SURASE B-96 (TMB) (HBsAg)
A high-sensitivity, high-specificity ELISA reagent for qualitative detection of Hepatitis B surface antigen (HBsAg) in serum/plasma; low false positives ensured.
PRODUCT DESCRIPTION
This product utilizes highly specific and high-affinity murine monoclonal antibodies immobilized on a 96-well microplate as the solid phase, and affinity-purified rat antibodies conjugated with peroxidase as the liquid phase. By employing heterologous antibodies in both phases, the assay significantly reduces cross-reactivity and minimizes false positives, ensuring superior performance and reliability.
The reagent is intended for the qualitative detection of Hepatitis B surface antigen (HBsAg) in human serum or plasma, based on the ELISA sandwich principle. Samples yielding Non-Reactive results can be considered free of detectable HBsAg. Samples yielding Reactive results should be retested and confirmed with a neutralization assay; only confirmed reactive samples can be interpreted as containing HBsAg or Hepatitis B virus (HBV).
SPECIFICATION
✱Notified body: 0344
| Number of wells | 96/480 |
| Principle | Sandwich |
| Assay format | Qualitative |
| Total incubation time | 110 minutes |
| Sample type | Serum / Plasma |
| Sample volume | 50 μL |
| Reading wavelength | 450 nm |
| Storage | 2-8°C |
| Certification | TFDA / CE marked ✱ |
PERFORMANCE
The diagnostic sensitivity is 100%；The diagnostic specificity is 99.58%
| Precision | Variability | %CV |
|---|---|---|
| Repeatability | within run | <20% |
| Reproducibility | between-day | <20% |
| between-run | <15% | |
| between-sites/between-operators | <20% | |
| between-lots | <15% |
ORDERING INFORMATION
| Catalogue No. | Product |
|---|---|
| 4SGE3 | SURASE B-96 (TMB) – 96T |
| 4SGE11 | SURASE B-96 (TMB) – 480T |