Key words: PCR, guideline, standard
PCR is a molecular biology procedure that is used for the amplification and detection of nucleic acid sequences. It is used in biotechnology laboratories for various applications such as DNA sequencing and in clinical diagnostic laboratories for the in vitro diagnosis of infectious and genetic diseases. Commercial PCR-based medical device kit applications for the in vitro detection of infectious microorganisms are being submitted to FDA for evaluation. In order to gain a comprehensive understanding of PCR, an OST scientist has led the development of a PCR standard guideline with ASTM Committee E-48 on Biotechnology in collaboration with DIN (German Institute for Standardization). The ASTM guideline (Standard Guide for Detection of Nucleic Acid Sequences by the Polymerase Chain Reaction Technique) has recently been published. It consists of recommendations, basic considerations, criteria and principles that should be employed when developing, utilizing, or assessing PCR procedures and specific protocols for the amplification and detection of nucleic acid sequences. It was developed for use by PCR beginners and experts in any laboratory including clinical diagnostic laboratories.