Human high sensitivity control material to
facilitate quality assurance of biochemical
tests for cardiac troponin T
Wong W-Y., Shanks A., Spon-Smith C., Rodríguez M.L., Campbell J., FitzGerald S.P.
Randox Laboratories Limited
Diamond Road, Crumlin, County Antrim, N. Ireland, BT29 4QY, United Kingdom.
The human control material contained cTnT at levels around the cut-off of 14 ng/L
Reconstituted open vial stability over 5 days at +2°C to +8°C
Analyte Day 0 Day 1 % Recovery from Day 0 Day 0 Day 4 % Recovery from Day 0 Day 0 Day 5 % Recovery from Day 0
cTnT (ng/L) 19.16 18.73 98 17.82 18.79 105 20.34 19.59 104
Analyte Day 0 Day 3 % Recovery from Day 0 Day 0 Day 4 % Recovery from Day 0 Day 0 Day 5 % Recovery from Day 0
cTnT (ng/L) 21.14 20.64 98 19.46 19.42 100 20.31 20.02 99
Reconstituted open vial stability over 5 days at +2°C to +8°C after 4 weeks at -20°C
Analyte Lyophilised -80°C Lyophilised 4 years +2°C to +8°C % Recovery
cTnT (ng/L) 19.6 19.2 98
Shelf life stability
In the diagnosis of myocardial infarction an increased value of cardiac troponin in blood is
defined as a measurement exceeding the 99th
percentile of a normal reference population
and at this percentile the optimal precision should be defined as <10%.1
of the accuracy and precision of the biochemical tests for cardiac troponin require quality
control material.This study reports a human control material for cardiac troponin
T (cTnT) presenting values allowing the assessment of the analytical performance at
the low end of the assay range which is also advantageous for the earlier detection of
The human control material contained cTnT at levels around the cut-off of 14 ng/L and
was dispensed into 3 mL glass vials and lyophilised.
as the %recovery of cTnT over a period of 5 days when stored at +2°C to +8°C related
to day 0 (+2°C to +8°C) and a period of 5 days when stored at +2°C to +8°C after 4
weeks at -20°C related to day 0. Shelf life was determined as the %recovery of cTnT from
lyophilised material stored at +2°C to +8°C over a period of 4 years related to material
stored at -80°C.
The human lyophilised high sensitivity troponin T control with target values around the
cut-off 14 ng/L presented reconstituted stability of 5 days (+2°C to +8°C) and 4 weeks
(-20°C).Shelf life was determined as 4 years.This control material is suitable for monitoring
the performance of high sensitivity troponin T assays facilitating earlier detection of this
Randox Laboratories Limited, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom
+44 (0) 28 9442 2413 +44 (0) 28 9445 2912 email@example.com randoxqc.com
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1. Thygesen K,Alpert JS,White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction. Universal definition of myocardial infarction. Eur.Heart J. 2007, 28(20): 2525-2538.
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