infectious diseases viruses Hepatitis B virus HBsAb ELISA test Kit

Specifications 1.Used for diagnosis of HBV infection

2.diagnostic test

INTENDED USE
This HBsAb ELISA is a qualitative enzyme immunoassay for the in vitro detection of antibody to Hepatitis B
Surface Antigen (HBsAb) in human serum or plasma. It is intended to use in medical laboratories for diagnosis
and management of patients related to infection with hepatitis B virus.
COMPONENTS
1. Microplate 96 wells
2. Negative Control 1 mL ×1
3. Positive Control 1 mL ×1
4. Conjugate 6 mL ×1
5. Washing Buffer (20×) 20 mL ×1
6. Substrate Solution A 6 mL ×1
7. Substrate Solution B 6 mL ×1
8. Stop Solution 6 mL ×1
9. Plate Cover 2 pieces
10. Insert 1 copy
ASSAY PROCEDURE
1. Prepare Reagents: Dilute 1 volume of Concentrated Washing Buffer (20×)with 19 volumes of distilled water,
mix well.
2. Add Samples and Conjugate: Open the foil pouch and remove the Microplate. Set up 1 well as Blank, 2 wells
as negative control, 2 wells as positive control. After dispensing 50μL Samples and 50μL Negative Control or
Positive Control to the respective wells, add 50μl of Conjugate into each well except the blank. Gently
vibrating the plate.
3. 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.
4. Wash the Plate: Remove the plate cover. Aspirate the contents of all wells. Fill the wells with the diluted
washing buffer ( 10~20 seconds to soak) then aspirate again. Repeat the procedure for 5 times. Make sure
that the rest volume is minimal, by tapping plate onto absorbent paper.
5. Add Substrate: Add 50μL of Substrate Solution A and 50μL of Substrate Solution B to each well, mix well.
Cover and incubate at 37℃ for 10 minutes.
6. Stop reaction: Add 50μL Stop Solution to each well, mix well.
7. Read the absorbance at 450 nm. If a dual wavelength measurement is used, the reference wavelength should
be selected from 620nm to 690nm.
RESULTS
1. For the assay to be valid, the mean OD value of negative controls must be less than or equal to 0.1 and the
mean OD value of positive controls must be greater than or equal to 0.8.
2. Cut off value = 2.1×NC
NC= the mean absorbance value for two negative controls
Important: If the NC is lower than 0.05, take it as 0.05.
3. OD value of the sample ³ cut off value, it is positive for HBsAb.
OD value of the sample < cut off value, it is negative for HBsAb.
PRECAUTIONS
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.