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INSTRUCTIONS FOR USE HBcAb ELISA For the detection of antibody to Hepatitis B C Antigen in human serum or plasma (in vitro)
INTENDED USE This HBcAb ELISA is a qualitative enzyme immunoassay for the in vitro detection of antibody to Hepatitis B C Antigen (HBcAg) 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 positive controls must be less than or equal to 0.1 and the mean OD value of negative controls must be greater than or equal to 0.8. 2. Cut off value = PC×0.6+NC×0.4 PC= the mean absorbance value for two positive controls NC= the mean absorbance value for two negative controls Important: If the NC is higher than 1.5, take it as 1.5. 3. OD value of the sample ≥ cut off value, it is negative for HBcAb; OD value of the sample < cut off value, it is positive for HBcAb. 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.