Spotlight Clinical, Medical & Diagnostic Products Accelerating Sample Preparation


Porvair Sciences Ltd has produced an application note that describes a method for the rapid and sensitive determination of a novel drug entity in human plasma.


Key to the high throughput of this method is the use of the Microlute™ 96-well SPE system, which allows a batch of samples to be prepared for injection in less than half the time that is actually required to analyse them. The method meets all regulatory requirements for clinical studies, and is suitable for the analysis of large numbers of samples. A copy of Application Note D may be downloaded from the Porvair website.


The developed method using the Microlute™ was validated over a concentration range of 100 to 10,000 pg/ml. Recovery using the SPE method was approximately 60%, and consistent across the calibration range. The authors describe how the Microlute™ SPE method, unlike protein precipitation sample preparation, is free from LC/MS matrix effects that may influence the ionisation of the compound(s) of interest.


Developed in conjunction with a leading pharmaceutical company the Microlute™ has become the benchmark for high throughput sample preparation across a range of applications. The innovative design of the Microlute™ from Porvair Sciences Ltd offers all the advantages of automated and high throughput SPE sample preparation in a convenient microplate format capable of rapidly processing 96 samples in one go repeatedly and precisely.


Circle no. 592


More than 250 UK and Irish laboratory managers recently met in London to participate in Siemens Healthcare Diagnostics’ first annual Siemens Academy meeting. The three-day event provided an engaging and enlightening forum to learn commercial skills, understand the need for long-term pathology planning, embrace business tools and absorb scientific best practice from peers spearheading change.


New Portfolio of Surfaces for Cell based Drug Discovery Screening


BD Biosciences has announced the launch of its new line of BD PureCoat™ cell culture surfaces designed to help life science researchers in the pharmaceutical and biotechnology industries, as well as the academic research community, improve cell performance and assay reproducibility.


“Today’s life science researchers are increasingly using primary cells, transfected cells and stem cells in research and drug discovery assays. These fastidious cells often require optimised cell culture surfaces to achieve reproducible and consistent assay results,” said Carolyn James, Country Business Leader UK and Ireland, BD Biosciences. “BD Biosciences is committed to providing researchers with advanced surfaces that enable them to utilise these cells in a highly defined and controlled cell culture environment.”


In basic cell culture research, scientists are looking for methods to improve cell growth and reduce or remove the serum in culture media to save costs and reduce variability. BD PureCoat surfaces improve cell attachment, increase


proliferation and enhance


recovery from freeze- thaw for a variety of primary, transfected and transformed cells in serum -reduced or serum -free culture conditions. This allows researchers to produce more cells in better defined conditions.


In cell -based drug discovery screening, scientists often culture transfected and cryopreserved division arrested cells for use in cell - based screening assays. Strong attachment of these cells is critical to achieving a robust assay, and cell monolayer consistency is directly related to reproducible assay results. BD PureCoat surfaces maintain the integrity of the cell monolayer, offering superior consistency in cell -based assays versus standard tissue culture surfaces. The new BD PureCoat amine and carboxyl surfaces utilise a proprietary thin film coating technology to produce a uniform, functionalised surface for cell culture.


Circle no. 593


Specialist lectures, real laboratory case studies and open debate sessions were combined to draw together all the key topics facing pathology. Guest speakers, Siemens representatives and the hundreds of delegates were able to discuss openly the current challenges and solutions facing pathology today.


Topics discussed included the commercialisation of pathology; the impact of both the Carter and Darzi reports; the strategies needed to address an ageing scientific workforce; advances in point of care testing and laboratory automation; plus effective business management and leadership skills to move pathology forward. Customer speakers included University Hospitals Bristol NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Norfolk and Norwich University NHS Trust, King’s College Hospital NHS Foundation Trust, NHS Grampian and Partnership Pathology Services.


Delegates were also introduced to NHS Pathology Plus, a Siemens led partnership programme that helps leading NHS Trusts to respond effectively in the evolving diagnostics marketplace. The partnerships provide Siemens customers with the commercial support needed to extend their reach into primary care, and to other secondary care partners


The next annual Siemens Academy event is scheduled for June 2010.


Circle no. 594


Taking Diagnostics to the Next Level


Three Tests for a Confident Diagnosis


Widely known as the ‘kissing disease’, infectious mononucleosis is mainly caused by Epstein-Barr virus (EBV). To confirm an EBV infection, serological tests are used to interpret the profile of the most relevant immunological responses: viral capside antigens (VCA) IgG and IgM, early antigens (EA IgG) and Epstein- Barr nuclear antigens (EBNA) IgG.


The VIDAS® EBV offer is comprised of three tests designed to provide the most


relevant EBV antibody responses when used in combination for stage-specific diagnosis of EBV infection. The innovative combination of EA and VCA P18 detection in the VIDAS EBV VCA/EA IgG test improves the global positive response of the kit when used to confirm primary stage EBV infection, as EA IgG appear at the early stage of infection in 80% of infectious mononucleosis cases. The same test protocol is used for all three tests, and results are provided in 40 minutes.


bioMérieux has registered three peptide sequence patents to develop these tests (EA P54, VCA P18, EBNA P72).


Circle no. 595


Methods for the Diagnosis of Heart Failure Reviewed


A blood test (BNP) should be recommended over an electrocardiogram (ECG) for the diagnosis of heart failure, suggests research published by the National Institute for Health Research Health Technology Assessment (NIHR HTA) programme.


Heart failure is associated with significant morbidity, mortality, and healthcare expenditure. There is however, a good evidence base for interventions to improve prognosis although the diagnosis of heart failure in primary care is often inaccurate. Current NICE recommendations are that patients in whom heart failure is suspected should undergo ECG and/or BNP. If either of these is positive, they should then be referred for echocardiography as part of their diagnostic work-up.


The study led by Professor Jonathan Mant, University of Cambridge, reviewed existing evidence to determine the best way for primary care physicians to diagnose heart failure in the UK. From their findings the research team have developed a simple clinical rule: patients who present with symptoms such as breathlessness and in whom heart failure is suspected should be referred directly to echocardiography if they have: a history of MI, basal crepitations, or are male and have ankle oedema. Otherwise a BNP test should be conducted initially, and depending on these results, then referred for echocardiography.


“From our research we have been able to develop a decision rule that is likely to be cost-effective to the NHS,” said Professor Mant. “Our economic analysis further suggested that if improvement in life expectancy was taken into account, then the optimum strategy would be to refer all patients with symptoms suggestive of heart failure directly for echocardiography.”


Professor Mant added: “We hope that our analysis will help inform a review of the current NICE recommendation.” Circle no. 596


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