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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. It's strictly forbidden to advertise, marketing and resell to any U.S. customers or U.S. territories.
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.
• Non-invasive
• Simple to use
• Convenient, no devices required
• Rapid, get a result in 15 minutes
• Stable, with high accuracy
• Inexpensive, cost-efficiency
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.
Product | Model | Specifications | Carton Size | Weight/Carton | Packaging/Carton |
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) | CG27 | 1 test / kit | 59*31.5*50cm | 10.05kg | 150 tests |
5 tests / kit | 12.4kg | 380 tests | |||
10 tests / kit | 13.7kg | 450 tests | |||
25 tests / kit | 13.35kg | 450 tests |
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.
Result Interpretation:
| Positive | Negative | Invalid |
 |  |  |
On March 23, Lepu SARS-CoV-2 Antigen Test Kit was granted special approval by the German Federal Institute for Drugs and Medical Devices (BfArM) for self-testing in Germany. This allows the users to apply tests at home with the aid of sample nasal swabs.
The rapid antigen test is easy to operate compared with PCR testing. It collects the sample from nasopharynx. Users can test by themselves at home where they might feel most comfortable. By following simple instructions, they can get the results ready in 15 minutes.
On March 17, the European Center for Disease Prevention and Control published an announcement regarding the public’s usage of self-tests to detect SARS-CoV-2. “From a public health perspective, self-tests can offer advantages when used to complement professionally administered RADTs or RT-PCR tests. They can improve the accessibility to testing. They allow individuals to obtain the result very quickly, which could support the early detection of infectious cases and reduce further community transmission.”
So far, Lepu's anti-covid-19 products have reached over 147 countries worldwide. This time, Lepu home-use antigen test kits facilitated disease control process in Germany and would continue to support that within Europe soon.
View more details of Lepu Covid-19 related products.
| Catalogue No. | SARS-CoV-2 Antigen Rapid Test Kit | CE |
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