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Covid-19 antigen test individual

An immunochromatographic assay for the rapid qualitative detection of COVID-19 antigen in human nasopharyngeal swabs as an assistant for early diagnostic and epidemiological investigation.

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Certificate numberCE1434

Packing specification1T20T

Intended useThe reagent utilizes the principle of double antibody sandwich combines with colloidal gold immunochromatography.When an appropriate amount of the test sample is added into the sample hole of the test card, the sample will be move forward along the test card under the action of capillary. If the sample contains covid-19 antigen, the antigen will bind to the colloidal gold-labeled COVID-19 antibody. The immune complex forms a sandwich complex with another coated COVID-19 antibody at the detection line (T line), showing that the COVID-19 antigen is positive.

TEST PROCEDURE

1.  Remove test device from the sealed pouch just prior to the testing and lay flat on work bench.

2.  Reverse the sample extraction tube, and add 2 drops (about 70-80μl) of test sample by squeezing the extracted solution tube into the sample window.

3.   Read the result at 10-20 minutes. Do not interpret the result after 20 minutes.


Possible setting for the test: Home, workplace, physician’s office or clinical labs

Storage conditions and expiration date

1. The original package shall be stored at 2~ 35, and shall not be frozen. The validity period is 24 months from the date of verification and qualification.

2. The test paper should be used within 1 hour after the original aluminum foil bag is opened.


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