#COVID
Science of Antibody Testing Immunochromatography, PRODUCT NAME
Generic name: COVID-19 IgM and IgG Dual Antibody Rapid Test Kit (Colloidal Gold
Method).
• PRODUCT SPECIFICATIONS
20 tests/box
• EXPECTED USAGE
This kit is suitable for the qualitative detection of novel coronavirus (SARS-CoV-2) IgM and
IgG antibodies in human serum and whole blood. Common signs of a person infected with a
coronavirus include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In
more severe cases, infection can cause pneumonia, severe acute respiratory syndrome (SARS),
kidney failure, and even death. Coronavirus can be excreted through respiratory secretions or
transmitted through oral fluids, sneezing, physical contact, and through air droplets.
• DETECTION PRINCIPLES
The detection kit uses the principle of immunochromatography: the separation of components
in a mixture through a medium using capillary force and the specific and rapid binding of an
antibody to its antigen. Each cassette is a dry medium that has been coated separately with
novel coronavirus N protein (“T” test line) and anti-mouse antibody (“C” control line) (Figure
1). The cassette contains two separate strips and sample pads, one for detection of IgM
antibodies, and the other for detection of IgG antibodies. Free colloidal gold-labeled antihuman IgM and IgG are in the release pad section (S). Once diluted serum or whole blood is
applied to the release pad section, the anti-human IgM and IgG antibodies will bind to
coronavirus IgM and IgG antibodies if they are present, forming an Ig-IgM or Ig-IgG complex.
The sample and antibodies will then move across the cassette’s medium via capillary action. If
coronavirus IgM or IgG antibodies are present in the sample, the test line (T) will be bound by
the Ig-IgM or Ig-IgG complex and develop color. If there is no coronavirus IgM or IgG
antibodies in the sample, free anti-human IgM or free anti-human IgG will not bind to the test
line (T) and no color will develop. The free anti-human IgM or free anti human IgG antibodies
will bind to the control lines (C); these control lines should be visible after the detection step
as this confirms that the kit is working properly
Confirmation of Positive Reference samples per batch: 3 individual positive references samples
were tested, and the result should identify all as positive samples. Results found 3 of 3 to be a
positive and valid result.
b. Confirmation of Negative Reference samples per batch: 20 negative reference samples and
products were tested, and the results should find all samples as negative. Results found 20 of
20 samples to show a negative and valid result.
c. Minimum detection limit: 3 samples at different concentrations of antibodies were tested,
whereby a correct dilution (L3) and a lower dilution (L2) should be positive, while a too far
diluted sample (L1), should be negative. Results confirmed L3, and L2 as positive, while L1
was negative.
d. Repeatability: 10 Detection Cassettes for the sample positive sample across 2 different lots of
Detection Cassettes were probed simultaneously. All 10 showed a positive and valid result.
e. The sensitivity of IgM and IgG tests combined against reference standard in overall study
population is 90.44% (123/136, 95%CI: 84.21-94.81%).
f. The specificity of IgM and IgG tests combined against reference standard in overall study
population is 98.31% (1044/1062, 95%CI: 97.33-98.99%).
g. The accuracy of IgM and IgG tests combined against reference standard in overall study
population is 97.41% (1167/1198, 95%CI: 96.35-98.24%), with Kappa value of 0.873.
• PRECAUTIONS
a. This test has not been reviewed by the FDA.
b. This product is for in vitro diagnostic use only following FDA guidance “Policy for Diagnostic
Tests for Coronavirus Disease-2019 during the Public Health Emergency”.
c. The assay should be performed as outlined in this manual, and in accordance with all
instructions.
d. Do not use expired or damaged products.
e. Only use the matching diluent in the kit package. Diluents from different kit lots cannot be
mixed.
f. Do not use tap water, purified water or distilled water as negative controls.
g. The test should be used within 1 hour after opening. If the ambient temperature is higher than
30°C, or the test environment is humid, the Detection Cassette should be used immediately.
h. If there is no movement of the liquid after 30 seconds of beginning the test, 1 additional drop
of sample solution should be added.
i. Take care to prevent the possibility of virus infection when collecting samples. Wear disposable
gloves, masks, etc., and wash your hands afterwards.
j. This test card is designed for a single, one-time use. After use, the test card and samples should
be regarded as medical waste with risk of biological infection and properly disposed of in
accordance with national regulations.