COVID-19 IgM Antibody Rapid Test Kit

INTENDED USE

The reagent is used to detect the Corona Virus-19 IgM Antibody in serum/plasma/whole blood qualitatively.



TEST PRINCIPLE

This kit is based on the principle of gold label immunochromatographic test and uses capture method to detect the COVID-19 IgM antibody in the sample.


When the sample contains the COVID-19 IgM antibody, it forms a complex with the gold label antigen (COVID-19 recombinant antigen). The complex moves forward under the action of chromatography and combines with the coated antibody (Mouse anti-human IgM monoclonal antibody) at the T line to form a complex and develop color (T line), which is a positive result. When the sample does not contain the COVID-19 IgM antibody, no complex can be formed at the T line, and no red band appears, which is a negative result. 


Regardless of whether the COVID-19 IgM antibody is contained in the sample, the gold label quality control antibody (rabbit IgG antibody) will bind with the coated antibody (goat anti-rabbit IgG antibody) at the C line to form a complex and develop color (C line).


MAIN COMPONENTS

Cassette: T-line coated with mouse anti-human IgM monoclonal antibody, gold label pad solid phase COVID-19 recombinant antigen, rabbit IgG antibody, C-line coated with goat anti-rabbit IgG antibody 


Sample dilution: composed of 20 mM phosphate buffer solution (PBS)


TEST METHODS

Instructions must be read entirely before taking the test. Allow the test device controls to equilibrate to room temperature for 30 minutes (20℃-30℃) prior to testing. Do not open the inner packaging until ready, it must be used in one hour if opened (Humidity≤60%, Temp: 20℃-30℃). Please use immediately when the humidity>60%.


For Serum/Plasma

1. Remove the test cassette from the sealed pouch, place it on a clean and level surface with the sample well up.

2. Add one (1) full drop of serum or plasma (10μl) vertically into the sample well.

3. Add two (2) drops (80-100μl) of sample buffer into the sample well.

4. Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.

For Whole Blood

1. Remove the test cassette from the sealed pouch, place it on a clean and level surface with the sample well up.

2. Add two (2) full drops of whole blood (20μl) vertically into the sample well.

3. Add two (2) drops (80-100μl) of sample buffer into the sample well.

4. Observe the test results immediately within 15~20 minutes, the result is invalid over 20 minutes.

INTERPRETATION OF RESULTS

POSITIVE: Two distinct red lines appear. One line should be in the control region (C) and the other line should be in the test region (T).

NEGATIVE: One red line appears in the control region(C). No red or pink line appears in the test region (T).

INVALID: No red lines appear or control line fails to appear, indicating that the operator error or reagent failure. Verify the test procedure and repeat the test with a new testing device.

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