Diagnostic Kit (Colloidal Gold) for IgM/IgG Antibody to Dengue Virus
For in vitro diagnostic use only
Please read this package insert carefully prior to use and strictly follow the instructions. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.

INTENDED USE

Diagnostic Kit（Colloidal Gold）for IgM/IgG Antibody to Dengue Virus is a colloidal gold immunochromatographic assay for the qualitative detection of IgM/IgG Antibody to Dengue Virus in human serum and plasma. This test is a screening reagent. All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only.

PACKAGE SIZE
Twenty-five serving.

SUMMARY
Dengue Fever (Dengue Fever) is caused by Dengue virus infection. Dengue Fever is a group B vector virus and the yellow virus family flavivirus. Dengue virus antibody tests are often used enzyme-linked Immunoassay, Indirect Immunofluorescent Assay, Immunochromato – graphic Test. In recent years, with the development of the immune colloidal gold chromatography technology, using colloidal gold immune chromatography to detect serum (plasma) dengue virus antibody has become a reality. This method is characterized by simple operation, quick detection speed and saving manpower and material resources. It makes up for the inconveniences of ELISA and chemiluminescence method.

ASSAY PROCEDURE
1.Take out the test card from the foil bag, put it on the level table and mark it.
2.Use pipette to absorb sample 2ul, add it into sample well of the card;
3.Add 2 drops (80-100ul) sample diluent into sample well of the card;
4.The result should be read within 20 minutes.

TEST RESULTS AND INTERPRETATION[2]

	Test results and interpretation
	IgM/IgG positive: The magenta stripe appear in quality control line (C) , test line G and test line M, indicating that the sample contains dengue virus IgM/IgG antibody.
	IgG positive: The magenta stripe appear in quality control line (C) and test line G, indicating that the samples contain dengue virus IgG antibodies.
	IgM positive: The magenta stripe appear in quality control line (C) and test line M, indicating that the sample contains dengue virus IgM antibody.
	Negative: The magenta strip only appear in quality control line (C), test line G and test line M have no magenta stripe, indicating that the samples do not contain dengue virus IgM/IgG antibody or dengue virus IgM/IgG antibody in sample is below the detection level of the reagent.
Invalid: The magenta strip does not appear in quality control line (C), indicating improper operation or reagent failure, should be retested.