Covid-19 zelftest en sneltest

SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) 【 Summary 】 【 Intended Use 】 The product is intended for the qualitative detection of antigen against SARS-CoV-2 in clinical samples (nasal swab). 【 Model 】 1 test/kit; 5 tests/kit; 10 tests/kit; 25 tests/kit; 50 tests/kit. SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography) 【 Product name 】 Coronavirus, as a large virus family, is a single positive stranded RNA virus with envelope. The virus is known to cause major illnesses such as colds, Middle East Respiratory Syndrome (MERS), and Severe Acute Respiratory Syndrome (SARS). The core protein of SARS-CoV-2 is the N protein (Nucleocapsid), which is a protein component located inside the virus. It is relatively conserved among β-coronaviruses and is often used as a tool for the diagnosis of coronaviruses. ACE2, as a key receptor for SARS-CoV-2 to enter cells, is of great significance for the research of viral infection mechanism. 【 Principle 】 The current test card is based on the specific antibody-antigen reaction and immunoanalysis technology. The test card contains colloidal gold labeled SARS-CoV-2 N protein monoclonal antibody which is pre-coated on the combination pad, matched SARS-CoV-2 N protein monoclonal antibody immobilized on the Test area (T) and corresponding antibody in the quality control area (C). During testing, the N protein in the sample combines with the colloidal gold labeled 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 color 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 color 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. 【 Component 】 The 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), absorb- ing paper, and hydrophobic stiff card. The product consists of test cards, Instructions for use, sample treatment solution. And in each test card bag, it includes one SARS-CoV-2 antigen detection card and one package of desiccant. 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 Requirements 】 I t should be stored at 4℃~ 30℃, 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. 【 Storage and Stability 】 Please read the instruction for use carefully before performing the test. Before testing, restore the reagents and sample to room temperature. 1. Remove the test card from the test card bag and use it within 1 hour, especially in the environment with room temperature higher than 30 ° C or in high humidity. 2. Place the test card on a clean platform. Drip 5 drops of the sample treatment solution to well A. 3. Thread the swab head through the bottom of well B into well A and rotate it two rounds clockwise and counterclockwise respectively in the sample treatment solution. 4. Remove the protective cover of the fixing glue. Stick the left and right sides together and start timing. Wait until the purple band appears. The test result should be read within 15-20 minutes. 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 】 6ml 3 ml 2ml 1ml 1ml Sample treatment solution 1 1 1 1 1 Instructions for use 25 tests 50 tests 10 tests 5 tests 1 test Test card For each test 50 tests/kit Model 1 test/kit 5 tests/kit 10tests/kit 25 tests/kit card bag, it contains one test card and one package of desiccant.