Testing Methods for SARS-Cov-2
SARS-Cov-2 Antigen Test Kit(LFIA)
Swab Test (Infection)
Determines if someone is infected by detecting the presence of viral material.
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.
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.
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:
|Medomics COVID-19 Ag test||Positive||Negative||Total|
Limit of Detection (LoD) Study Results
|Concentration TCID 50/mL||Number Positive/ Total||% Detected|
|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)|