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European Biopharmaceutical Review

Incorporating Quality

With advances in automated technology and new clinical trials, and increasing cost, manpower and time pressures, quality assurance (QA) may seem like another complication in an already difficult puzzle. It is under precisely these conditions, however, that QA will provide increased reliability for the user in an environment with multiple variables.

QA of analytical systems is important to ensure the accuracy and precision of test results. Analysers are calibrated using serum-based samples to mimic the matrix of the patient or study participant and may only be required once every few days. However, to ensure accuracy of the detection on a daily basis, quality control serum is used to check the analyser is still calibrated accurately and the results are reliable. Of course, the number of times you are required to run controls depends on the reliability and quality of the analyser being tested. This will be determined through running a series of controls and establishing the correct interval to ensure reliable results.

The choice of supplier can have a massive influence on the ease of use and suitability of quality control (QC) sera for trials being undertaken. As with all essential pieces of laboratory equipment, decisions on the most appropriate sera and QA schemes should not be taken lightly.


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Dr Martin Crockard has been working at Randox since 2001 as team leader of a number of molecular biology projects developing predictive, diagnostic and prognostic assays for many human conditions. Project areas include breast and ovarian cancer, cardiac conditions and infectious diseases. Martin is also Senior Scientific Advisor within the marketing department. With a primary degree in Biological Science from the University of Ulster and PhD from Queen’s University Belfast, Martin studied gene expression changes involved in pathogenic and symbiotic interactions while working in the Northern Ireland Department of Agriculture. Email: marketing@randox.com
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Dr Martin Crockard
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