The new NIST reference, SRM 2366, addresses the variability problem by providing a standardized CMV DNA. Consistency of the viral DNA in the standard was ensured by manufacturing it in Escherichia coli bacteria. These E. coli cells each contain a copy of the CMV genome in a "DNA construct"an artificially constructed segment of nucleic acid that codes for a specific product, in this case, CMV DNA. The DNA copies made by this E. coli cell culture "factory" can then be purified and quantified using digital PCR
SRM 2366 consists of three solutions, each with a specific concentration of CMV DNA copies per microliter: 420, 1,702 and 19,641. These are designed to qualify prepared calibration samples (known as calibrants). They also can be used as quality control samples for diagnostic equipment. For added traceability, the SRM certificate of analysis includes the genetic sequences of the nine CMV genome regions copied for the standard.
SRM 2366 joins more than 50 reference materials produced by NIST for quality control in clinical testing. Standard Reference Materials are among the most widely distributed and used products from NIST. The agency prepares, analyzes and distributes about 1,300 different materials that are used throughout the world to check the accuracy of instruments, validate test procedures and serve as the basis for quality control standards worldwide.
|Contact: Michael E. Newman|
National Institute of Standards and Technology (NIST)