The Roche Elecsys Anti-HBc II user manual provides assay principles, reagent handling, calibration, specimen requirements, and quality‑control procedures…
This manual describes the Elecsys Anti‑HBc II immunoassay, an electro‑chemiluminescence test for the qualitative detection of IgG and IgM antibodies to the hepatitis B core antigen in human serum and plasma. It outlines the intended use, test principle, and the competition‑based assay steps performed on cobas e and MODULAR ANALYTICS analyzers.
The document also details reagent composition, storage conditions, specimen collection, calibration procedures, quality‑control guidelines, result interpretation, and limits of detection and interference. Safety precautions and handling instructions for human material are included, along with performance data such as precision, specificity, and sensitivity.
| Assay duration | 27 minutes |
|---|---|
| Detection limit | ≤ 0.8 WHO IU/mL |
| Reagent storage temperature | 2‑8 °C (do not freeze) |
| Calibration frequency | Once per reagent lot |
The total assay duration is 27 minutes.
Store the kit upright at 2‑8 °C and do not freeze; unopened kits remain stable at this temperature until the expiration date.
The detection limit is ≤ 0.8 WHO IU/mL.