Antigen Test Kit (LFIA)

Coronavirus Antigen Rapid Test Kit
1/5/20 tests/kit

Packing size

Nasal swabs, Throat swabs, BALF

Specimen type



24 months

Shelf Life

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.

pcr antigen andibody

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.

How does the virus infect 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.

Test design and principle

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:

Medomics COVID-19 Ag testPositiveNegativeTotal
Positive215221 7
  • 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/mLNumber Positive/ Total% Detected
Manufacturer / CompanyEstimated LOD% Positive
BD140 TCID50/mL95% ( 19/20)
Abbott22.5 TCID50/Swab100% (20/20)
LumiraDx32 TCID50/mL100% (20/20)
Medomics10 TCID50/mL100% (20/20)



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Clinical Performance & Instruction for Use

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