Applying validated control materials of hepatitis B surface antigen to assess the sensitivity of enzyme-linked immunosorbent assays in chemiluminescence immunoassays

BACKGROUND: The use of externally validated reference materials ensures quality control in laboratory research. The use of domestically produced control materials traceable to international standards and registered as independent medical devices is significant. Currently, enzyme-linked immunosorbent assays and chemiluminescence immunoassays are frequently employed to detect hepatitis B surface antigen (HBsAg), the main marker of the relevant infectious disease. Standard control samples meeting the above requirements are available for sensitivity assessment of enzyme-linked immunosorbent assay test systems, whereas there are no such quality control materials for chemiluminescence immunoassays.

AIM: Тo demonstrate whether certified control materials for in-laboratory quality control of the measurement of HBsAg by the enzyme-linked immunosorbent assay method can be used for studying analytical sensitivity of chemiluminescence immunoassays.

MATERIALS AND METHODS: Domestic standard samples “DS-SO-HBsAg” (RPC Diagnostic Systems, Russia) and “HBsAg — standard serum panel” (Vector-Best, Russia) were used for testing the sensitivity of two registered foreign-made medical devices for chemiluminescence immunoassays: kit for evaluating the hepatitis B surface antigen (HBsAg CLIA kit) in a human clinical sample by immunochemiluminescent method on analyzers of the CL series (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., China) and in vitro diagnostic reagents for the qualitative detection of the surface antigen of the hepatitis B virus (HBsAg) using the “ARCHITECT I” analyzer (ARCHITECT HBsAg Qualitative II Reagent, Abbott, Ireland).

RESULTS: The chemiluminescence immunoassay kits interacted accurately with the control materials used within the limits of the characteristics stated in the operational documentation.

CONCLUSION: The results indicate that validation of the use of reference materials for quality control of test systems, which are based on fundamentally similar but not identical methods of analysis, contributes to improving the quality control system for clinical laboratory diagnostics by expanding the scope of use of registered control materials.