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Specifications:
| Application | Diagnostic Testing |
| Storage Temperature | Room Temperature |
| Product Type | Test Kit |
| Product Brand | CTK Biotech |
| Product Grade | Medical grade |
The OnSite HIV Ag/Ab 4th Generation Rapid Test is an advanced point-of-care (POC) lateral flow immunoassay designed for the qualitative detection of HIV-1 p24 antigen and antibodies (IgG, IgM, IgA) to HIV-1 (including Group O) and HIV-2 in human serum, plasma, or whole blood. This fourth-generation HIV test enables earlier detection of HIV infection during the acute phase, bridging the diagnostic window between infection and antibody development.
Ideal for clinical, community-based, and field settings, the test offers accurate and rapid results in 15 minutes, supporting early diagnosis, counseling, and immediate linkage to care.
Key Features and Benefits
- 4th Generation Dual Detection: Detects both HIV-1 p24 antigen and HIV-1/2 antibodies for early-stage and established infections
- Minimal Sample Volume: Requires only 5 µL of specimen
- Flexible Specimen Compatibility: Use serum, plasma, or whole blood
- Rapid Results: Delivers results in approximately 15 minutes
- Validated Performance: Tested with BBI low titre panel and Chinese FDA HIV Ab panel
- Convenient for POC Testing: Enables timely diagnosis and clinical decision-making
- Compact Kit Contents: Individually sealed components with desiccant for test stability
Kit Contents (Per Box of 30 Tests)
- 30 test cassettes (individually sealed foil pouches)
- 30 capillary tubes (20 μL)
- Sample diluent (5 mL, REF SB-R0018)
- Desiccants
- Instruction leaflet (IFU / package insert)
Product Specifications
| Attribute | Details |
|---|---|
| Detection Targets | HIV-1 p24 Antigen, HIV-1/2 Antibodies (IgG, IgM, IgA) |
| Format | Lateral Flow (Cassette) |
| Test Time | ~15 minutes |
| Sample Volume | 5 µL |
| Specimen Types | Serum, Plasma, Whole Blood |
| Sensitivity & Specificity | Validated with BBI low titre & Chinese FDA panels |
| Kit Size | 30 tests per kit |
| Storage | As per manufacturer guidelines |
| Use Classification | For professional use; not for self-testing |
Applications
- Point-of-care HIV screening and diagnosis
- Early detection of acute HIV infections
- Outreach and community health programs
- Emergency room and urgent care HIV testing
- Voluntary counseling and testing (VCT) sites
- Mobile and resource-limited healthcare settings
The HIV Ag/Ab 4th Gen. Rapid Test offers a sensitive, specific, and early detection solution for HIV using a simple fingerstick or venous sample. It supports fast, reliable screening and diagnosis at the point of care and is ideal for use in diverse clinical, field, or mobile environments where timely HIV detection is critical.