LEPU Medical Corona lay test at home CE0197 result in 15 minutes

Lepu Medical SARS-CoV-2 antigen test kit is used for COVID-19 antigen rapid test, based on specific antibody-antigen reaction and immunoassay technique to qualitatively detect the novel coronavirus (2019-nCoV) antigen in clinical specimen with rapid and accurate results.
Please note: this product is currently not authorized for sale or distribution in the U.S.
SARS-COV2 Antigen Rapid Test Card contains a gold-labeled novel coronavirus N protein monoclonal antibody pre-coated on the bonding pad and a paired novel coronavirus N protein monoclonal antibodies fixed in the test line (T) and corresponding antibodies in the quality control line (C).

SARS-COV2 Antigen Rapid Test Kit can detect the virus from the first phase of infection (2-3 days before potential symptom onset) to the last phase of infection (7-10 days after potential symptom onset).

• Used to test COVID-19 antigen
• Card-like format detects the nucleocapsid (N) protein of the virus.
• Gold-labelled SARS-CoV-2 N protein monoclonal antibodies immobilized on the test area, with corresponding antibodies in the quality control area.
• Swabbed specimens from the nasopharynx or oropharyngeal, result in 15 minutes.
• with CE certification CE0197
• Manufacturer certification TÜV EN 13485: 2016
• Box with 25 tests

Product Features

• Non-invasive
• Simple to use
• Convenient, no devices required
• Rapid, get a result in 15 minutes
• Stable, with high accuracy
• Inexpensive, cost-efficiency
• Evaluation duration 15 minutes.
• Clinical sensitivity 95.06%
• Clinical specificity 99.62%
• CI 95% sensitivity 91.57% - 97.15%
• CI 95% specificity 97.89% - 99.93%

Instruction & Result Interpretation

• Step 1: Use a swab to collect samples.
• Step 2: Peel off adhesive.
• Step 3: Insert swab from well B to well A.
• Step 4: Add 6 drops of buffer to well A rotate the shaft, two rounds each direction.
• Step 5: Fold the left side over, and wait for 15 minutes.