Covid-19 zelftest en sneltest

【 Explanation of Symbols 】 【 Basic information 】 Beijing Lepu Medical Technology Co., Ltd. Address: 3th Floor and 5th Floor Building 7-1 No.37 Chaoqian Road, Changping District, Beijing, 102200, P.R. China Tel: +86-10-80123964 Email: lepuservice@lepumedical.com Web: en.lepumedical.com Approval Date and Revision Date of the Instruction: Approved on 2nd, Sept., 2020; Version number: CE-InCG27 REV.01 Lepu Medical (Europe) Cooperatief U.A. Abe Lenstra Boulevard 36, 8448 JB, Heerenveen, The Netherlands Tel: +31-515-573399 Fax: +31-515-760020 • 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. 1 Physical Property 1.1 Appearance The test card should be clean and integral, no burrs, no damage, no pollution; the material should be firmly attached; the label should be clear and not damaged. The sample dilution should be clear without impurities and flocs. 1.2 Liquid migration speed The liquid migration speed should be no less than 10mm/min. 【 Product Performance Index 】 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. 【 Limitation of Procedure 】 1 .3 Membrane Strip Width The membrane strip width of the testing card should be≥2.5mm. 1.4 The preparation quantity of the diluent for the samples The volume of the diluents for the sample is no less than the indicated value. 2 Detection Limit For the detection of sensitivity reference material, the positive detection rate should be no less than 90%. 3 Negative reference products compliance rate For the detection of negative reference material, the negative detection rate should be 100%. 4 Positive reference products compliance rate For the detection of positive reference material, the positive detection rate should be 100%. 5 Repeatability For the detection of enterprise reference material P2 and P4, the results should be positive and the color rendering should be uniform. 6 Analytical Specificity 6.1 Cross-reactivity: This test device has no cross reactivity with endemicity human coronavirus OC43, influenza a virus, influenza B virus, respiratory syncytial virus, adenovirus, EB virus, measles virus, cytomegalovirus, rotavirus, Norovirus, mumps virus, varicella zoster virus, mycoplasma pneumoniae, Human metapneumovirus. 6.2 Interfering substances: The test results do not be interfered with the substance at the following concentration: bilirubin concentration ≤250 μmol/l; triglycerides concentration ≤ 15 mmol/l;hemoglobin concentration ≤10 g/dL; rheumatoid factor concentration ≤ 80RU/ml; anti-mitochondrial antibody concentra - tion≤80 U/mL; antinuclear antibody concentration ≤ 80U/mL; the total IgG concentration ≤14g/L. The test results do not be influenced by the following substance:α -interferon,zanamivir, ribavirin, oseltamivir, and parami- vir,Lopinavir, ritonavir, abidol, levofloxacin, azithromycin, ceftriaxone, meropenem, tobramycin, histamine hydrochloride, phenylephrine, oxymetazoline, sodium chloride (containing Preservatives), beclomethasone, dexamethasone, flunisolide, triamcinolone, budesonide, mometasone and fluticasone. 1. The test is only suitable for professionals to use in vitro auxiliary diagnosis. Do not use expired products. • Negative (-): There is only one purple stripe in the quality control area (C), and without purple stripe in either test area (T). • Positive (+): There appear purple stripes in both quality control area (C) and either test area (T). 【 The Explanation of the Testing Results 】】 2. Do not freeze or use after the expiration date (see the packaging for the expiration date). 3. Avoid excessive temperature and humidity in the experimental environment. The reaction temperature should be 15-30 ° C and the humidity should be below 70%. 4. The test card bag contains desiccant, and it should not be taking orally. 5. When testing, please wear protective clothing, medical mask, gloves and goggles. 6. Do not use the test card with broken single packaging, unclear marks, and past the expiration date. 7. Dispose of used specimens, test cards and other waste in accordance with relevant local laws and regulations. 【 Precautions 】