Quality Control and Quality Assurance

Molecular genetic tests are utilized widely. Nucleic acid amplification-based methods are sensitive and are prone to the contamination of amplification product. Besides, poor quality of the specimens, unskilled personnel, incorrect standard operation procedures (SOPs), and unqualified instruments may lead to false negative tests. Nucleic acid amplification-based assays are generally complex and need higher professional technical requirements. The interpretation of the results is crucial and should be done by qualified personnel. Thus, proper quality system is necessary for the timely and correct report. In this chapter, we talk about important components of quality system, highlighting the importance of establishing and following quality control and quality assurance. This text is intended to serve as a good laboratory practice primarily in amplification-based assays.