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Striving for Greater Traceability in Clinical Laboratory Testing
An article published in the October, 2009, issue of Clinical Laboratory News highlighted
the pursuit of greater traceability in clinical laboratory testing. The article
noted the movement of clinical labs towards the establishment of internationally
recognized methods and materials for the promotion of traceability and harmonization
among their testing methods and analytical results. (http://www.aacc.org/publications/cln/2009/october/Pages/CoverStory1Oct09.aspx)
Metrology, a discipline focused on the science of measurement, promotes traceability
through the use of well-defined reference materials which serve as the gold standard
in measurement of an analyte. In clinical testing, traceability involves the comparison
of a patient’s test results to the gold standard reference material through an unbroken
chain of documentation. Tying assays to the same reference materials and methods
promotes harmonization of clinical laboratory practices worldwide.
Several organizations and governments continue to lead initiatives for promoting
traceability in clinical testing. The Joint Committee for Traceability in Laboratory
Medicine (JCTLM), an international consortium formed in 2002, recognizes and publishes
reference materials and methods for the traceability of calibrators. The European
Union, through its In Vitro Diagnostics (IVD) Directive, requires all manufacturers
to provide traceability for their assay kit calibrators, when available. The promotion
and execution of these initiatives continue to drive harmonization or standardization
of assays in clinical testing.
One challenge to harmonization efforts involves different regulatory systems among
countries around the world. While the regulatory system in the US is vastly different
from that in the EU, US Food and Drug Administration (FDA) officials have provided
strong support for encouraging traceability in new filings for regulatory approval
of IVD devices and assays. Other difficulties include more challenging analytes
for which acceptable reference materials and/or methods do not exist. These various
challenges require combined efforts from the clinical lab community, instrument
manufacturers, and world governments in order to achieve further gains in traceability
and harmonization of clinical laboratory methods and practices.
Cerilliant’s certified spiking solutionsTM offer traceability to SI units
and NIST and are manufactured to the highest industry standards. Cerilliant’s certified
solutions are gravimetrically prepared using fully qualified balances calibrated
using NIST traceable weights. Routine calibration verification is performed weekly
and prior to each use. Each balance has been assigned a minimum weighing by Mettler
Toledo taking into consideration the balance and installed environmental conditions
to ensure weighing complies with USP tolerances of no more than 0.1% relative error.
Validated processes are used for the preparation and dispensing and all work is
fully documented in a detailed batch record. Each certified solution is analytically
verified post manufacture to ensure compliance with established tolerances, we
provide a comprehensive certificate of analysis with every product. Our quality
credentials include accreditations to ISO Guide 34, ISO/IEC 17025 and certification
to ISO 9001:2008.
Cerilliant offers a wide variety of Snap-N-SpikeTM solutions for numerous clinical
applications including clinical chemistry, therapeutic drug monitoring assays, endocrinology,
clinical and diagnostic testing, or clinical toxicology. Our stable, quantitative
solution format provides significant benefits to the clinical laboratory including
increased efficiency of labor and materials and convenience of use. The Snap-N-SpikeTM
format allows laboratories to eliminate weighing operations of hazardous substances
such as immunosuppressants and provides the ability to spike into their matrix of
choice just before use. Clink on the links below to view these featured clinical
spiking solutions:
Cerilliant Certified Snap-N-SpikeTM Solutions of Immunosuppressants
Cerilliant Certified Snap-N-SpikeTM Solutions of Vitamins
Cerilliant Certified Snap-N-SpikeTM Solutions of Steroids and Hormones
Cerilliant Certified Snap-N-SpikeTM Solutions of Second Generation Anticonvulsants
Cerilliant Certified Snap-N-SpikeTM Solutions of Common Therapeutically Monitored Drugs
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