膜杰作
Star Staining
- Rapid - Results can be obtained within 90 minutes.
- Reference Standard Traceability - The reference standard is traceable to the National Standard NIFDC (cat # 140619)<<1225>>.
- Rigorous Method Validation - Validation reports compliant with ICH guidelines can be provided upon request.
- High Sensitivity - Sensitivity for Bovine Serum Albumin (BSA) is < 0.5 ng/mL.
- Strong Specificity - No cross-reactivity with non-target proteins.
- Excellent Buffer Compatibility - Compatible with a wide range of buffer systems.
产品描述（Product Details）
| Assay Type | Sandwich-ELISA |
| Analyte | BSA (Bovine serum albumin) |
| Format | 96T(8×12 strips) |
| Regulatory Status | RUO |
| Sensitivity | ＜0.5ng/mL |
| Standard Curve Range | 0.5ng/mL-40.5ng/mL |
| Assay Time | 1.5 hr |
| Suitable Sample Type | For the quantitative determination of BSA (Bovine serum albumin) |
| Sample volume | 50μL |
背景（Background）
Bovine serum is a key component in biological product manufacturing, with Bovine Serum Albumin (BSA) as its primary constituent. BSA is often introduced as a medium additive or process aid during production. However, as a heterologous protein, its presence poses significant risks to product safety and efficacy. Excessive BSA residues can trigger immunopathological reactions in humans or animals, leading to allergies, immunogenicity, or other severe side effects, compromising therapeutic outcomes. To mitigate these risks, global regulatory authorities mandate strict quality control measures to ensure BSA residues are minimized to acceptable levels. This includes optimizing production processes, validating purification methods, and implementing sensitive analytical techniques for residual detection. Such controls are critical to ensuring the safety, efficacy, and compliance of biological products.
应用说明（Application）
The kit is developed for the detection and quantitative determination of BSA. It is used as a tool to aid in optimal purification process development and in routine quality control of in-process streams as well as final product by various biotechnological processes such as cell or tissue culture .The standard BSA has been calibrated against NIFDC standard (cat # 140619) for accurate assay result.
It is for research use only.
存储（Storage）
1. Unopened kit should be stored at 2℃-8℃ upon receiving.
2. Find the expiration date on the outside packaging and do not use reagents past their expiration date.
3. The opened kit should be stored per components table. The shelf life is 30 days from the date of opening.
组分（Materials Provided）
| ID | Components | Size |
| RES01-C01 | Pre-Coated Anti-BSA Antibody Microplate | 1 plate(8×12 strips) |
| RES01-C02A | BSA (Bovine serum albumin) Standard (200ng/mL) | 500 μL |
| RES01-C02B | BSA (Bovine serum albumin) Standard 5 (40.5ng/mL) | 500 μL |
| RES01-C02C | BSA (Bovine serum albumin) Standard 4 (13.5ng/mL) | 500 μL |
| RES01-C02D | BSA (Bovine serum albumin) Standard 3 (4.5ng/mL) | 500 μL |
| RES01-C02E | BSA (Bovine serum albumin) Standard 2 (1.5ng/mL) | 500 μL |
| RES01-C02F | BSA (Bovine serum albumin) Standard 1 (0.5ng/mL) | 500 μL |
| RES01-C02G | BSA (Bovine serum albumin) Standard 0 (0ng/mL) | 500 μL |
| RES01-C03 | HRP-Anti-BSA Antibody | 100 μL |
| RES01-C04 | 1×Sample Dilution Buffer | 50 mLX2 |
| RES01-C05 | 20×Washing Buffer | 25 mL |
| RES01-C06 | Substrate Solution | 12 mL |
| RES01-C07 | Stop Solution | 8 mL |
原理（Assay Principles）
The resDetect™ BSA ELISA Kit is used to measure the levels of BSA (Bovine serum albumin) by employing a standard sandwich-ELISA format. The micro-plate in the kit has been pre-coated with anti-BSA antibody. Firstly adding standards and samples, next add the HRP-Anti-BSA Antibody to the plate . At last, load the tetramethylbenzidine (TMB) substrate into the wells and monitor a blue color. The reaction is stopped by the addition of a stop solution and the color turns yellow. The intensity of the absorbance can be measured at 450nm and 630nm on a microtiter plate reader. The OD Value reflects the amount of BSA (Bovine serum albumin).
典型数据-Typical Data Please refer to DS document for the assay protocol.
Detection of BSA ( Bovine serum albumin) by ELISA Assay.
Immobilized Anti-BSA Antibody can bind BSA (Bovine serum albumin) Detection was performed using HRP-Anti- BSA Antibody with sensitivity of 0.5 ng/mL (QC tested). For each experiment, a standard curve needs to be set for each micro-plate, and the specific OD value may vary depending on different laboratories, testers, or equipments. The following example data is for reference only.
验证（Validation）
批内差异（Intra-Assay Statistics）
Three samples of known concentration were tested ten times on one plate to assess intra-assay precision , Intra-Assay Precision CV≤15%.
批间差异（Inter-Assay Statistics）
Three samples of known concentration were tested in ten separate assays to assess inter-assay precision, Inter-Assay Precision CV≤15%.
准确度（Accuracy）
Five samples of known concentration were tested ten times to assess Accuracy , Accuracy recovery rate 80-120%.
干扰效应(Interference effect)
We have conducted interference effect test about frequently-used buffers, they have excellent buffer compatibility. For specific buffers, it is recommended that you verify recovery to determine the minimum dilution ratio.
专属性（Specificity）
High, medium and low concentrations of BSA were added to Human serum (v/v 1%), Horse serum (v/v 10%) , Human Serum Albumin (1.25 mg/mL) and Rabbit serum (v/v 10%), the recovery rate of BSA was used as the specific validation index.
High, medium and low concentrations of BSA were added to MDCK( 2×106 cells/mL), HEK293( 3.5×106 cells/mL) , CHO( 2×106 cells/mL) and T-lymphocyte( 2.15×106 cells/mL) the recovery rate of BSA was used as the specific validation index.
