Active Member
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[China]
Address: 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District, 310018 Hangzhou, Zhejiang, P.R. China
Contact name:Edward YU
Hangzhou Aichek Medical Technology Co.,Ltd |
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Product Name | Antigen Covid 19 Self Swab Test Kit For Private Use |
Formats | Device(4mm) |
Place of Origen | China |
Specimen | Swab |
Read Time | 15 minutes |
Shelf life | 2 years |
Package | 25 device/box or 1Test/Box |
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.
[INTERPRETATION OF RESULTS]
POSITIVE RESULT: Two colored bands appear on the membrane. One bland appears in the control region (C) and another band appears in the
test region (T).
NEGATIVE RESULT: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).
INVALID RESULT: Control band fails to appear. Results from any test which has not produced a control band at the specified reading time
must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and
contact your local distributor.
[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.
