GB HIV Ag-Ab COMB
High-sensitivity HIV antigen-antibody combo ELISA assay with 100% sensitivity and 99.9% specificity.
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PRODUCT DESCRIPTION
This product is based on the ELISA sandwich principle, utilizing highly specific antigen–antibody combinations to simultaneously detect HIV-1/2 antibodies and the HIV-1 p24 antigen. In the 96-well microplate, antibodies and antigens are immobilized as the solid phase, while purified peroxidase-conjugated components serve as the detection phase. This design minimizes cross-reactivity and reduces false positives, ensuring high sensitivity and reliability.
GB HIV Ag-Ab COMB assay is a manual 4th generation solid phase Enzyme-Linked Immunosorbent assay using a mixture of antigens and antibodies for the qualitative in vitro diagnostic screening in human serum or plasma (EDTA, Heparin, and Citrate) of antibodies to HIV-1 (group M and O), HIV-2 and HIV-1 p24 antigen. The device is for professional use only.
GB HIV Ag-Ab COMB assay is intended to be used as a screening test for donated blood to prevent transmission of HIV-1/HIV-2 to recipients of blood and blood components.
GB HIV Ag-Ab COMB assay is not intended to screen and diagnose acute or primary HIV infection.
GB HIV Ag-Ab COMB assay result does not distinguish between the detection of HIV-1 antibody, HIV-2 antibody, or HIV-1 p24 antigen and is not for diagnostic use.
PERFORMANCE
The diagnostic sensitivity is 100%；The diagnostic specificity is 99.9%.
| Precision | Variability | %CV |
|---|---|---|
| Repeatability | within run | <20% |
| Reproducibility | between-day | <20% |
| between-run | <20% | |
| between-sites | <20% | |
| between-operators | <20% | |
| between-lots | <20% |
SPECIFICATION
✱Notified body: 0344
| Number of wells | 96/480 |
| Principle | Sandwich |
| Assay format | Qualitative |
| Total incubation time | 150 minutes |
| Sample type | Serum / Plasma |
| Sample volume | 100 μL |
| Reading wavelength | 450 nm |
| Storage | 2-8°C |
| Certification | TFDA / CE marked ✱ |
ORDERING INFORMATION
| Catalogue No. | Product |
|---|---|
| 4EAIC11 | GB HIV Ag-Ab COMB – 96T |
| 4EAIC13 | GB HIV Ag-Ab COMB – 480T |