Multicentric performance analysis of HCV quantification assays and its potential relevance for HCV treatment
| Autor: | Gudrun Naeth, Annemarie Berger, Patrick Braun, Heribert Knechten, Hans H. Hirsch, H. Wedemeyer, R. S. Ross, Stephan Regenass, Frank Wiesmann, Christoph Sarrazin |
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| Přispěvatelé: | University of Zurich, Wiesmann, F |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Microbiology (medical) Pathology medicine.medical_specialty Cobas taqman 030106 microbiology Single measurement Immunology Medizin 610 Medicine & health Hepacivirus Reference laboratory Antiviral Agents 2726 Microbiology (medical) 03 medical and health sciences medicine Humans Immunology and Allergy Viral load ddc:610 Reproducibility 2403 Immunology Plasma samples business.industry Reproducibility of Results COBAS Taqman General Medicine Hepatitis C Chronic Virology Patient management RealTime Assay variation HCV Hcv treatment 10033 Clinic for Immunology 2723 Immunology and Allergy RNA Viral Drug Monitoring business Rapid Communication |
| Zdroj: | Medical Microbiology and Immunology |
| Popis: | An accurate quantification of low viremic HCV RNA plasma samples has gained importance since the approval of direct acting antivirals and since only one single measurement predicts the necessity of a prolonged or shortened therapy. As reported previously, HCV quantification assays such as Abbott RealTime HCV and Roche COBAS AmpliPrep/COBAS TaqMan HCV version 2 (CTM v2) may vary in sensitivity and precision particularly in low-level viremia. Importantly, substantial variations were previously demonstrated between some of these assays compared to the Roche High Pure System/COBAS TaqMan assay (HPS) reference assay, which was used to establish the clinical decision points in clinical studies. In this study, the reproducibility of assay performances across several laboratories was assessed by analysing quantification results generated by six independent laboratories (3× RealTime, 3× CTM v2) in comparison with one HPS reference laboratory. The 4th WHO Standard was diluted to 100, 25 and 10 IU/ml, and aliquots were tested in triplicates in 5 independent runs by each assay in the different laboratories to assess assay precision and detection rates. In a second approach, 2 clinical samples (GT 1a & GT 1b) were diluted to 100 and 25 IU/ml and tested as described above. While the result range for WHO 100 IU/ml replicates across all laboratories was similar in this analysis, the CVs of each laboratory ranged from 19.3 to 25.6 % for RealTime laboratories and were lower than CVs of CTM v2 laboratories with a range of 26.1-47.3 %, respectively, and also in comparison with the CV of the HPS reference laboratory (34.9 %). At WHO standard dilution of 25 IU/ml, 24 replicates were quantified by RealTime compared to 8 replicates with CTM v2. Results of clinical samples again revealed a higher variation of CTM v2 results as compared to RealTime values. (CVs at 100 IU/ml: RealTime: 13.1-21.0 % and CTM v2: 15.0-32.3 %; CVs at 25 IU/ml: RealTime 17.6-34.9 % and CTM v2 28.2-54.9 %). These findings confirm the superior precision of RealTime versus CTM v2 at low-level viremia even across different laboratories including the new clinical decision point at 25 IU/ml. A highly precise monitoring of HCV viral load during therapy will remain crucial for patient management with regard to futility rules, therapy efficacy and SVR. CA extern |
| Databáze: | OpenAIRE |
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