In addition to its already broad offering of clinical and research based products for the in vitro diagnostics and life sciences industries, Binding Site now offers human clinical specimens to both IVD manufacturers and suppliers. The availability and sourcing of high quality clinical specimens is vital in ensuring the scientific relevance and validity of clinical instrumentation and reagent applications. In addition, these specimens are also necessary for a host of other critical studies, including new product development work, validation studies and ongoing technical support projects. Compliant with all regulatory and quality standards guidelines, the clinical specimens can be provided in a variety of different matrices, which can be further characterised by specific analyte and concentration/titre, along with additional information on age, gender and disease state. Specimen volumes are available in a variety of configurations ranging from millilitres up to litre volumes, and are offered in a variety of formats (i.e. pooled sera/plasma, single donor, dialysed serum, etc.). All necessary documentation and paperwork is supplied with each shipment.
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Ureaplasma are very small free-living bacteria that, like the Mycoplasmas, have no cell walls. Named for their metabolic utilisation of urea, the bacteria possess a small simple genome. Ureaplasma parvum is the species found in the human urogenital tract. Its presence has been associated with several conditions including urethritis, pelvic inflammatory disease, congenital pneumonia and neonatal meningitis. ViroStat has introduced a set of new monoclonal antibodies to U. parvum for applications in ELISA and IFA.
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Lupus anticoagulant is the most common cause of acquired thrombophilia. The incidence of lupus anticoagulant in the general population is 1% to 2%. Chronic lupus anticoagulant is associated with a 30% risk of venous thromboembolic disease or arterial thrombosis, including stroke and myocardial infarction, as well as with chronic spontaneous abortion. For use in the platelet neutralisation procedure (PNP), Lupus Anticoagulant Confirmation Reagent (LA-CR) is used to determine if the prolongation of an activated partial thromboplastin time (APTT) is due to the presence of lupus anticoagulant. The reagent is a lyophilised preparation of phosphatidyl enhanced platelet phospholipid, the addition of which will shorten the APTT time in the presence of the lupus anticoagulant. Thus, the platelet neutralisation procedure is a valuable diagnostic test to confirm lupus anticoagulant.
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A new HPV genotype qualification panel expands the Sera- Care Women’s Health portfolio in response to the rapidly rising demand for products designed to meet the requirements for HPV assay qualification. The panel is derived from cultured human cells containing fulllength HPV DNA and includes the HPV 16 and HPV 18 genomes, which together account for an estimated 70 percent of all cases of the virus. The panel is designed to support assay qualification and testing by challenging every step in the process, from extraction through detection. The panel is designed for use with HPV test kits from Roche Molecular Diagnostics, Qiagen/digene and Hologic. In addition to supporting the vital process of assay verification, the panel can also be used for method comparison, reproducibility and lot-to-lot variability studies.
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A new middleware for clinical chemistry, microbiology and molecular biology labs is available. Utilising a rule-based engine to deliver all-round control over laboratory workflow and sample processing, HALIA’s powerful functionality significantly improves laboratory efficiency, compliance and quality control. The middleware interface provides a complete web-based lab computerisation system, allowing central management and connection of all analysers through a single interface on any workstation. The user-configurable rule-based engine enables autoverification, sample routing and real-time clinical data capture and management for greater quality control. By supporting open automation systems and addressing issues such as regulatory compliance, workforce reductions and enhanced quality control, this middleware effectively meets the challenges facing lab managers. Responding to the increase in Point of Care Testing, a POCT Data Manager function is offered. This gives lab managers a real-time overview of all the data relating to multiple blood gas analysers or other devices, including instrument maintenance schedules and QC alerts. Detailed real-time data on total turnaround time (TAT) – a key performance indicator in large laboratories striving to increase throughput – is also provided. If a LIS/LIMS system goes down, the backup module allows manual input of sample information. Manual samples are then matched to LIS/LIMS data once the connection is restored.
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