Certificate of Analysis
Contents
1. ar i 9 gt BioChain www biochain com Tel 1 888 762 2568 Fax 1 510 783 5386 Email info biochain com User s Manual and Instructions ELISA Kit for Antibody to Hepatitis B Surface Antigen Catalog No KO31004096 INTENDED USE ELISA Kit for Antibody to Hepatitis B Surface Antigen is an in vitro enzyme immunoassay for the detection of Anti HBs in human serum or plasma PRINCIPLE The purified HBsAg is coated on the solid phase of multi wells Serum sample and Horseradish peroxidase labeled with HBsAg conjugated are added to coated wells After incubation if Anti HBs is present in the sample a complex of HBsAg Anti HBs HBsAg labeled with HRP will form Wash wells to remove other unbounded serum components incubate with substrates TMB to form a colored product and measure the absorbance at 450nm to indicate the presence or absence of Anti HBs in the sample The test is special sensitive reproducible and easy to operate STORAGE AND STABILITY Store the kit at 2 8 C The kit is stable unopened within 12 months after it is received MATERIALS PROVIDED 1 HBsAg Coated Microwell Plate 2 Enzyme Conjugant 1 bottle 6 5m 3 Positive Control Serum 1 vial 1 0ml 4 Negative Control Serum 1 vial 1 0ml 5 Wash Buffer 1 20 dilution prior to use 1 bottle SOml 6 Substrate A 1 bottle 8 5ml 7 Substrate B 1 bottle 8 5ml 8 Stop Solution 1 bottle 8 5ml 9 Seal Paper 2 pieces PRECAUTIONS 1 The sampl2. 0 60 minutes at 37 C 2 Manual Wash Procedure Discard the liquid in the coated wells and bring them to dry Fill the wells with 300ul wash buffer discard the liquid Repeat 5 times and then bring them to dry Automatic Wash Procedure Select the automatic operations of washing 5 times and bring them to dry after the operation 3 Add one drop approximately 0 05ml of substrate A and B respectively to each well seal the plate with seal paper mix thoroughly and incubate for 10 15 minutes at 37 C Avoid exposure to light 4 Add one drop approximately 0 05ml of stop solution into each well mix thoroughly to terminate the reaction Measure the absorbance at 450nm against the blank or measure the absorbance at 450nm 630 690 nm INTERPRETATION OF RESULTS Colorimetric Method Cut Off Value calculation COV the average OD of negative controls x 2 1 Positive OD s5 0 of sample gt COV Negative OD 5 0 of sample lt COV Invalid If the OD of positive control is lt 1 0 or negative control is 2 0 1 the result is invalid In any event repeat the test If the problem persists contact the local distributor Notes If the absorbance of negative controls is below 0 05 calculate it as 0 05 If the absorbance of negative controls is above 0 05 calculate it as its original value PERFORMANCE CHARACTERISTICS Sensitivity 10mlU ml OD 20 105 Specificity the average OD of 20 normal negative samples lt 0 030 Precision CV lt 15 n
3. 10 This Kit is for Research Use Only Active Date 05132015
4. es should be fresh and avoid hemolysis bacterial growth and repetitive freeze thaw cycle 2 Do not interchange reagents between different lots 3 The seal paper CANNOT be used repeatedly 4 Mix reagents well before use If crystal form in certain reagents such as wash buffer warm bottle vials to redissolve Mix well 5 Follow the instruction provided in the manual especially for incubation temperature and reaction time All pipetting devices should be used with care and calibrated regularly following the manufacturer s instructions 6 Put the remaining reagents in the sealed pouch and return them to 2 8 C for short period of storage 7 To prevent cross contamination wear gloves and lab coats throughout the procedure and disinfection spills immediately Dispose of all samples and materials used to perform the test To disinfect used samples and materials before disposal one should autoclave at 121 C or use 5 0 g L liquid sodium hypochlorite solution The positive control serum in the kit has been inactivated already F 753 3UMRevA 1 block 96wells KO31004096UB ASSAY PROCEDURE 1 For each test set one blank two positive and two negative controls add 0 05ml serum sample positive and negative control serum into the coated wells then add one drop approximately 0 05ml of enzyme conjugant into the same coated wells The blank well is omitted mix thoroughly cover wells with seal paper and incubate for 3
Download Pdf Manuals
Related Search