B-099 Development and Improvement of Novel MASTM Infectious Controls for Serology Diagnostic Tests

Abstract

Abstract Background Human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) remain major infections around the world. As not all viral infections are preventable, serological assays play a critical role in diagnoses, therapeutic monitoring, and treatment of these infections. The Thermo Scientific™ MAS™ Omni™ Infectious Controls are a family of controls containing single or multiple analytes in human plasma-based matrix designed to mimic patient samples in the assessment of serological assay performance. One of the greatest challenges within the field of Infectious Serology testing is method variation amongst the semi-quantitative assays. As an example, a result that is considered a low positive on one analyzer, may be considered a high positive on a different analyzer. Therefore, platform agnostic Quality Control material will provide evaluation among different methods. Quality Controls may also be developed to focus on certain platforms based on “fit-for-purpose” applications. We report here the development and performance evaluation of the MAS™ Omni Infectious Controls - For Use with Siemens Assays. Methods Two new MAS™ Omni Infectious Controls were developed and characterized to be added to the existing catalog of MAS™ Omni Infectious Control Products. MAS™ Omni Infectious BSI (Bloodstream Infectious) Positive Control Panel—For Use with Siemens Assays* is a multi-constituent IVD quality control containing anti-HIV-1/2, anti-HBc, anti-HCV, and anti-HTLV I/II antibodies, as well as Hepatitis B surface antigen (HBsAg) that was developed for the Siemens Assays platform. The new product has been adapted from the existing BSI Positive Control Panel* by increasing the titer of HBsAg while decreasing the titer of anti-HBc and anti-HCV. MAS™ anti-HBs Positive Control - For Use with Siemens Assays* was developed for the assessment of assay performance detecting anti-HBs on the Siemens Assays Platform. The new product has been adapted from the existing anti-HBs Positive Control by increasing the titer of anti-HBs. Development and performance evaluations were performed on SIEMENS™ and non- SIEMENS™ platforms. Shelf life of the products are determined by accelerated, real-time stability, open vial, and in-use monitoring. Results Two new MAS™ Omni Infectious Controls were developed and evaluated to be specifically used on the Siemens Assays Platform. Both products demonstrated acceptable performance on the SIEMENS™ Centaur™ and Abbott™ Architect™. Stability studies demonstrated a minimum of 24- or 12-months shelf life, 30 or 60 days of open vial stability, and 8 hours of in-use stability when stored at 2–8°C, respectively. Additionally, the studies demonstrate a basic understanding of method variation within Infectious Serology test methods. Conclusions Two new MAS™ Omni Infectious Control products that mimic patient samples have been developed for the assessment of assay performance on the Siemens Assay Platform in the clinical laboratory for anti-HBc, anti-HCV, and Hepatitis B surface antigen (HBsAg). These reliable and stable control materials will better support the assessment of serological assay performance on the Siemens platforms. *Availability of product in each country depends on local regulatory marketing authorization status