Product Name: COVID-19 New Coronavirus IgG/IgM rapid screen Test Cassette
Accessories: Instruction for use, buffer, pipette
Intended Use:
The COVID-19 IgM/IgG Test is used for qualitative detection of
novel coronavirus IGM/IGG antibodies in human serum, plasma and
whole blood. After infection with the novel coronavirus, the common
signs include respiratory symptoms, fever, cough, wheezing and
dyspnea, etc. In more severe cases, the infection can lead to
pneumonia, severe acute respiratory syndrome, kidney failure and
even death. Coronaviruses can be expelled from the body through
respiratory secretions, transmitted by oral fluids, sneezing,
contact, and by airborne droplets.
TEST PRINCIPLE
The COVID-19 (Sars-CoV-2) IgM/IgG Test is the colloidal gold
labeled rabbit IgG and the novel coronavirus (Sars-CoV-2) antigen,
while the nitrocellulose membrane is coated with anti-human IgG and
sheep anti-rabbit IgG combined to form a band. The principle of
colloidal gold immunochromatography indirect method is used to
detect the novel coronavirus (Sars-CoV-2) IgM/IgG antibody in human
serum.
TEST PROCEDURE
1. Bring the pouched test device to room temperature(15-30℃) prior
to testing. Do not open pouch until ready
to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat,
clean and dry surface.
3. Use the pipette to draw and slowly add 1 drop of whole
blood/serum/plasma to the sample well.
4. Hold the buffer vertically and add 1 drop to the sample well.
/If using a pipette, change a new one to avoid
cross-contamination. Draw and transfer 2 drops of buffer to the
sample well.
5. Interpret test results within 10-15 minutes. Do not interpret
after 20 minutes.
Caution: The above interpreting time is based on room temperature range of
15-30℃. If your room temperature is
significantly lower than 15℃, then the interpreting time should be
properly increased to 30 minutes.
INTERPRETATION OF RESULTS
Positive: Two red lines are visible in the result window. The intensity of
the test line may be weaker or darker than that of the control
line. This still means a positive result.
Negative: The control line appears in the result window, but the test line
is not visible.
Invalid: If the control line does not appear in the result window, the test
results are INVALID regardless of the presence or absence of the
line in the test region.
