Medomics SARS-CoV-2 Antigen Test Kit is user-friendly rapid antigen test, which can be used anytime, anywhere without the need of special equipment or facility. It is designed for qualitative detection of antigens in direct nasal swab samples, where the intuitive visual result will be shown in 15 minutes. The product is authorized by EU CE and Hong Kong Government for use. The rapid antigen test is clinically validated with overall sensitivity and specificity at 97% and 100% respectively.
Testing Method for SARS-CoV-2
- Nasopharyngeal Swab
- Throat Swab
- Nasal Swab
Test Procedure (only 4 steps)
- Collect nasal swab sample.
- Mix sample into the buffer solution.
- Add the buffer solution into the sample well.
- Read the result within 15-20 minutes.
CLINICAL PERFORMANCE
Sensitivity and Specificity
The Medomcis SARS-CoV-2 Antigen Test Kit (LFIA) was evaluated with different clinical samples whose status were confirmed by RT-PCR.1. Nasopharyngeal or throat secretion collection.
Sensitivity: 97.73%Specificity: 100%
2. Anterior Nasal secretion collection
Sensitivity: 91.82%Specificity: 100%
Limit of Detection (LoD) Study Results
| Concentration TCID50/mL | Number Positive/Total | % Detected |
|---|---|---|
| 10 | 20/20 | 100% |
| Manufacturer/ Company |
LoD | Positive Percentage |
|---|---|---|
| BD | 140 TCID50/mL | 95% (19/20) |
| Abbott | 22.5 TCID50/Swab | 100% (20/20) |
| Lumiradx | 32 TCID50/mL | 100% (20/20) |
| Medomics | 10 TCID50/mL | 100% (20/20) |
PACKING INFO
| Carton specifications |
Quantity | Carton dimension |
Gross weight in carton |
Carton volume |
|
|---|---|---|---|---|---|
| 1 tests/kit | 400kits/carton | 400 tests | 64 x 42 x 51cm | 13.9kg | 0.137m3 |
| 5 tests/kit | 160kits/carton | 800 tests | 64 x 42 x 51cm | 15.42kg | 0.137m3 |
| 20 test/kit | 50kits/carton | 1000 tests | 64 x 42 x 51cm | 15kg | 0.137m3 |
