ELISA Kit For IgM Antibody To Hepatitis A And E Virus

INTENDED USE

ELISA Kit for IgM Antibody to Hepatitis A and E Virus is an in vitro enzyme immunoassay for the detection of Hepatitis A and E Virus -IgM in human serum or plasma.

Major Components

1. Antigen Coated Micro well Plate

2. Specimen Diluents

3. Conjugate HAV/HEV-Ag-HRP

4. Negative Control Serum

5. Positive Control Serum

6. 20 X Wash Buffer (dilution prior to use)

7. Substrate A

8. Substrate B

9. Stop Solution

10. Plastic Bag

11. Seal Paper

12. Manual

ASSAY PROCEDURE

1. Bring ELISA Kit for Antibody IgM to Hepatitis A and E Virus (all reagents), and samples to room temperature before use (approximately 30 minutes).

2. Dilute concentrated wash buffer 1:19 with ddH2O.

3. For each test, set one blank, two positive and three negative controls. Add 100μl positive and negative control serum into positive and negative control wells respectively.

4. Add 100μl diluted sample into other test wells.

5. Cover wells with seal paper, then incubate 30 minutes at 37°C.

6. Discard the liquid in all wells and fill the wells with wash solution. Lay aside for 15 seconds, discard the liquid in all wells and fill the wells with wash solution. Repeat 5 times and dry wells after last wash.

7. Add 100 μl Enzyme Conjugate in each well except the blank

8 .Cover wells with seal paper, then incubate 30 minutes at 37°C.

9. Repeat step 7.

10. Add 50 μl substrate A and B respectively to each well, mix gently protected from light and incubate 15 minutes at 37°C.

11. Add 50μl of stop solution into each well to stop the reaction, including blank well.

12. Measure the absorbance at 450 nm against the blank, or measure the absorbance at 450 nm/630-690 nm.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world