China Coronavirus Igmigg Rapid Diagnostic Test Antibody Combo Test Kit

Coronavirus is a large family that exists widely in nature. It is susceptible to humans and many animals. It is named for its corona-like fibroids on the virus particle surface . The typical clinical symptoms of the new coronavirus (2019-nCoV) infection are fever, fatigue, muscle soreness, and dry cough, which can progress to severe pneumonia, spiratory failure, and even life-threatening.

Product Name2019-nCov IgG/IgM antibody Test Kit(Colloidal gold Assay)Packing Size25T/kitSample Requirements1.Clinical human serum, plasma or whole blood samples (including
EDTA, heparin, sodium citrate anticoagulation).
2.Serum or plasma samples can be stored at 2-8ºCfor 7 days. If
long-term storage is required, samples should be stored at -20ºC to
avoid repeatedly freezing and thawing.
3.Whole blood samples can be stored at 2-8ºC for 7 days, and should
not be stored frozen.

If whole blood test, sealed pouches each containing a test kit, a 4 μL mini plastic dropper and a desiccant
1 Buffer
1 package insert
If serum/plasma test,sealed pouches each containing a test kit and a desiccant
1 Buffer
1 package insert
Test method:
The interpretation methods are as follows:

M line G line C Line result- - √Negative√ - √ IgM positive
IgG Negative- √ √ IgG Positive
IgM Negative√ √ √ IgG Positive
IgM Positive√ - - Invalid test. Test again- √ - Invalid test. Test again√ √ - Invalid test. Test again- - - Invalid test. Test again

Notices
Novel coronavirus IgM/IgG antibody was not detected by negative results, but if the amount of the new coronavirus IgM/IgG antibody
in the sample was lower than the minimum detection limit of the kit, negative results could also be obtained.
1.Use fresh samples whenever possible. Frozen and thawed samples (especially repeatedly) contain particles that can
block the membrane. This slows the flow of reagents and can lead to high background color, making the interpretation of
results difficult.
2.Optimal assay performance requires strict adherence to the assay procedure described in this insert sheet. Deviations
may lead to aberrant results.
3.A negative result for an individual subject indicates absence of detectable anti-COVID-19 antibodies. However, a
negative test result does not preclude the possibility of exposure to or infection with COVID-19.
4.A negative result can occur if the quantity of the anti-COVID-19 antibodies present in the specimen is below thedetection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a
sample is collected.
5.Some specimens containing unusually high titer of heterophile antibodies or rheumatoid factor may affect expected
results.
6.As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should
only be made by the physician after all clinical and laboratory findings have been evaluated.
Relative Sensitivity: 91.8%, Relative Specificity: 96.4%, Overall Agreement: 95.0%