Hangzhou Aichek Medical Technology Co.,Ltd
Hangzhou Aichek Medical Technology Co.,Ltd
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uncut sheet for covid-19 Antigen Rapid Test Kit with CE Certificate
| Product Name | uncut sheet for covid-19 Antigen Rapid Test Kit with CE Certificate |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Urine |
| Read Time | 5 minutes |
| Shelf life | 2 years |
| Package | uncut sheet |
| Storage | 2℃-30℃ |
The COVID-19 Antigen Rapid Test device is a lateral flow chromatographic immunoassay for the qualitative detection of the nucleocapsid(N) protein antigen from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab. It provides an aid in the diagnosis of infection with 2019-nCOV.
LIMITATIONS
The result of the test should not be taken as a confirmed diagnosis, for clinical reference only. Judgement should be made along with RT-PCR results, clinical symptoms, epidemiological information, and further clinical data.
The Test performance depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed on the same sample.
The test must be equilibrated to room temperature (18℃~26℃) before used, otherwise the results may be incorrect
A negative test result may occur if the level of antigen in a sample is below the detection limit of the test.
Failure to follow the Test Procedure may adversely affect test performance and/or invalidate the test result.
React less than 10 minutes may lead a false negative result; React more than 10 minutes may lead a false positive result.
Positive test results do not rule out co-infections with other pathogens.
Negative test results are not intended to rule in other viral or bacterial infections.
Negative results should be treated as presumptive and confirmed with a molecular assay.
Clinical performance was evaluated with fresh samples.
Users should test specimens as quickly as possible after specimen collection.
