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CE ISO 13485 Saliva Antigen Rapid Test Kit For Coronavirus

Hangzhou Aichek Medical Technology Co.,Ltd
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Hangzhou Aichek Medical Technology Co.,Ltd

CE ISO 13485 Saliva Antigen Rapid Test Kit For Coronavirus

Country/Region china
City & Province hangzhou zhejiang
Categories Dyestuff Intermediates
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Product Details

Coronavirus Saliva Antigen Rapid Test Kit Public Health

Product NameCoronavirus Saliva Antigen Rapid Test Kit Public Health
FormatsDevice(4mm)
Place of OrigenChina
SpecimenSaliva
Read Time15 minutes
Shelf life2 years
Package25 device/box or I Test/Box
Storage2℃-30℃
 

[INTENDED USE]

The COVID-19 Antigen Home Test (Saliva) is a lateral flow chromatographic immunoassay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in saliva specimen directly from individuals within 7 days of symptom onset to suspect COVID-19 infection. The COVID-19 Antigen Home Test (Saliva) is intended for self-use or lay person testing in a non-laboratory setting.

 

[PRECAUTIONS]

●Read the COVID-19 Antigen Home Test (Saliva) instruction for use carefully before performing a test. Follow directions for use. Failure to follow directions may produce inaccurate test results.

●For in vitro diagnostic use only.

●Do not use after the expiration date. Do not use the test if the pouch is damaged or open. Do not reuse any kit components. Do not use with multiple specimens.

●Do not dismantle and touch the test window of the test cassette.

●Make sure there is sufficient light when reading and interpreting the test results.

●Avoid exposure of your skin, eyes, nose, or mouth to the solution in the extraction tube.

●Keep test kit and materials out of the reach of children and pets, before and after use. Do not eat any kit components.

●Do not open the kit contents until ready to use. If the test cassette is open for an hour or longer, invalid test results may occur.

●The test is intended to be read at 15~20 minutes. If the test is read before 15 minutes or after 20 minutes, false negative or false positive results may occur, and the test should be repeated with a new test cassette.

●Inadequate or inappropriate sample collection may yield false test result.

●Invalid results, indicated by no Control Line, can occur when an insufficient volume of sample solution is added to the test cassette. Gently squeeze the tube and dispense 3 drops of solution into the sample well of test device.

●You’d better use the reagent to hold a test at the temperature 2-30℃.

●The test results of this test kit are for preliminary screening and clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the user’s clinical manifestations and other laboratory tests.

 

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