Cytomegalovirus (CMV) is one of a number of human viruses that are ubiquitous in human populations, generally cause little illness upon infecting healthy individuals, but can cause life threatening disease in immune-compromised individuals. An important aspect in diagnosis and treatment is to track circulating viral load with molecular methods, particularly quantitative PCR. Standardization is vital due to inter-laboratory variability partly due to the variety of assays and calibrants. Towards that end NIST produced a standard reference material (SRM 2366) appropriate for establishing metrological traceability of assay calibrants. This standard is composed of CMV DNA (Towne 147 BAC DNA). Regions of the CMV DNA that are commonly used as targets for PCR assays were sequenced. Digital PCR was used to quantify the DNA with the concentration expressed as (genome) copies/microliter. The materials were tested for homogeneity and stability. An inter-laboratory study was conducted by Quality Control for Molecular Diagnostics (QCMD) where one component of the SRM was included for analysis by participants in a CMV external quality assessment program (EQA).
Citation: Journal of Molecular Diagnostics
Pub Type: Journals
Cytomegalovirus, Standard reference material, DNA Measurement standardization, digital PCR