The heart of the matter – LGC improves therapeutic drug monitoring for cardiac arrhythmia
08 Dec 2011
New digoxin matrix reference materials ensure optimum therapeutic effect for improved patient care
LGC, the UK’s designated National Measurement Institute for chemical and bioanalytical measurement, has developed two new clinical reference materials for digoxin; a drug instrumental in the treatment of congestive heart failure and cardiac arrhythmia.
Digoxin has a narrow therapeutic range in humans - above the therapeutic range and digoxin is highly toxic, below and the treatment is ineffective. You may remember the scene in Casino Royale where James Bond tries to defibrillate himself after being poisoned by a Vesper Martini tainted with digoxin. He develops ventricular tachycardia, an increased rhythm of the heart, which can lead to ventricular fibrillation and sudden death.
LGC’s two new reference materials, which closely match the upper and lower levels for digoxin monitoring, are both certified as European Reference Materials (ERM®) and made under LGC’s accreditation to ISO Guide 34 for the production of reference materials. They are intended for use by clinical laboratories for determining digoxin levels in human serum through method validation and performance monitoring of methods, providing an effective means of measurement traceability.
Gill Holcombe, Head of Reference Material Production at LGC explains: “Assays for determining levels of digoxin in human serum are independently calibrated but without traceability to an accepted high order reference material. This means that concentration values may not be comparable between different methods or hospital laboratories, posing potential risks to patients. LGC’s new reference materials will improve confidence in measurement, helping clinicians to ensure optimum therapeutic effect and minimise the occurrence of adverse events.”
The reference materials, ERM®-DA200a Frozen Human Serum – Digoxin, High Level and ERM®-DA201a Frozen Human Serum - Digoxin, Low Level are available from LGC Standards (www.lgcstandards.com), the division of LGC that provides products and services to improve measurement in the laboratory. For prices and ordering information, please email: firstname.lastname@example.org or call +44 (0)20 8943 8480.
This work was funded by the UK National Measurement System.