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Fundamentals of quality assessment of molecular amplification methods in clinical diagnostics. Clin Chem

By Michael Neumaier, Andreas Braun and Christoph Wagener For The International


The increasing interest in molecular biology diagnostics is a result of the tremendous gain of scientific knowl-edge in genetics, made possible especially since the introduction of amplification techniques. High expecta-tions have been placed on genetic testing, and the number of laboratories now using the relevant technol-ogy is rapidly increasing—resulting in an obvious need for standardization and definition of laboratory organi-zation. This communication is an effort towards that end. We address aspects that should be considered when structuring a new molecular diagnostic labora-tory, and we discuss individual preanalytical and ana-lytical procedures, from sampling to evaluation of assay results. In addition, different means of controlling con-tamination are discussed. Because the methodology is i

Year: 1998
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