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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)

  1. Collect nasal swab sample.
  2. Mix sample into the buffer solution.
  3. Add the buffer solution into the sample well.
  4. 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
Single test kit 480 box/carton 480 test kits/carton 59cmx36cmx47cm 15.1kg 0.137m3
5 pcs test kit 192 box/carton 960 tests/carton 35cmx50cmx60cm 15.8kg 0.137m3
Family test kit 60 box/carton 1200 tests/carton 35cmx58cmx50cm 16.2kg 0.137m3