Active Standard ASTM E2048 | Developed by Subcommittee: E55.04
Book of Standards Volume: 14.02
Historical (view previous versions of standard)
Significance and Use
This guide is intended for use in any laboratory utilizing PCR or RT-PCR to amplify and detect nucleic acid sequences of mycobacteria from a biological preparation and to identify the species of origin.
The criteria used for the identification and evaluation of the amplification reactions should be administered by an individual trained in the use of molecular biological and microbiological techniques associated with PCR and MTB.
1.1 This guide covers basic considerations, criteria, principles and recommendations that should be helpful when developing, utilizing, or assessing PCR-specific protocols for the amplification and detection or identification of mycobacterial nucleic acids. This guide is not a specific protocol for the detection of specific mycobacteria. It is intended to provide information that will assist the user in obtaining high quality and reliable data. The guide is closely related to and should be used concurrently with the general PCR Guide E 1873.
1.2 This guide has been developed for use in any molecular biology or biotechnology laboratory. It may be useful for the detection of mycobacteria in clinical, diagnostic laboratories.
1.3 This guide does not cover details of the various methods such as gel electrophoresis that can be utilized to help identify PCR-amplified mycobacterial nucleic acid sequences, and it does not cover details of instrument calibration.
1.4 This guide does not cover specific variations of the basic PCR or RT-PCR technology (for example, quantitative PCR, multiplex PCR and in situ PCR), and it does not cover details of instrument calibration.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E1873 Guide for Detection of Nucleic Acid Sequences by the Polymerase Chain Reaction Technique
ICS Number Code 07.100.99 (Other standards related to microbiology)
UNSPSC Code 60104000(Biotechnology and bio chemistry and genetics and microbiology and related materials)