B-100 Hbsag Performance Improvement of Novel MASTM Infectious Controls for Serology Diagnostic Tests

Abstract Background Hepatitis B is a liver infection caused by the virus. While preventable vaccination, remains prevalent across globe. prevalence low in many areas of world, there are still regions which considered to be high. surface antigen (HBsAg) can one first indicators infection, and it commonly screened diagnostic test determine if patient immune, susceptible, or has acute chronic HBV infection. HBsAg critical marker diagnosing patient, presents unique challenges. The Thermo Scientific™ MAS™ Omni™ Infectious BSI Positive Control Panel* multi-constituent IVD control containing anti-HIV-1/2, anti-HBc, anti-HCV, anti-HTLV I/II antibodies, as well human plasma-based matrix. Development Stability Studies were conducted evaluate ensure optimal analyte performance throughout shelf-life duration. As this control, challenges must adequately addressed integrity reliability results all analytes. Two specific focus instability at increased temperature HBsAg-Fibrinogen interaction plasma products. We report here continued development assessment Omni Controls family. Methods Panel was evaluated with assays assess Shelf-Life demonstrate effect elevated fibrinogen on HBsAg. Shelf life products determined real-time, accelerated, open vial, in-use stability monitoring. Additionally, open-vial monitoring demonstrates relationship between within Between Month 0 12, samples run neat without processing. At centrifuged verify validity claim. Results evaluation effects Real-Time Accelerated studies combine temperatures multi-analyte control. Open-Vial completed 12 months Conclusions will perform optimally provided proper sample processing storage conditions implemented. Improper result degradation an rate for present sample. imperative that raw materials chosen production controls. When using products, best use defibrinated plasma. For extra precaution, material should filtered prior avoid due fibrinogen. Reliable, high-quality controls vital ensuring clinical functioning properly. *Availability product each country depends local regulatory marketing authorization status