IFU-SARS CoV-2 Antigen test kit
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SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) For Rapid Detection of SARS-CoV-2. Kit configured for testing throat swab and nasal swab samples freshly collected.

SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) PRODUCT NAME SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) INTENDED USE This product is used for in vitro qualitative detection of novel coronavirus (2019-nCoV) antigens in human throat swabs and nasal swabs. This product is limited to medical institutions. The novel coronavirus belongs to the β genus. Novel coronavirus pneumonia is an acute respiratory infectious disease, and the population is generally susceptible. The main source of infection is the patients who has been infected by the novel coronavirus, and the asymptomatic...

STORAGE AND STABILITY The test device is sealed in an aluminum foil bag, which may be stored at 4℃~30℃ for 24 months. Once the aluminum foil bag is opened, please use it within 1 hour . WARNINGS AND PRECAUTIONS 1. For professional in vitro diagnostic use only. 2. Do not use the test kit if the pouch is damaged or the seal is broken. 3. 4. 5. 6. 7. Do not use this kit beyond the expiration date printed on the package label. To avoid erroneous results, specimens must be processed as indicated in the assay procedure section. Do not reuse any kit components. Proper specimen collection, storage...

TEST PROCEDURE Please read this instruction carefully before use. A) Place the test kit and sample to be tested at room temperature. B) Open the inner packaging of the test card and take out the test card; take 2 drops (about 100μL) of the processed sample and drop them vertically into the sample hole of the test card. C) Observe the test results after 15 minutes, and the results are invalid for more than 30 minutes. INTERPRETATION OF RESULTS 1. Positive result: If both the C-line and the T-line appear, it means that SARSCoV-2 antigen is detected, and the result is positive. 2. Negative...

PERFORMANCE CHARACTERISTICS Clinical Performance Clinical validation study of the SARS-CoV-2 Antigen Test Kit was conducted at three sites in China in 2020. Throat swabs and nasal swabs specimens were evaluated from 250 subjects. Out of the 250 samples, 101 subjects were COVID-19 cases confirmed positive by an RT-PCR assay while 149 subjects were confirmed PCR negative. All patients who were confirmed positive exhibited clinical signs or symptoms of COVID-19.Of the 101 positive samples, 99 were reactive on the SARS-CoV-2 Antigen Test Kit, and of the 149 negative samples, 148 were...

Cross-Reactivity Cross-reactivity for SARS-CoV-2 Antigen Test Kit was evaluated by testing a panel of high prevalence respiratory pathogens that could potentially cross-react with SARS-CoV-2 Antigen Test Kit. Each organism and virus was tested in triplicate. The final concentration of each organism is documented in the following table. Potential Cross-Reactant Human coronavirus 229E (heat inactivated) Human coronavirus OC43 Human coronavirus NL63 Adenovirus Human Metapneumovirus Parainfluenza virus 1 Parainfluenza virus 2 Parainfluenza virus 3 Parainfluenza virus 4 Influenza A Influenza B...