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This evaluation demonstrates the sensitivity and accuracy of a PCR-based assay for JC polyomavirus detection in urine and plasma samples.
We evaluated the performance of the automated AltoStar JCV PCR platform for detecting and quantifying JC Polyomavirus (JCPyV) DNA in samples including urine, plasma and cerebrospinal fluid. Using the NIBSC JCPyV DNA standard, the assay was linear from 1 to 6 log IU/mL standard and the limit of detection determined by Probit analysis corresponded to 9.3 [95 % CI: 7.0-16.5] IU/mL. Specificity was accessed by testing urines containing a high concentration of BK Polyomavirus; none tested positive for JCPyV. The intra-run and inter-run standard deviations were 0.02 IU/mL and 0.35 IU/mL, respectively. Lastly, clinical performance was determined by testing 45 samples quantified previously with a laboratory-developed test (LDT). The assays were concordant for 42/45 samples. One of the 3 samples that tested negative with the AltoStar assay had a low JCpyV DNA concentration. We were unable to re-test the 3 negative samples due to insufficient volume. A conservation problem could not be ruled out for the 3 samples with discordant results. The AltoStar platform enables highly accurate testing for the detection and quantification of JCPyV DNA with very low limit of detection. This allowed us to shorten turnaround times and save time for technical staff.
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Lhomme et al. (2025) studied this question.
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