Detection Method
Indirect-ELISA
Intended Use
The Human anti-BSA Ig ELISA Kit is an im munoassay suitable for quantifying or titering total antibody activity specific for bovine serum albumin (BSA) in serum or plasma. Other biological fluids, including tissue culture medium, may be validated for use.
Contents of Kit
| No. | Components | Size | Storage Conditions |
| 1 | BSA Microwell Strip Plate | 8-well strips (12) | 2-8°C |
| 2 | Anti-BSA Calibrators | 10 U/ml, 25 U/ml, 50 U/ml, 100 U/ml, 0.65 ml/vial | 2-8°C |
| 3 | Sample Diluent Concentrate (20×) | 10 ml | 2-8°C |
| 4 | Anti-Human Ig- HRP Conjugate Concentrate (100×) | 0.15ml | 2-8°C |
| 5 | Wash Solution Concentrate (100×) | 10 ml | 2-8°C |
| 6 | TMB Substrate | 12 ml | 2-8°C |
| 7 | Stop Solution | 12 ml | 2-8°C |
Storage
The microtiter well plate and all other reagents, if unopened, are stable at 2-8°C until the expiration date printed on the box label. Stabilities of the working solutions are indicated under Reagent Preparation.
Sensitivity
The BSA coating level and HRP conjugate concentration are optimized to differentiate anti-BSA Ig from background (nonantibody) signal with human serum samples diluted 1:200.
General Description
Bovine serum albumin (BSA) is the major protein of bovine serum (also fetal calf serum), used as a required nutrient for the in vitro culture of many cell types, including cell lines for production of recombinant proteins used as pharmaceutical drugs. Such recombinant protein culture products are purified from culture medium components, including BSA, which even as minor contaminants may affect drug efficacy and side effects. BSA is also highly immunogenic in mammals and can, therefore, elicit anti-BSA antibodies in the host receiving the BSA-contaminated drug. The measurement of residual culture components such as BSA and the immunological host response, i.e., anti-BSA antibodies, is a requirement of the manufacturing processes of recombinant protein drug production.
Purified BSA is also used as a carrier protein for chemical attachment of small molecules, including peptides and other haptens, to produce an effective vaccine for production of antibodies specific for the attached molecule. The BSA-hapten immunization effectively produces anti-BSA antibodies concomitant with anti-hapten antibodies. These ‘by-stander’ antibodies, which may interfere with the subsequent use and interpretation of the anti-hapten activity, are commonly removed by solid phase BSA adsorbents.
The Creative Diagnostics Human Anti-BSA IgG ELISA is a sensitive and convenient method for detecting and quantifying anti-BSA IgG antibodies arising from BSA contamination of administered drugs, and for following anti-BSA antibodies from carrier-hapten immunizations.
Citations
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