Beijing LEPU Medical Anti-body Coronavirus Test Kits

Beijing LEPU Medical Anti-body Coronavirus Test Kits

Rapid Covid-19 test kits. Medical CE Mark FDA. Over 99% Analytical Accuracy. IFU user manual in English,Spanish and Portuguese. Professional Use Coronavirus Test Kits
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Product Details

Covid-19 Test Kits

THE DISEASE

Coronavirus Disease 2019(COVID-19 is an acute infectious disease caused by the 2019 novel coronavirus(SARS-CoV-2).


THE ANTIBODY TEST

Quick Profile TM 2019-nCoV IgG/lgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of lgG and IgM antibodies to the 2019 novel coronavirus(2019-nCoV, SARS-CoV-2) in human serum, plasma or whole blood.

Quick Profile TM 2019-nCoV IgG/lgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus.


Components

The product contains 20 tests, one IFU (instruction for use) and one lot number card.  

For each test, it contains one testing strip, one dropper and one  package of desiccant. 

The testing strip is composed of one gold standard mat (colloidal  gold labeled SARS-CoV-2 recombinant protein), sample mat,  cellulose nitrate membrane (Mouse-anti human IgM antibody  immobilized in M area, Mouse-anti human IgG antibody  immobilized in G area; Goat anti-mouse antibody immobilized in C area), absorbing paper, plastic carrier board.


【Test Method】 

1. Remove the test strip from the packaging reagent bag and  use it within 1 hour, especially in an environment with room temperature higher than 30 ° C or in high humidity. 

2. Place the kit on a clean platform. 

⚫ Serum or plasma sample: Add 10 uL of serum or  plasma sample to well A, and then add two drops  (about 80 uL) of sample dilution to well B, and start  timing. 

⚫ Whole blood sample: Add 20 uL of whole blood  sample to sample well A, and then add two drops  (about 80 uL) of sample dilution to sample well B,  and start timing. 3. Wait for the fuchsia band to appear. The test results should  be read within 10-20 minutes. Do not read the results after  20 minutes.

【The Explanation of the Testing Results】

⚫ Positive (+): There appear purple stripes in both  quality control area and either area M or G. 

⚫ Negative (-): There is only one purple stripe in the quality control area (C), and without purple stripe in  either test area M and test area G. 

⚫ Invalid: There is no purple stripe in the quality control  area (C), indicating incorrect operating procedures or  the testing strip has already deteriorated. Under this  conditions, it must read the instruction for use again  carefully, and then use the new test strips to test again.  If the problem still exists, stop using this lot number  immediately and contact the local suppliers.



anti body test kit Covid-19


Feel Free to Contact Us for More Information

  1. TUV Test Report

  2. Medical CE certification 

  3. IFU User Manual 

  4. Clinical Report for SARS-CoV-2 or COVID-19 TEST

  5. Testing Video

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