IVA 5% ai sensi dell’art. 124 D.L. 19 maggio 2020, n. 34 Parte II-bis 1-ter.1.
Registrazione Ministero della Salute: 1987147
Registrazione Ministero della Salute: 2004469
Sensibilità: 92% (Total coincidece rate 96,67%)
The product is intended for the qualitative detection of antigen against SARS-CoV-2 in clinical samples (nasal swab).
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.
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.
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 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.
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.
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.
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.
The Explanation of the Testing Results
• Positive (+): There appear purple stripes in both quality control area (C) and either test area (T).
• Negative (-): There is only one purple stripe in the quality control area (C), and without purple stripe in either test area (T).
• Invalid: There is no purple stripe in the quality control area (C), or there is blue stripe in the quality control area (C), indicating incorrect operating procedures or the test card has already deterio- rated. Under this condition, it must read the instruction for use again carefully, and then use the new test card to test again. If the problem still exists, stop using the products with same lot number and contact the local suppliers immediately.
Limitation of Procedure
1. The test results of this product should be comprehensively judged by the physician in combination with other clinical information, and should not be used as the only criterion;
2. The product is used to test the SARS-CoV-2 antigen of the clinical sample.