GB HDV Ab
Direct sandwich ELISA qualitative assay for HDV antibodies (IgG + IgM). 100% sensitivity, 98.6% specificity. 100 µL sample; TFDA certified; 105-minute incubation.
PRODUCT DESCRIPTION
This product is an in-vitro diagnostic qualitative ELISA kit for detection of antibodies to Hepatitis D Virus (HDV), including both IgG and IgM, in human serum or EDTA-plasma. It uses a direct sandwich ELISA format. Requires a 100 µL specimen, with total incubation time of 105 minutes, and reading at 450 nm. Clinical testing on 1,003 HDV Ab-positive specimens confirmed diagnostic sensitivity of 100% and specificity of 98.6%. Precision (CV) across runs, days, operators, sites, and lots is < 25%. Storage at 2-8°C. Non-Reactive indicates no detectable antibodies; Reactive indicates presence of HDV antibodies, to be interpreted with clinical correlation.
SPECIFICATION
| Number of wells | 96 |
| Principle | Direct Sandwich |
| Assay format | Qualitative |
| Total incubation time | 105 minutes |
| Sample type | Serum / Plasma |
| Sample volume | 100 μL |
| Reading wavelength | 450nm |
| Storage | 2-8°C |
| Certification | TFDA |
PERFORMANCE
1,003 HDV Ag seropositive specimens were tested. The diagnostic sensitivity is 100%；The diagnostic specificity is 98.6%
The precision results of ANTISURASE B-96 II (TMB) indicated a high level of precision with CV (%) < 25% within runs, between runs, days, sites, operators, and lots.
ORDERING INFORMATION
| Catalogue No. | Product |
|---|---|
| 4EHD001 | GB HDV Ab – 96T |