Common use of Laboratory Assessments Clause in Contracts

Laboratory Assessments. At each study visit, all subjects had venous blood samples collected by a clinical scientist (SE) following a 10 hour overnight fast. Thirty millilitres of whole blood was collected in serum separation tubes (SST’s) for measurement of lipid and bone profiles. The prospective study group had also had routine haematology and clinical chemistry tests performed at screening to exclude any secondary causes of OP. These included a full blood count (FBC), erythrocyte sedimentation rate (ESR), protein electrophoresis, parathyroid hormone (PTH), vitamin D and a full lipid, bone, renal and thyroid profile. Six millilitres of whole blood was sent to St ▇▇▇▇▇▇ Hospital Department of Clinical Chemistry for the measurement of total cholesterol, triglycerides, HDL and LDL-cholesterol levels in addition to calcium, albumin corrected calcium, albumin, phosphate and sodium, magnesium and chloride using standard laboratory methods on the Roche Modular analysers (Roche Diagnostics Limited, West Sussex, UK). The remaining 24mls of whole blood was centrifuged and serum was separated into 10 aliquots which were then frozen at -70o for the analysis of systemic and local factors involved in bone remodelling and atherosclerosis. These included PTH, PINP, CTX, vitamin D, sclerostin and Dkk1. Parathyroid hormone and vitamin D was analysed by consultant chemical pathologist ▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ in the Department of Clinical Chemistry at St ▇▇▇▇▇▇’ Hospital. PINP, CTX, sclerostin and Dkk1 were analysed by the commercial bone marker laboratory at the University of Sheffield. During the prospective study a further blood sample was collected at 6, 12 and 24-months for the measurement of circulating endothelial progenitor cells (EPCs). These samples were processed immediately after collection and analysed using flow-cytometry to enable identification and characterisation of EPCs. Analysis was performed by ▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇ in the flow-cytometry department of the Clinical Trials Unit at Guy’s Hospital.