Diagnostic kit for anti-HAV-HEV IgM (Colloidal Gold)

الوصف

PRODUCT DESCRIPTION
Intended Use:It is used for diagnostic of anti-HAV-HEV IgM from human serum(or plasma) and can be used clinically.
Diagnostic Principles:The anti-HAV-IgM kit depends on capture method and gold immunochromatography assay. The HAV antigen and mouse monoclonal antibody are coating in polyester fibre(or non-woven fibrics) and the test lines with nitrocellulose membrane and control lines are coated with human IgMµ chain monoclonal antibody and IgG antibody separately. When the positive samples are added, the IgM antibody of HAV virus in the serum of plasma can combined with the HAV-antigen in the colloidal gold. The compound can move forward due to the chromatography effect and form Au-HAV Ag-HAV anti-human IgM Ab with pre-coated anti-human IgMµ chain monoclonal antibody when passing the testing lines. As a result, the lines turn to be amaranth. In the control lines, the free gold standard mouse monoclonal antibody can attach to the anti-mouse IgG antibody and make the control lines amaranth. But in the negative group, the amaranth is only found in control lines.
When the positive samples are added, the IgM antibody of HEV virus in the serum of plasma can combined with the HAV-antigen in the colloidal gold. The compound can move forward due to the chromatography effect and form Au-HEV Ag-HEV anti-human IgM Ab with pre-coated anti-human IgMµ chain monoclonal antibody when passing the testing lines. As a result, the lines turn to be amaranth. In the control lines, the free gold standard mouse monoclonal antibody can attach to the anti-mouse IgG antibody and make the control lines amaranth. But in the negative group, the amaranth is only found in control lines.
Preserving Conditions and Period of Validity:It is protected from light and dry place and is without frozen. The period of validity is *4 months from production. It can be stored in *5% humidity for one hour after it is unsealed. It should be used immediately if the humidity is above *5%.
Sample Requirement:
1.      The venous blood should be sampled aseptically and separate the serum or plasma as soon as possible to avoid hemalysis.
2.      The fresh sample should be used. It can be stored in **8℃ for 7 days if the sample cannot be used immediately. It is be stored in **0℃ for long-time preservation and cannot be frozen more than 3 times.
3.      0.2mg/ml heparin, **0mmol/L EDTA*2Na and 2.5% sodium citrate do no effect on the test result.
4.      The sample should not used if it is hemolytic.
5.       0.1%NaN3 has no effect on the test result.
Testing Method:
  You should read the instruction thoroughly before using.
1.      Take the sample out to room temperature and number them.
2.      Dilute the serum or plasma 1:**0 with dilution (take 2 ul sample to **8ul dilution and mixed thoroughly).
3.      Take the card out from the box, open the aluminum foil and put the card on the table.
4.      Suction the diluted serum or plasma with suction tube and put 2 drops to the pore.
5.      Positive samples can be tested in ***5 minute