GenSure COVID-19 Antigen Rapid Test Kit (Nasal & Saliva)
The GenSureTM COVID-19 Antigen Rapid Test Kit (Nasal & Saliva) is a polymer immunochromatographic double antibody sandwich technology test. It is intended for the direct qualitative detection of the N-protein antigen from SARS-CoV-2. Its use is limited to laboratories and medical institutions. Both human saliva and nasal swab specimens can be used for the test.
Generally
Advantages of the GenSure™ COVID-19 Antigen Rapid Test Kit (Nasal & Saliva)
- Suitable for both nasal and saliva samples
- Easy-to-use
- Less than 20 minutes from sample to result
- All needed materials included in the kit
- Storage at room temperature
Excellent performance
- Compared to PCR nasal swab sensitivity 96.86% (95% CI= 93.29% ~ 98.84%) and specificity 100.00% (95% CI= 98.97% ~ 100.00%)
- Compared to PCR saliva swab sensitivity 96.73% (95% CI= 92.54% ~ 98.93%) and specificity 100.00% (95% CI= 98.38% ~ 100.00%),
- N-protein detection
- Evaluated and approved for use by several EU member state authorities, such as Germany
- GenSure™ COVID-19 Antigen Rapid Test Kit (Nasal & Saliva)
Test should not be used as sole basis to diagnose or exclude SARS-CoV-2 infection. Antigen test sensitivity after the first five days of the onset of symptoms decreases compared to a RT-PCR SARS-CoV-2 assay.
Technical data
| Products available | P2004s GenSure™ COVID-19 Antigen Rapid Test Kit (Nasal & Saliva), 20 tests |
| Method | Polymer immunochromatographic and double antibody sandwich, qualitative |
| Sample type | Anterior nasal swab, saliva swab |
| Time to result | 15 minutes |
| Result display | Visual |
| Sensitivity | 97% compared to PCR |
| Specificity | 100% compared to PCR |
| Storage | 4 - 30 °C |