin; D020107:Troponin T; D052279:Creatine Kinase, MB Form
references: J Am Coll Cardiol. 2000 Sep;36(3):959-69
references: 10987628
references: Eur Heart J. 2012 Mar;33(5):579-86
references: 22267244
references: Clin Chem. 1999 Jul;45(7):1104-21
references: 10388496
references: Scand J Clin Lab Invest Suppl. 1999;230:128-31
references: 10389211
references: Am J Clin Pathol. 2005 Nov;124(5):672-4
references: 16203280
references: Ann Clin Biochem. 2007 Jul;44(Pt 4):343-52
references: 17594781
references: Eur Heart J. 2007 Oct;28(20):2525-38
references: 17951287
references: Clin Chem Lab Med. 2008;46(7):1030-2
references: 18605943
references: J Am Coll Cardiol. 2010 May 11;55(19):2125-8
references: 20447536
references: Acad Emerg Med. 2010 May;17(5):501-7
references: 20536804
references: Clin Chim Acta. 2011 Apr 11;412(9-10):748-54
references: 21219893
references: Heart. 2011 Jun;97(11):940-6
references: 21558070
references: Am J Cardiol. 2011 Sep 1;108(5):639-43
references: 21676369
references: J Am Coll Cardiol. 2011 Sep 20;58(13):1332-9
references: 21920261
references: Eur Heart J. 2011 Dec;32(23):2999-3054
references: 21873419
references: Clin Chem. 2012 Jan;58(1):54-61
references: 21965555
references: Clin Chem. 2012 Jan;58(1):8-10
references: 22125300
references: Clin Chem. 2012 Jan;58(1):39-43
references: 22205772
references: Arch Pathol Lab Med. 2004 Feb;128(2):158-64
references: 14736289