Cobas ampliprep cobas taqman hcv quantitative test version 2

At each visit, patients were assessed by a study doctor. AEs and ARs were recorded and graded according to a standardised scale (National Institute of Health, 2017 ) and medication adherence and use of healthcare facilities were recorded on case report forms.
HCV RNA was measured in the hospital using the available commercial platform. At start of study (for the first 41 participants enrolled), this was the Abbott Architect (LLOQ=12 IU/ml). This was subsequently replaced with the COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, version 2.0 (Roche Molecular Systems, LLOQ=15 IU/ml). Standard laboratory tests—including full blood count, renal function and liver function tests—were performed in the hospital laboratory at baseline, EOT and EOT+12.

The HCV-RNA levels were measured with the COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, version 2.0 (Roche; lower limit of quantitation = 15 IU/mL) at baseline as well as after 2, 4, 8, 12, 16 and 24 weeks for patients treated until the 24th week (W2, W4, W8, W12, W16, W24) during treatment. Follow-up measurements were collected at 4 and 12 weeks post-treatment. HCV-RNA was positive if the level was >15 IU/mL, whereas detectable but not measurable HCV-RNA levels were reported as <15 IU/mL and scored as a gray zone. Only samples with an undetectable level of HCV-RNA were considered negative. The HCV genotype and subtype were determined using the Siemens VERSANT HCV Genotype INNO-LiPA 2.0 Assay.
HCV-Ag was retrospectively measured in serum samples obtained at the same time points as the HCV-RNA using an automated chemiluminescent HCV-Ag assay (Abbott Diagnostics, Wiesbaden, Germany) that was performed on the Abbott ARCHITEC T i2000SR platform according to the manufacturer’s instructions. The cut-off value for HCV-Ag detection was 3.0 fmol/L. Levels below 3.0 fmol/L were considered non-reactive, levels between 3 and 10 fmol/L represented the “gray” zone, and levels above 10 fmol/L were positive for HCV-Ag. The dynamic range of the test was 3–20,000 fmol/L, and an automated dilution extended this range to 180,000 fmol/L.