Bio-Rad Laboratories has recently announced the launch of its Exact Diagnostics HBV, HCV and HIV-1 Run Controls in Europe, offering European labs a new line of external quality controls for monitoring the performance of molecular virology assays. The controls are calibrated against the 3rd WHO International Standard for HBV (10/264), the 4th WHO International Standard for HCV (06/102) and the 3rd WHO International Standard for HIV-1 (10/152), respectively. Each of these controls is calibrated using digital droplet PCR.
The Exact Diagnostics virology controls are intended for testing the entire process of various assays including extraction, amplification and detection. The products consist of whole viruses in a true EDTA plasma matrix in order to simulate clinical patient specimens, and have a 36-month shelf life when stored at -20°C as well as a 24-hour stability when stored at 2-8°C.
Ordering options include verification panels with wide dynamic ranges to establish qualitative and quantitative points of reference for the measurement of viral DNA or RNA (7 1.0 mL vials), high and low run controls (5 1.0 mL vials each), and larger verification panel bundles. The HBV, HCV and HIV-1 controls allow labs to evaluate day-to-day and lot-to-lot variation in their molecular assays as well as test for factors like operator proficiency.