Lepu medical sars-cov-2 antigen rapid test kit anleitung

The product consists of test cards, Instructions for use, sample treatment solutions. And in each test card bag, includes one SARS-CoV-2 antigen detection card and one package of desiccants.

Model

Sample treatment solution

Each test card bag contains one test card and one package of desiccants.

The test card consists of a gold standard mat (coated with colloidal gold-labeled SARS-CoV-2 N protein monoclonal antibody), sample mat, nitrocellulose membrane (Test area (T) is coated with a SARS-CoV-2 N protein monoclonal antibody; the quality control area (C) is coated with goat anti-mouse antibody), absorbing paper, and hydrophobic stiff card.
Storage and Stability 
It should be stored at 4°C~ 30°C, be kept dry and away from sunlight. The shelf life is 12 months.
For per test card, it should be used within 1 hour after unsealing.
Production Date and Expiration date are shown in the package label.
Sample Requirements 
The product is used to test the human nasal swab sample.
Sample collection: During the collection procedures for samples, take care to make proper protection, and avoid direct contact with the sample. In case of accidental contact, disinfection treatment should be carried out in time and necessary measures should be taken.
Nasal swab sample: gently and slowly insert the swab into the nasopharynx through the nasal cavity. When resistance is encountered, the swab will arrive at the posterior nasopharynx. After a few seconds of suction, gently rotate the swab, then take out the swab to obtain the nasal swab sample.
Sample preservation: after sample collection, please complete the test within 1 hour.
The sample should come to room temperature before testing.

Test Method 

Please read the instruction for use carefully before performing the test. Before testing, restore the reagents and sample to room temperature.

1. During sampling, the swab head should be completely inserted into the nasal cavity and gently rotated 5 times. After removal, the swab head should be sampled in the other nasal cavity, in the same way, to ensure that enough samples are taken.
2. Before the test, the double-sided adhesive protective layer should be removed in advance to prevent liquid splashing. If the double-sided adhesive protective layer is torn off after adding diluent, it is easy to cause liquid splashing.
3. Add 6 drops of the diluent into well A. Do not drop the diluent into the other wells.
4. During the test, the test card should be placed on the horizontal desktop. The test card should be fixed and do not remove test card.
5. After covering the left side, gently press the adhesive position to make the two sides completely fit and start timing. Wait until the purple band appears. The test result should be read within 15-20 minutes.

• 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.

Antigen Test Kit Colloidal Gold Features

• Non-invasive

• Simple to use

• Convenient, no devices required

• Rapid, get a result in 15 minutes

• Stable, with high accuracy

• Inexpensive, cost-efficiency

Lepu Medical Antigen Rapid Test Colloidal Gold Related News

On 26th Jan 2021, report from PEI of an official test that The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) authorized to perform, declared that Lepu Medical SARS-CoV-2 Antigen Rapid Test Kit has fulfilled all the minimum criteria for antigen tests conducted by PEI in consultation with the Robert Koch-Institut (RKI).

In March 2021, German BfArM approved Lepu Medical SARS-CoV-2 antigen rapid test kit for home use. The test kit makes the coronavirus detection procedures rapid and easy.