Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

ACB Focus 2015 Poster

471 views

Published on

Randox Quality Control Poster for the Association for Clinical Biochemistry and Laboratory Medicine National Meeting in Cardiff.

Published in: Healthcare
  • Be the first to comment

  • Be the first to like this

ACB Focus 2015 Poster

  1. 1. W QUALITY CONTROL 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 cTnT levels Results Introduction 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 The monitoring 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 cTnT. Methodology 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. Reconstitutedstabilityandreconstitutedstabilityafterfreezingweredeterminedrespectively 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. Conclusion 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 biomarker. Randox Laboratories Limited, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom +44 (0) 28 9442 2413 +44 (0) 28 9445 2912 marketing@randox.com randoxqc.com QUALITY CONTROL For more information please visit booth number 7 Reference 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. Complete QC solutions for results you can trust 13/051/622RDS 13/050/622RDS 14/063/622RDS

×