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Tni ultra

Manufactured by Siemens
Sourced in Germany

The TnI-Ultra is a laboratory equipment product by Siemens. It is used for the quantitative determination of cardiac troponin I (cTnI) in human serum and plasma. The cTnI is a cardiac-specific protein that is released into the bloodstream when the heart muscle is damaged, such as during a heart attack.

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6 protocols using tni ultra

1

Cardiac Troponin I Measurement Protocol

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All measurements of TnI were performed in the same laboratory using the contemporary immunoassay technique (TnI-Ultra from Siemens, Advia Centaur). According to the manufacturers, the upper and lower detection limits were 0.006 μg/ml and > 50 μg/ml. respectively. Levels below the detection limit were given a value of 0 and those above 50 μg/ml a value of 50. The reference range for a positive cTnI test was > 0.039 μg/ml, corresponding to the 99th percentile of a reference control group, with a coefficient of variation < 10%.
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2

Cardiac Troponin Assessment for PET Imaging

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All patients underwent serial assessment of serum cardiac troponin using the clinically-available local assay within 14 days prior to PET imaging. Serial assessment involved three consecutive blood draws approximately every 8 hours over a 24-hour period. From 2006 to 2011, 3 different troponin assays were sequentially utilized at BWH: cTnI (Siemens Healthcare Diagnostics, initially introduced by Bayer HealthCare LLC, Diagnostics Division) with reference range <0.10 µg/L reflecting a 99th-percentile cutoff point of 0.16 µg/L; TnI-Ultra (Siemens Healthcare Diagnostics) with reference range <0.04 µg/L reflecting a 99th-percentile cutoff point of 0.04 µg/L; and cTnT fourth-generation Elecsys (Roche Diagnostics) with reference range <0.01 µg/L reflecting a 99th-percentile cutoff point of less than 0.01 µg/L.24 (link), 25 (link) Values above the reference range indicate a positive troponin. The peak value from serial assessment for each patient was used.
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3

Evaluation of Ultrasensitive Troponin in ED Patients

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This study was performed at a tertiary care academic medical and trauma center with 56,000 adult ED patient visits a year using a sensitive contemporary troponin biomarker for the evaluation of MI. Prior to the initiation of this retrospective chart review, it was approved by the hospital human research committee. The study period was March 1–July 31, 2007. The study population included all patients ≥18 years of age with a positive (≥0.05 μg/L) initial ultrasensitive cTnI (TnI-Ultra, Siemens Healthcare Diagnostics, Tarrytown, New York) [8 (link), 9 (link)] during their ED evaluation. Patients presenting in cardiac arrest were excluded. Typical practice in the ED at this time was to test appropriate patients for a cTn elevation upon initial evaluation and then 6 hours after presentation. Patients with a cTn elevation at first measurement were included. Results were obtained from the laboratory information system and merged, with the associated patient data from the electronic medical record system, in Microsoft Excel.
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4

Cardiovascular Biomarker Measurement Protocol

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The blood samples were obtained at baseline. Venous blood was drawn from the basilic vein. In the analysis, the peripheral blood count was marked with CELL-DYN Ruby (Abbott Diagnostics, Santa Clara, CA, USA). Fibrinogen, D-dimer, aPTT and INR were determined using STACompact Max (Diagnostica Stago, Parsippany, NJ, USA). Creatinine, total cholesterol, high-density lipoproteins, and triglycerides were analyzed using a photometric test (Roche Diagnostics GmbH, Mannheim, Germany).
The assessment of cardiac troponin involved the use of two assays: (a) a traditional immunoassay technique carried out from January 2012 to September 2014 (TnI-Ultra from Siemens, Advia Centaur, Deerfield, IL, USA), featuring a limit of detection of 6 pg/mL (0.006 ng/mL), a 99th percentile reference limit of 40 pg/mL (0.04 ng/mL), and a total imprecision of 10% at a concentration of 30 pg/mL (0.03 ng/mL) [23 (link)]; (b) the blood samples taken between October 2014 and December 2016 were analyzed by high sensitivity assays for cTnT (Roche Diagnostics, Basel, Switzerland), which have a limit of detection at 5 ng/L and a 99th percentile reference limit of 14 ng/L, with a total imprecision of 10% at a concentration of 13 ng/L.
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5

Cardiac Troponin I Measurement Protocol

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Blood was drawn at study enrollment in both cohorts. Routine laboratory parameters were measured directly after blood withdrawal by standardized methods. Plasma and serum samples were collected, centrifuged, and frozen at −80 °C. A commercial contemporary sensitive assay (TnI-Ultra, Siemens Healthcare Diagnostics, Germany) was used to determine cTnI (cs-cTnI) on an ADVIA Centaur XP system. According to the manufacturer, this assay has a measuring range of 6–50,000 ng/L and coefficient of variation of less than 10% at 30 ng/L. The 99th percentile reference limit based on a healthy population is 40 ng/L26 (link).
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6

Wide QRS Complex Biomarker Assessment

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Blood was drawn directly upon admission. Routine laboratory parameters, including in-house troponin, C-reactive protein, creatinine, and creatinkinase-MB were measured immediately after blood withdrawal by standardized methods. Additionally, ethylenediaminetetraacetic acid plasma, citrate plasma, and serum samples were collected, centrifuged, and frozen at -80°C.
Investigational cTnI was determined using a commercial contemporary sensitive assay (TnI-Ultra, Siemens Healthcare Diagnostics, Germany) on an ADVIA Centaur XP system with measuring range of 6–50000 ng/L and lowest concentration with coefficient of variation of 10% or less at 30ng/L. The reference limit based on the 99th percentile for a healthy population is 40ng/L [25 (link)].
B-type natriuretic peptide (BNP) was assayed on the ARCHITECT i System (Abbott Diagnostics, Germany) with analytical sensitivity of ≤10pg/ml and measuring range of 0–5000 pg/ml. Estimated glomerular filtration rate (eGFR) was calculated based on the abbreviated modification of diet in renal disease formula (MDRD)[27 (link)]. Based on availability of sample volume, BNP and cTnI levels were available in 417 and data on eGFR in 425 patients of 427 patients presenting with wide QRS complex.
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