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OnSite™ Duo HSV-1/2 IgG/IgM Rapid Test Kit, CE, 20 Tests
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Specifications:
| Application | Diagnostic Testing | ||
| Storage Temperature | Room Temperature | ||
| Product Type | Test Kit | Forms | Kit with Various components |
| Product Brand | CTK Biotech | ||
| Product Grade | Medical grade | ||
The OnSite Duo HSV-1/2 IgG/IgM Rapid Test CE is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of IgG and IgM antibodies to both Herpes Simplex Virus type 1 (HSV-1) and type 2 (HSV-2) in human serum, plasma, or whole blood. Utilizing HSV-1 glycoprotein G1 (gG1) and HSV-2 glycoprotein G2 (gG2), this test provides type-specific antibody detection to support clinical decision-making.
Results are available in just 10 minutes, making this CE-marked assay a valuable point-of-care diagnostic tool. By differentiating between IgG and IgM antibodies, the test helps clinicians distinguish acute or recurrent infections (IgM positive) from recent or past infections (IgG positive).
Key Features
- Dual detection: Simultaneously detects antibodies to HSV-1 and HSV-2.
- Differentiates IgG and IgM antibodies to indicate acute vs. past infection.
- Type-specific detection via glycoproteins G1 (HSV-1) and G2 (HSV-2).
- High clinical accuracy with strong agreement to ELISA and reference panels.
- Rapid results in 10 minutes, suitable for immediate treatment decisions.
- Multiple specimen compatibility: serum, plasma, and whole blood.
- Long shelf life (24 months at 2–30°C), portable and easy to store.
Clinical Performance
| Marker | Sensitivity | Specificity | Comparison Method |
|---|---|---|---|
| Anti-HSV-1 IgG | 90.6% | 91.4% | Commercial ELISA |
| Anti-HSV-2 IgG | 93.8% | 96.0% | Commercial ELISA |
| Anti-HSV-1 IgM | 85.0% agreement | — | Commercial ELISA |
| Anti-HSV-2 IgM | 100% agreement | — | BBI Panel (PTH202) |
- Cross-reactivity: None with H. pylori, Dengue, Malaria, Typhoid, Toxoplasma, Rubella, CMV, HIV, HAV, HBV, HCV, HEV, TB, hCG, ANA, HAMA, or RF (≤1000 IU/mL).
- No interference with Albumin, Hemoglobin, Bilirubin, Heparin, Creatinine, Glucose, and other common substances.
Kit Contents
Each kit (20 tests) contains:
- One cassette device (per pouch).
- One desiccant.
- Capillary tubes (10 µL).
- Sample diluent (REF SB-R0203, 5 mL/bottle).
- Package insert (instructions for use).
Specifications
| Parameter | Details |
|---|---|
| Product Name | Duo HSV-1/2 IgG/IgM Rapid Test CE |
| Catalog Number | R0218C |
| Format | 20 tests/kit |
| Specimen Type | Serum (S), Plasma (P), Whole Blood (WB) |
| Detection | IgG and IgM antibodies to HSV-1 & HSV-2 |
| Antigens Used | Glycoprotein G1 (HSV-1), Glycoprotein G2 (HSV-2) |
| Principle | Lateral Flow Chromatographic Immunoassay |
| Turnaround Time | 10 minutes |
| Shelf Life | 24 months at 2–30°C |
| Regulatory Status | CE-marked |
Applications
- Screening and preliminary diagnosis of HSV-1 and HSV-2 infections.
- Differentiation of acute vs. chronic infections (IgM vs IgG).
- Point-of-care use in hospitals, diagnostic labs, and sexual health clinics.
- Epidemiological surveillance of HSV-1/2 prevalence.
- Support tool for STI and public health programs.
The OnSite Duo HSV-1/2 IgG/IgM Rapid Test CE provides a fast, reliable, and type-specific solution for detecting and differentiating antibodies to both HSV-1 and HSV-2. With its glycoprotein G1/G2 specificity, excellent clinical accuracy, and CE approval, this dual test is a powerful diagnostic tool for healthcare providers. Its ease of use, multiple specimen compatibility, and rapid turnaround make it ideal for point-of-care testing, clinical laboratories, and public health surveillance programs.