Development of working reference materials for clinical virology

Factors Contributing to Variability of Quantitative Viral PCR Results in Proficiency Testing Samples: a Multivariate Analysis

“…The consistent results seen for HIV and hepatitis viral load proficiency testing can be, at least in part, attributed to the fact that international quantitative standards have been broadly adopted for these targets (8,14,15); such international quantitative standards were not available for CMV, EBV, and BKV at the time of data collection for this study. The recent introduction of a WHO quantitative CMV standard can be expected to help address this issue, and standardization for EBV and BKV is planned (4,5). The impact of the detection reagent selected is also consistent with that in various reports in the literature.…”

Standardisation of nucleic acid amplification assays used in clinical diagnostics: A report of the first meeting of the SoGAT Clinical Diagnostics Working Group

“…Following the widespread implementation of NAT in clinical diagnosis and the requirement for accredited laboratories to have a procedure for external assessment, there are now a range of molecular EQA programmes available. The results from these and other studies have demonstrated variability in the performance of NAT assays for a number of clinical targets, [18][19][20][21][22] however, this may in part be due to a lack of standardisation. The variability in performance of assays for HPV, mycobacteria and HCMV was described by Dr James (HPA).…”

Comparison of microfluidic digital PCR and conventional quantitative PCR for measuring copy number variation

“…The measurable resolution of qPCR in our gene-amplification model for cfDNA, which we describe here as a ratio of 1.27, offers a theoretical diagnostic potential, however, the reality is that smaller CNVs, where the tumour contribution to the cfDNA can be as little as 5% of the total cfDNA (16,17) are still technically out of reach using qPCR. Furthermore, one of the major differences between qPCR and dPCR is that technical variability of qPCR can be high between and within laboratories (27). dPCR is notably less variable between experiments (28,29), which offers the possibility of reproducibly more accurate results.…”