ANTICORASE B-96 (TMB) (Anti-HBc total)
High-sensitivity qualitative ELISA for total antibody to HBV core antigen (Anti-HBc total) in serum/plasma. 100% sensitivity, 99.8% specificity, TFDA & CE approved.
PRODUCT DESCRIPTION
The GBC ANTICORASE B-96 (TMB) is a qualitative ELISA assay designed for the detection of total antibody against hepatitis B core antigen (Anti-HBc total) in human serum or plasma.
The assay employs the direct sandwich ELISA principle with antibodies immobilized in 96-well microplates and enzyme-conjugated components as the detection system. With a minimal sample volume of 50 µL and an incubation time of 90 minutes, the test provides rapid and reliable results.
Clinical validation in 5,812 hospitalized patients demonstrated 100% sensitivity and 99.8% specificity, with inter-assay CV < 15% and intra-assay CV < 20%. Results interpreted as Non-Reactive indicate no detectable Anti-HBc; Reactive samples confirm the presence of HBV core antigen antibodies and should be assessed in conjunction with clinical findings and other diagnostic markers.
Certified by TFDA and CE, the reagent is stable at 2–8°C and is well suited for both clinical diagnostics and epidemiological surveillance.
SPECIFICATION
✱Notified body: 0344
| Number of wells | 96 |
| Principle | Direct Sandwich |
| Assay format | Qualitative |
| Total incubation time | 90 minutes |
| Sample type | Serum / Plasma |
| Sample volume | 50 μL |
| Reading wavelength | 450nm |
| Storage | 2-8°C |
| Certification | TFDA / CE marked ✱ |
PERFORMANCE
5,812 hospitalized patients were tested. The diagnostic sensitivity is 100%；The diagnostic specificity is 99.8%
| Inter-assay precision CV | < 15% | Intra-assay precision CV | < 20% |
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ORDERING INFORMATION
| Catalogue No. | Product |
|---|---|
| 4CBE3 | ANTICORASE B-96 (TMB) |