Large-Scale Clinical Validation of Sekbio HIV 1/2 Antigens Across 1,717 Specimens vs. EIA Reference
A comprehensive clinical performance evaluation of Sekbio HIV 1/2 antigens was conducted using 1,717 characterized specimens confirmed by EIA — one of the largest independent HIV antigen validation datasets in our portfolio.
| Result Category | EIA Positive (n=555) | EIA Negative (n=1,162) |
|---|---|---|
| Rapid Test Positive | 554 | 4 |
| Rapid Test Negative | 0 | 1,159 |
| Positive agreement: 554/(554+0) >99.9% | Negative agreement: 1,159/(1,159+4) = 99.6% | Total agreement: 1,713/1,717 = 99.8% | ||
Analytes spiked into negative plasma/serum pools and low-positive specimens at clinically relevant concentrations. Tested in triplicate with 3 lots. Visual interpretations at 15 and 20 minutes.
| Interfering Substance | Result at 15 min | Result at 20 min | Conclusion |
|---|---|---|---|
| Bilirubin (high concentration) | No interference | No interference | ✓ Pass |
| Hemoglobin (hemolysis) | No interference | No interference | ✓ Pass |
| Lipids (triglycerides) | No interference | No interference | ✓ Pass |
| Rheumatoid Factor | No interference | No interference | ✓ Pass |
| All tested substances | No differences observed between 15 min and 20 min | ✓ No interference | |
Cross-reactivity panel of specimens confirmed positive for potentially interfering conditions, tested with HIV 1/2 Rapid Test Device at 15 and 20 minutes.
| Potentially Cross-Reacting Condition | HIV Result at 20 min |
|---|---|
| HCG positive (pregnancy) | Negative ✓ |
| HCV antibody positive | Negative ✓ |
| Syphilis positive | Negative ✓ |
| HBsAg positive | Negative ✓ |
| Heterophilic antibodies | Negative ✓ |
| HAMA positive | Negative ✓ |
| RF factor positive | Negative ✓ |
| No cross-reaction observed with any tested condition. No difference between 15-minute and 20-minute readings. | |
10 sets of BBI positive control sera tested on the chemiluminescent immunoassay (CLIA) platform. Evaluation conducted against Abbott ARCHITECT i2000 reagents across 60 serum samples.
| Parameter | Result |
|---|---|
| BBI Positive Control Sets | 10 sets tested |
| Reference System | Abbott ARCHITECT i2000 |
| Clinical Specimens | 60 serum samples |
| Concordance with Abbott i2000 | Strong positive agreement confirmed |
Recombinant HIV 1 and HIV 2 antigens for lateral flow rapid test development — validated clinical performance with >99.9% positive agreement and 99.6% negative agreement vs EIA reference.
HIV antigens validated on CLIA platform vs Abbott i2000. Suitable for integration into chemiluminescence analyzer reagent systems for high-throughput HIV screening.
The 1,717-specimen validation scale demonstrates readiness for deployment in national HIV screening programs, blood bank screening, and STI clinic testing in high-prevalence regions.
HIV 1/2 recombinant antigens available as OEM raw material for rapid test and CLIA kit manufacturers. Full clinical validation documentation available for regulatory submissions.
Technical datasheets, performance data, and OEM pricing available on request.