BIOEASY Diagnostic Kit for Coronavirus (COVID-19) Ag Test Kit

GENERAL INFORMATION Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) is the name given to the 2019 novel coronavirus. COVID-19 is the name given to the disease associated with the virus. SARS-CoV-2 is a new strain of coronavirus that has not been previously identified in humans. The 2019-Novel Coronavirus belongs to the genus β. It has a capsule, and its particles are round or oval, often polymorphous, with a diameter of 60-140nm. Its genetic characteristics are significantly different from SARS-CoV and MERS-CoV. BIOEASY Diagnostic Kit for Novel Coronavirus (COVID-19) Ag Test Kit is suitable for in vitro qualitative detection of 2019-Novel Coronavirus ( COVID-19 ) antigens in human naso- and oropharyngeal swabs and deep sputum samples by fluorescence immunochromatographic analysis to detect the nucleic capsid protein of SARS-CoV-2 . It is used for the auxiliary diagnosis of whether the patient is infected with the COVID-19 and other related diseases. REAGENTS AND MATERIALS SUPPLIED Test devices with desiccant in individual foil pouches 1 Sample Extraction buffer 25 Extraction Tube with drip head 1 Extraction Tube Holder 1 ID chip 1 Instructions for use PRINCIPLE OF THE TEST This kit uses the principle of double antibody sandwich reaction and fluorescent immunochromatographic analysis technology to qualitatively detect COVID-19 antigen in human nasopharyngeal swab, oropharyngeal swabs and deep sputum samples. During the test, if the test sample contains COVID-19 antigen, the COVID-19 antibody labeled with fluorescent particles binds to the COVID-19 antigen in the sample to form reaction complex, the reaction complex moves forward along the nitrocellulose membrane under the action of chromatography, and binds to the COVID-19 coated antibody pre-coated in the detection zone (T), to form double antibody sandwich, and finally form a reaction line with a fluorescent signal in the T region; Instead, when detect negative samples, no fluorescence signal reaction line was formed in the T region. Regardless of whether the sample to be tested contains the COVID-19 antigen, the control area (C) will аlways form a fluorescence reaction line. The detection card is detected by the matching fluorescent immunoanalyzer, and the result is interpreted. PERFORMANCE CHARACTERISTIC POSITIVE JUDGEMENT VALUE The positive judgment threshold of this product is 0.005ng / mL. The positive judgment value is only a reference guide for clinical diagnosis. The test results only reflect the current state of the sample. The diagnosis must be comprehensively evaluated in combination with clinical symptoms and other experimental results. It is recommended that each laboratory establish its own reference range based on actual conditions. Video instructions: CE-IVD certificated