SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)
The product is intended for the qualitative detection of antigen against SARS-CoV-2 in clinical samples (nasal swab). The test has two central advantages: the swab only needs to be inserted into the front area of the nasal cavity and does not require a throat smear – which is why the test can be carried out by everyone conveniently. The current test card is based on the specific antibody-antigen reaction and immunoanalysis technology.
Announcement by the Austrian Federal Ministry of Education, Science & Research: “Antigen self-tests for all students – result in just 15 minutes”
Quality confirmed by the Paul Ehrlich Institute:
Comparative evaluation of the sensitivity of SARS-CoV-2 rapid antigen tests by the Paul Ehrlich Institute (PEI)
The results of Lepu Medical’s SARS-CoV-2 Antigen Rapid Test are officially recognized in 27 EU Countries: Official recommendation of the EU Commission
During testing, the N protein in the sample combines with the colloidal gold labelled SARS-CoV-2 N protein monoclonal antibody which is pre-coated on the combination pad. The conjugates migrate upward under capillary effect, and subsequently captured by the N protein monoclonal antibody immobilized in the Test area (T). The higher the contents of N protein in the sample, the more the conjugates captures and the darker the colour in the test area is. If there is no virus in the sample or the virus content is lower than the detection limit, then there is no colour demonstrated in the test area (T). Regardless of the presence or absence of the virus in the sample, a purple stripe will appear in the quality control area (C). The purple stripe in the quality control area (C) is a criterion for the judgment of whether or not there is enough sample and whether or not the chromatography procedure is normal.
Sample Type: Human Nasal Swab
Application: Rapid Chromatographic Immunoassay
Quantity: 25 Tests/Kit
Duration: Results available in 15 mins
Storage Conditions: 4-30°C
• 25 Test Cards
• 1 IFU
• Sample Treatment Solution – 3ml x 2
• 25 Extraction Buffer Vials
Test Card Consists of:
• Gold Standard Mat (coated with colloidal gold labelled SARS-CoV-2 N protein monoclonal antibody)
• Sample Mat
• Nitrocellulose Membrane (Test Area (T) is coated with an SARS-CoV-2 N protein monoclonal antibody; the quality control area (C) is coated with goat anti-mouse antibody)
• Absorbing Paper
• Hydrophobic Stiff Card
During sampling, the swab head should be completely inserted into the nasal cavity and gently rotated 5times. After removal, the swab head should be sampled in the other nasal cavity in the same way to ensure that enough samples are taken.
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.
Thread the swab sample through the bottom of well B into well A. Add 6 drops of the diluent into well A. Do not drop the diluent into the other wells. Rotate the shaft ,two rounds each direction.
During the test, the test card should be placed on the horizontal desktop. The test card should be fixed and do not remove the test card.
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.