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Abstract
Diagnostic reagents of polymerase chain reaction (PCR) nucleic acid amplification is growing more and more important in the field of clinical diagnosis along with the development of the PCR technology. During to the complexity of the detection target and the clinical requirements for measuring linearity, accuracy, specificity, subtype detection, precision, limit of detection/quantification and interfering substance, the diagnostic reagents of nucleic acid amplification have a very strict control system. In order to ensure the quality of the experimental data of quantitative PCR, there have been standards such as The Minimum Information for Publication of Quantitative Real–Time PCR Experiments (MIQE), aiming to putting forward specific requirements for sample processing, experimental designing, system setting and quality control. But in the clinical application of nucleic acid amplification products, lots of requirements are not clear for the PCR system setup. This article discussed the requirements of PCR system setting, quality control system and Methodology of nucleic acid extraction and purification, aiming to promote the related design and the establishment of the standards of relevant.(Chin J Lab Med, 2015, 38: 709–712) Key words: Polymerase chain reaction; Reagent kits, diagnostic; Quality control
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