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Rapid igg igm serological tests for SARS-CoV-2 research (Kit 40 Tests) Roche

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Description

Roche Kit 40 SARS-CoV-2 Rapid IgG IgM Tests

The SARS-CoV-2 Rapid Antibody Test includes three pre-coated lines (the “C” control line and the “G” and “M” test lines) on the surface of the nitrocellulose membrane of the test strip. The control line and the two test
The control line and the two test lines are not visible in the result window until the sample is applied. The region of the control line is coated with an IgY monoclonal antibody, while the region of the “G” and “M” test lines are coated with an IgY monoclonal antibody.
with a monoclonal anti-human IgG antibody and a monoclonal anti-human IgM antibody.

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And the anti-IgY antibodies, conjugated with colloidal gold particles, act as detectors for the control line “C”. During the assay, SARS-CoV-2 virus-specific antibodies present in the sample interact with the recombinant SARS-CoV-2 protein
recombinant protein conjugated to colloidal gold particles, resulting in a gold-antibody-antigen complex. This complex migrates across themembrane by capillary action, to the “M” and “G” test line.

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Here it is captured by the monoclonal anti-human IgG antibody or the monoclonal anti-human IgM antibody. If SARS-CoV-2 specific antibodies are present in the sample, a colored test line appears in the result window.
The intensity of the color of the test line will vary depending on the amount of SARS-CoV-2 specific antibodies present in the sample. If no SARS-CoV-2 specific antibodies are present in the sample, the test line will not be colored. The control line, which serves a verification function of the procedure, should always appear to confirm that the test has been performed correctly and the test control reagents are working.

The test line is not colored.

Reagents

  • Human monoclonal anti-IgM
  • Human monoclonal anti-IgG
  • IgY
  • Anti-SARS-CoV-2 monoclonal nucleocapsid protein
  • Recombinant anti-SARS-CoV-2 nucleocapsid protein-gold conjugate
  • Recombinant gold-protein spike conjugate-SARS-CoV-2
  • Anti-IgY Monoclonal Antibodies

1. Running the test

After application of the whole blood sample, the test result will be available in 10-15 minutes. During this time, a 4-step sequence is performed to produce the test result.

Step 1..

A special tissue is used to separate the solid components of the blood from the liquid phase, the plasma. The residual plasma and buffer solution can drain through the membrane of the test strip.

Step 2

The anti-SARS-CoV-2 IgM and IgG in the sample interact with gold particle-conjugated antigens. Result: an antibody-antigen-gold-particle complex.

Step 3

The complexes thus formed migrate towards the analytical lines “M” and “G”. If IgM and/or IgG antibodies are present in the sample, the respective complexes bind specifically to the corresponding analytical line. The gold particles
allow visible staining of the analytical line.

Step 4

The third line that appears is the control line. It is used as a process control. It appears when the analytical procedure has been correctly performed and the analytical reagents of the control line are working properly.

Once the entire process is completed, the test result can be read in 10-15 minutes. It is positive if the control line and at least one of the two analytical lines “M” or “G” are formed.

Do not read the test before 10 minutes or after 15 minutes to avoid falsifying the result!

2. Testing with Capillary Whole Blood

1. Use a capillary tube to draw 20 µl of capillary whole blood, filling the tube to the black line.
2. After collecting the capillary whole blood,apply it to the sample well of the test strip.
3. Add 3 drops (90 µl) of buffer vertically into the sample well of the test strip. Do not touch the surface of the sample well with the tip of the bottle.
4. Read the test result after 10-15 minutes. WARNING! Risk of incorrect results. Do not read the test result if more than 15 minutes have elapsed.

3. Testing with serum, plasma or venous whole blood

1. Use a micropipette to take 10 µl of serum or plasma (A, B) or 20 µl of whole venous blood (C).
2. After collecting 10 µl of serum or plasma (A, B) or 20 µl of whole venous blood (C), apply it to the sample well of the test strip.
3. Add 3 drops (90 µl) of buffer vertically into the sample well of the test strip. Do not touch the surface of the sample well with the tip of the bottle.
4. Read the test result after 10-15 minutes. WARNING! Risk of incorrect results. Do not read the test result if more than 15 minutes have elapsed.

4. Interpretation of results

1. A colored strip appears at the top of the result window to indicate that the test is working correctly: it is control line (C).
2. In the lower part of the result window appear
colored stripes appear in the lower part of the result window: these are the IgG/IgM test lines (M, G).
3. Even if the control line is just faint, or if the test line is not uniform, the test can be considered correct and the result can be interpreted as a positive result.
be interpreted as a positive result.

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