7 Tests | SureScreen Diagnostics Covid 19 Lateral Flow Self Testing Kits | SARS-CoV-2 Antigen Rapid Test Cassette (Nasal Swab) (Gold)

INTENDED USE The SARS-CoV-2 Antigen Rapid Test Cassette (Nasal Swab – Gold) is a self-test rapid chromatography immunoassay for the qualitive detection of SARS-CoV-2 Antigens from anterior nasal swab specimens collected from individuals who are either symptomatic or asymptomatic. The identification is based on the monoclonal antibodies specific for the Nucleocapsid (N) protein of SARS-CoV-2. It is intended to aid in the rapid differential diagnosis of COVID -19 infections. SUMMARY The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. PRINCIPLE The SARS-CoV-2 Antigen Rapid Test (Nasal Swab) is a qualitative membrane-based immunoassay for the detection of SARS-CoV-2 nucleocapsid protein antigens in human swab specimen. WARNING Do not use after the expiration date. Please follow the expiration date on the box. The shelf life for this product is 24 months from manufacture. The cassette should remain in the sealed pouch until ready to use. These test kits are only designed for human use. Do not use any nasal sprays 15 minutes prior to testing. The product has not been made with natural rubber latex however the presence or traces of natural rubber latex in the product as delivered to the end-user cannot be excluded completely. Children under 3 years old should not use this device. Children under 12 years of age should be tested by an adult. Users with a nose bleed should not use this device. The extraction buffer contains materials which may create irritation if it comes into contact with the skin or eyes. If the solution contacts with the skin or eye, wash with excess water thoroughly. If irritation persists, please seek medical attention. STORAGE AND HANDLING Store as packaged at room temperature or refigerated at (2-30˚C). Do not freeze. Do not store in direct sunlight. The kit should be used at room temperature (15 C to 30˚C). If the kit has been stored in a cool area (less than 15˚C), leave it at normal room temperature for 20 minutes before using. Use a separate test kit for each person. You can only use each item in the test kit once. Do not re-use the items. If you have problems with your hands or vision, you may need someone to assist you with the swabbing and testing process. If you have a nose piercing, remove the piercing before conducting the test. Do not touch the swab head when handling the swab. Avoid touching the test kit and results window area where the sample is added. CONTENTS Test cassette x7 Sterile nasal swabs x7 Extraction buffer vials x7 Sample collection vials x7 Waste bag x7 Package insert x1 FREQUENTLY ASKED QUESTIONS 1. How does the SARS-CoV-2 Antigen Rapid Test work? The test is for the qualitative detection of SARS-CoV-2 antigens in self-collected swab specimens. A positive result indicates SARS-CoV-2 antigens present in the specimen. 2. When should the test be used? SARS-CoV-2 antigen can be detected in acute respiratory tract infection, it is recommended to run the test in symptomatic individuals meeting the case definition for COVID-19 (Acute onset of fever, cough; or Acute onset of ANY THREE OR MORE of the following signs or symptoms: Fever, cough, general weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnoea, anorexia/nausea/vomiting, diarrhoea, altered mental status.), and to test asymptomatic individuals limited to contacts of confirmed COVID-19 cases or probable cases and to at-risk health workers. 3. Can the result be incorrect? The results are accurate as far as the instruction