Rapid SARS-CoV-2 Blood Test Kit

The product is intended for the qualitative detection of antibody content against SARS-CoV-2 in clinical samples (serum/plasma/whole blood).
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Product Details


Production Summary


Coronavirus, as a large virus family, is a single positive stranded RNA virus with envelope.

The virus is known to cause major illnesses such as colds, Middle East Respiratory Syndrome (MERS), and Severe Acute Respiratory Syndrome (SARS). The novel virus, now known as SARS-CoV-2, was discovered in Wuhan virus pneumonia cases in 2019, and was officially named by the World Health Organization on January 12, 2020.

The core protein of SARS-CoV-2 is the N protein (nucleocapsid), which is a protein component located inside the virus. It is relatively conserved among β-coronaviruses and is often used as a tool for the diagnosis of coronaviruses. ACE2, as a key receptor for SARS-CoV-2 to enter cells, is of great significance for the research of viral infection mechanism.


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Measurement Principle


The product is based on the principle of antigen-antibody reaction and immunoassay technique. The test device contains colloidal gold labeled SARS-CoV-2 recombinant protein, mouse-anti human IgG antibody immobilized in G test area, mouse-anti human IgM antibody immobilized in M test area and the corresponding antibody in quality control area (C).

During the test, when the SARS-CoV-2 IgM antibody level in the sample is at or above the limit of detection of the test, the SARS-CoV-2 IgM antibody in the sample binds to the colloidal gold labeled SARS-CoV-2 recombinant protein which is pre-coated on a gold label pad.

The conjugates migrate upward through capillary effect and would be captured by mouse-anti human IgM antibody immobilized in M test area subsequently and this produces a purple-red band appears in the M test area. When the SARS-CoV-2 IgG antibody level in the sample is at or above the limit of detection of the test, the SARS-CoV-2 IgG antibody in the sample binds to the colloidal gold labeled SARS-CoV-2 recombinant protein which is pre-coated on a gold label pad.

The conjugates migrate upward through capillary effect and would be captured by mouse-anti human IgG antibody immobilized in G test area subsequently and this produces a purple-red band appears in the G test area.

If it is a negative sample, there is not a purple-red band appeared in the M and G test area.

Regardless of the presence or absence of the SARS-CoV-2 antibody in the sample, a purple-red band will appear in the quality control area (C).

The purple-red band in the quality control area (C) is a criterion for judging whether there is enough sample and whether the chromatography process is normal. It also serves as the internal control standard for reagents.



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.

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Test Method


Please read the instruction for use carefully before performing the test. Before testing, restore the reagents and blood sample to room temperature.

  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.

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Certificate


USFDA EUA - Application Letter_LI图片

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