Change to the testing procedure for detection and quantification of BK virus (BKV) DNA in plasma, serum and urine samples.
This assay supports current recommendations for the prospective surveillance for BKV in the post-transplant setting. The current laboratory developed test (LDT) for BKV DNA will be replaced with a commercial assay targeting the large T antigen gene (Altona Diagnostics) in February 2015. The limit of quantification of the new assay is 1,000 copies/ml and the assay is linear from 1,000 –1,000,000,000 copies/ml. Validation at the NVRL showed good correlation at the clinical decision points of 5,000 and 10,000 copies/ml and provides accurate and precise quantitative measurements at these critical values. The Altona assay has a 100% PPV when compared to the LDT. Sample volumes of 0.5ml plasma, serum or urine are required to generate a result.
If you have any queries in relation to the above please don’t hesitate to contact the molecular laboratory on (01) 716 1240.