Evaluation of the Artus HBV LightCycler kit for quantitative detection of hepatitis B virus in serum samples
Abstract number: 902_p1082
To evaluate the Artus HBV LightCycler kit for the quantitative detection of hepatitis B virus (HBV) in serum samples in comparison with the Roche COBAS system.
The Artus HBV LightCycler kit is designed to amplify a 290-bp sequence of the HBV genome. An internal control, included in the kit, was added to serum samples (n = 50) to monitor extraction as well as amplification inhibition. Quantitative data were compared with that generated by the Roche COBAS system.
Thirty-three (67%) samples were positive by both methods (one sample was insufficient for COBAS analysis). Two samples that were positive by COBAS but negative by Artus were both low copy number samples (2 × 102 and <2 × 102 copies/mL). One additional low copy number sample (3 × 102 copies/mL by COBAS assay) could not be quantified with the Artus kit. Amplification of the internal control was demonstrated for all of the negative samples. One-third of the positive samples (12/36) exceeded the dynamic range of the COBAS assay. Removing these samples from analysis, there was <1 log variation between the two assays for 16/24 (67%) of the comparable samples. Five samples were retested to assess intra-assay and batch-to-batch reproducibility. Variation for samples containing 103107 copies/mL was <0.5 log, whilst the low copy number sample (102 copies/mL) displayed <1 log variation over the three runs.
Overall, results obtained with the Artus kit on the LightCycler were in agreement with the COBAS data. Although the Artus kit appeared to be slightly less sensitive, a greater dynamic range was demonstrated."
|Session name:||XXIst ISTH Congress|
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