Lepu SARS-CoV-2
Antigen Rapid Test Kits

Based on preliminary layman study, all 110 samples of the laypersons which have been tested with RT-PCR have been negative in both tests, that means that the result of the antigen-test could be confirmed for all 110 samples; of the 135 positive results from 27 laypersons, the overall positive agreement rate is 97.78%. However, individual antigen test result of this product should be combined with other clinical information and comprehensively judged by physicians, and should not be used as the sole criterion in COVID-19 diagnosis. In particular, negative results do not rule out COVID-19 infection and it may be necessary to obtain additional testing with a molecular assay, if needed for patient management. 

While both types of Lepu's SARS-CoV-2 test kits offer rapid antigen testing based on the colloidal gold immunochromatographical technology, the self-testing version is designed to serve the needs of consumers who prefer to perform rapid antigen testing in a home setting and is made available for purchase over the counter, whereas non-self-testing version is designed for medical specialists to use in a clinical setting. 

All authentic Lepu Antigen Rapid Test for self-testing kits carry a light-blue label with miniature Lepu logo, anti-counterfeiting shading, regiment floral pattern, gilding, and temperature-sensitive ink used for fire discoloration. By scratching the covered bottom part of the label, you will find a unique code used for our online authenticity check-up system (https://en.lepumedical.com/).

The rapid antigen test package includes 1 test/kit, 5 tests/kit, or 25 tests/kit. Along with the test card(s) also comes illustrated instruction card, operation card, disposable sterile swabs, and sample treatment solution. 

You will first perform lower nostril nasal swab (2~3cm) in both nasal cavities. Then, you will insert your swab with sample into the testing card, add sample treatment solution to it, and then rotate the swab until fully mixed. The result will come out after 15~20 minutes. A more detailed instruction can be found on the illustrated instruction card included in your package. 

The result window consists of a "control" line and a "test" line. When both lines turn purple-red, however faint the color on the "test" line is, it is a positive result, which means you may have COVID-19. When only the "control" line turns purple-red, it is a negative result, which means SAR-CoV-2 was not found in this sample. If the "control" line shows no color or blue color, it is an invalid result, which means either the operation process is incorrectly done or the test paper has been damaged. If you have trouble determining the test result, please refer to the illustrations on your instruction card. 

After tested positive, you should inform your health care provider of the result. Your healthcare provider will work with you to further confirm the diagnosis of COVID-19 and determine how best to care for you. You should also continue following the public health protocol in place in your local area. In general, it is advised that one should abstain from visiting public space and only leave home to obtain necessary medical care.

False negative results could be due to various reasons, including but not limited to: 

(1) the level of antigen in the sample is below the detection limit of the test; 

(2) a specimen is improperly collected or handled; 

(3) inadequate or excessive amount of sample treatment solution is used; 

(4) swabs are not twirled properly within the test card; 

(5) test card is moved or disturbed in the waiting process; 

(6) test result is read before 15 minutes; 

(7) the tested individual has more than seven days of symptoms; 

(8) the tested individual is taking mupirocin. 

The test kit is valid for 18 months when stored in a dry and dark place with temperature of 4-30℃ and humidity of less than 70%. The test card must be used within one hour after it is taken out from the aluminum foil bag. The sample treatment solution should be used immediately after opening. Please consult package label for dates of manufacture and expiration. 

Please dispose of all used specimens, test cards, and other waste in accordance with relevant local laws and regulations. The box and instruction card may be recycled if they have not been contaminated.

Should you have other questions and feedback regarding the Lepu self-testing kits, please contact our 24/7 customer service team: customerservice@lepu-medical.com