Testing Methods for SARS-Cov-2
SARS-Cov-2 Antigen Test Kit(LFIA)
Nasal/Throat
Swab Test (Infection)
Determines if someone is infected by detecting the presence of viral material.
How does the virus infect the cell
For the virus to invade the human cells, it needs to attach to the ACE2 receptor with the receptor binding domain (RBD) of the Spike protein.
If this interaction is blocked, with a Neutralizing/blocking antibody, the virus can not invade the cell.
Test design and principle
Colloidal gold-labeled anti-SARS-CoV-2 antibody and quality control antibody are sprayed on conjugation pad.
Test line is fixed with anti-SARS-CoV-2 antibody for detecting the novel coronavirus. The quality control antibody is fixed on the Control line.
Clinical Performance
Sensitivity and Specificity
The Medomics COVID-19 Ag test was evaluated with clinical samples whose status was confirmed by RT-PCR. The results are shown in the following table:
| RT-PCR | |||
|---|---|---|---|
| Medomics COVID-19 Ag test | Positive | Negative | Total |
| Positive | 215 | 2 | 21 7 |
| Negative | 5 | 405 | 412 |
| Total | 220 | 407 | 627 |
- Sensitivity:97.73%(94.78%-99.26%)
- Specificity:99.51%(98.24%-99.94%)
- Positive Predictive Value: 99.08%(96.71%~99.89%)
- Negative Predictive Value:98.78%(97.18%~99.60%)
- General match:98.88%(97.71%-99.55%)
Limit of Detection (LoD) Study Results
| Concentration TCID 50/mL | Number Positive/ Total | % Detected |
|---|---|---|
| 10 | 20/20 | 100% |
| Manufacturer / Company | Estimated LOD | % Positive |
|---|---|---|
| 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 specification
Container Load Capacity
Products are usually shipped by air, and the quantity of container loading information is only FYI.
20’GP, Approximately 81,600 tests
40’GP, Approximately 174,400 tests
40’HC,Approximately 218,000 tests
