With the development of direct acting antivirals (DAAs) and the introduction of response

guided therapy patients are eligible for truncated therapy or treatment futility based on detectability of very low levels of HCV RNA at defined time points. As a result, accuracy in assessing HCV viral load at the low end buy Vemurafenib of the dynamic range for commercially available assays can have a tremendous impact on treatment decisions. However, there is a huge variability in plasma collection, storage and shipment to the laboratory. It is unknown to what extend different storage and transport conditions influence HCV RNA test results in samples with low level viremia. Methods: In order to mimic a low viremic setting we created plasma samples with targeted HCV RNA levels of 4-260 IU/ml by using human plasma and the WHO 2nd International HCV RNA standard. Aliquots of these samples were incubated at 4°C, 25°C (room temperature; RT) and 37°C for 2h, 6h, 12h, 24h, 72h, or up to 7d. In each aliquot HCV RNA was measured three times using the

Abbott RealTime HCV viral load assay. Results: HCV RNA was stable at 4°C, 25°C and 37°C even after 7 days of incubation. In samples with low but still quantifiable selleck chemical HCV RNA, HCV viral loads measured after 3-7 days of storage at 4°C and 25°C were nearly equal to baseline levels (mean decline: −0.06log and −0.11log, respectively) and showed only a small decrease if incubated at 37°C (−0.2log). For those samples with an HCV RNA level below the limit of quantification or detection, HCV RNA was detected

in 73% at baseline and in 67%, 58% and 79% of cases after storage at 4°C for 2-6h, 12-24h and 3-7d, respectively. In contrast, a small difference occurred after incubation at room temperature (58%, 67% and 58%) and at 37°C (50%, 56% and 67%). However, there was either exactly the same (25°C; RT) or even a higher (37°C) number of detected HCV RNA results after long incubation for 3-7d compared with only a short incubation period of 2-6h. Conclusions: MCE Storage of HCV RNA plasma samples at 4°C, RT or 37°C for up to 7 days does not have a significant impact on the reported HCV RNA result. Thus according to our data it seems unlikely that treatment decisions are influenced by plasma storage and transport conditions. We are currently investigating HCV RNA stability in serum and full blood as well as in samples obtained from patients receiving antiviral treatment. Data will be presented at the meeting. Disclosures: Benjamin Maasoumy – Advisory Committees or Review Panels: Abbott Molecular; Speaking and Teaching: MSD, Roche Diagnostics, Roche Pharma Gavin A. Cloherty – Employment: Abbott Molecular; Stock Shareholder: Abbott Laboratories Michael P.