For the detection of IgG antibody to Hepatitis E Virus
in human serum or plasma (in vitro)
This Anti-HEV IgG is a qualitative microplatechemiluminescence assay for the in vitro detection of IgG antibody to Hepatitis E Virus in human serum or plasma. It is intended for diagnosing patients related to infection with HEV.
1. Microplate96 wells
2. Standard 1 mL ×1
3. Negative Control1 mL ×1
4. Positive Control1 mL ×1
5. Sample Diluent12 mL ×1
6. Conjugate12 mL ×1
7. Washing Buffer (20×)50 mL ×1
8. Substrate Solution A6 mL ×1
9. Substrate Solution B6 mL ×1
1. Plate Cover3 pieces
10. Insert1 copy
2. Prepare Reagents: Dilute 1 volume of Concentrated Washing Buffer (20×)with 19 volumes of distilled water, mix well.
3. Add Samples: Open the foil pouch and remove the Microplate. Set up 1 well as Blank, 2 wells as standard, 1 well as negative control, 1 well as positive control. After dispensing 100μL of standard or sample Diluent , dispense 10μL of sample or negative control or positive control to the sample Diluent well. Gently vibrating the plate.
4. Incubate: Cover the Microplate with plate cover and incubate the Microplate in a thermostat-controlled water-bath or microplate incubator at 37℃ for 30 minutes.
5. Wash: Wash the Microplate for 5 times. Fill the wells with above 350μL of the diluted Washing Buffer, Soak for above 30 seconds, then aspirate again for each time. Make sure that the rest volume is minimal by tapping plate at absorbent paper.
6. Add Conjugate: Add 100μL of conjugate to each well (except for the blank well).
7. Incubate: Cover the Microplate and incubate the plate at 37℃ for 30 minutes.
8. Wash the Plate: Repeat the wash procedure as in step 4.
9. Add Substrate: Add 50μL of Substrate Solution A and 50μL of Substrate Solution B to each well, Vibrate the Microplate. Cover and incubate the Microplate in the dark at room temperature(18-24℃) for 5-10 minutes.
10. Read the RLU value by a microplate chemiluminescence immunoassay analyzer.
1. Cut off value = the mean RLU of Standards× 2.1
2. For the assay to be valid, the mean RLU value of Positive Controls must be greater than the Cutoff value.
3. RLU value of the sample ³ cut off value, it is positive for anti-HEV IgG.
RLU value of the sample < cut off value, it is negative for anti-HEV IgG..
1. Allow all kit components to reach room temperature before use.
2. Follow the direction insert to control the reaction temperature and time strictly.
3. Do not mix components of different lot numbers to use.
4. The kit should be store at 2-8℃. Do not use kit components beyond their expiration date.