Technology | October 18, 2011

Randox Launches Acusera Troponin T Assay Quality Control

October 18, 2011 — Randox Laboratories announced the launch of a high sensitivity troponin T control. The new control allows clinical laboratories to more accurately monitor and assess the performance of their high sensitivity troponin T (hsTnT) assay.

Cardiac troponins are widely used in the detection of myocardial infarction (MI). Even small elevations in its levels indicate damage to the heart and possible MI. Both the European Society of Cardiology (ESC) and the American College of Cardiology (ACC) recommend using a highly sensitive troponin assay with excellent precision (less than 10 percent CV) at the 99th percentile of the reference range.

Before now, suitable control materials for hsTnT with target values sufficiently close to the 99th percentile of the reference range (14ng/L) were unavailable. The recent launch of the Randox Acusera High Sensitivity Troponin T Control now allows laboratories to more accurately monitor and assess the performance of their hsTnT assay.

The ultra low troponin T levels found in the Randox control are significantly lower than those found in other manufacturers’ quality control (QC) material. Target values are generally around 16.5ng/l (range 12.4 – 20.6ng/l) and are closest to the 14ng/ml cut off.

The Acusera control has a shelf life of up to four years, meaning the same lot of control material can be used for longer; this reduces the problems associated with lot crossovers. A reconstituted stability of five days at +2 - +8 degrees Celsius or four weeks at -20 degrees Celsius minimizes unnecessary waste and provides significant cost savings.

Randox also manufactures a liquid cardiac control with assayed values for 10 cardiac markers including BNP, CK-MB, D-dimer, Digoxin, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I and Troponin T. The control is liquid ready to use for added convenience and ease of use. Three levels are available spanning the complete clinical range with cut off levels for both Troponin I and T in line with international recommendations.

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