Method Development

HRL has close ties in collaborative research with internationally recognized investigators based at the Henderson Research Centre whose research activities  focus on clinically relevant problems of vascular disease; including heart attacks, stroke and other cardiovascular disorders, and thrombosis of limb vessels.

HRL is committed to a better understanding of hemostasis and thrombosis. Dealing with a growing demand for specialized hemostasis laboratory testing, HRL is finding ways to respond effectively to the needs of all our clients by closely monitoring the evolution of testing and the need and availability of new assays. Our dedicated team of laboratory personnel is involved in improvement and development of state-of-the-art testing procedures as well as the improvement of all laboratory processes.

Quality Factor

HRL’s quality process provides our clients with customized services while remaining focused on the “Quality Factor”.  Method Development and Method Validation are an important process in establishing confidence that an assay is reliable as well as the extent of that reliability.

Method Development and Validation is performed according to NCCLS recommendation. When required, method validation is performed according to documents from the workshop on "Bioanalytical Methods Validation for Macromolecules" by Miller et al (2001) and the "Guidance for Industry" on Bioanalytical Method Validation produced by the FDA in May 2001.

Validation parameters such as selectivity (“baseline”), matrix effect, linearity, imprecision, reproducibility, accuracy, upper and lower limit of quantification, sample stability and recovery are investigated. Normal references intervals are determined for all assays where applicable. The validated results obtained by HRL are compared to those available from the manufacturer and from peer-reviewed publications. In this way, a more complete picture of the assay characteristics emerges. The quality assurance provides a joint improvement opportunity for both HRL and its clients.