COVID-19 IgMIgG Antibody Rapid Test Kit
Intended Use:
The kit is used for the in vitro qualitative detection of novel coronavirus (SARS-CoV-2) IgM/IgG antibodies in human serum, plasma or whole blood samples. The kit can be used as a supplementary test index for suspected cases with a negative nucleic acid test for the novel coronavirus or used in conjunction with nucleic acid or antigen detection in the diagnosis of suspected cases.
The results of the kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical manifestations and other laboratory tests.
Storage Conditions and Shelf Life:
Stored in a dry place at 2-30 ℃ and the shelf life is 18 months.
Detection Principle:
The product adopts antibody capture method and solid phase immunochromatographic method for detection. The sample to be tested ( serum/ plasma/ whole blood ) is added to the sample hole and chromatographically. The novel coronavirus IgM/ IgG antibody in the sample react with the recombinant novel coronavirus (SARS-CoV-2) antigen colloidal gold conjugate to form a colloidal gold-labeled antigen-IgM complex and a colloidal gold-labeled antigen-IgG complex and free colloidal gold labeled chicken IgY.
Sample Requirements:
The applicable sample types for this kit are serum, plasma and whole blood.
1.The test is designed only for use with human serum, plasma, or whole blood samples for the qualitative detection of SARS-CoV-2 IgM and IgG antibody.
2.As in case of all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test but should rather be made after all the clinical findings have been evaluated and should be confirmed by other conventional detection methods, such as molecular diagnostics and CT.
3.A false negative may occur if the amount of SARS-CoV-2 IgM or IgG antibody is below the detection level of the kit.
4.If the test gets wet prior to use, or is stored improperly, it may cause incorrect results.
5.The test is for qualitative detection of SARS-CoV-2 IgM or IgG antibody in human serum, plasma, or blood samples, it does not indicate the quantity of the antibodies present.
6.Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
7.This test is intended for healthcare professional use and not for home use.
8.This test is not for the screening of donated blood.
