In this study, researchers performed a multicenter evaluation of a new assay, for the detection of hepatitis C virus (HCV) RNA in human serum or plasma. The assay is based on transcription-mediated amplification (HCV TMA).
The research team's findings are published in the February issue of the Journal of Clinical Microbiology.
The team combined data from 15 independent sites, including 4 sites in the United States and 11 in Europe.
They found that the pre-production assay kits showed a limit of detection of 9.8 IU/ml, as well as an overall mean specificity of 98%.
|Pre-production assay showed an overall mean specificity of 98%.|
|Journal of Clinical Microbiology|
In addition, they determined that assay runs and samples were valid consistently (98% of assay runs and 98% of specimen results).
Of the 15 participating sites, 2 carried out additional performance studies using production kits, in support of the assay's registration in France.
When the team compared the findings from these 2 sites they found an overall improvement in assay performance.
This improvement was statistically significant for both specificity and specimen validity, 99% and 98%, respectively.
Furthermore, combined data from the 2 sites showed a lower limit of detection, of approximately 2.4 IU/ml, and an improved assay validity of 100%, although the sample size was too small for this to be statistically significant.
Dr David Hendricks's team concluded, "The performance characteristics of HCV TMA indicate that this assay is a reliable tool for the detection of HCV RNA in serum or plasma".
"Improvement in assay performance has been demonstrated with refinement of assay reagents, instrumentation, and operator experience".