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Product Description
Solid-phase double-antibody sandwich ELISA for quantitative detection of residual bovine serum albumin (BSA). Microtiter strips are pre-coated with affinity-purified sheep anti-BSA capture antibody. Samples and calibration standards are incubated in the coated wells, followed by a biotinylated sheep anti-BSA detection antibody and streptavidin–HRP. TMB substrate is used for color development (blue product, max absorbance ~655 nm) and reaction is stopped to yield a yellow product read at 450 nm (with 620–650 nm reference). OD450 correlates with BSA concentration and sample results are calculated using a 4-parameter logistic (4-PL) calibration curve.
Technical Specifications
| Parameter | Details |
|---|---|
| Assay format | 96-well microtiter plate strips, double-antibody sandwich ELISA |
| Kit size | 96 tests/Kit (8-well × 12 strips) |
| Sample volume per well | 100 µL |
| Linearity & Range | 1–32 ng/mL (R² ≥ 0.990) |
| Lower Limit of Quantification (LLOQ) | 1 ng/mL |
| Specificity / Cross-reactivity | Cross-reactivity with host cell proteins (HEK293T, MDCK, CHO, BL21, Vero) < 0.1% |
| Calibration model / Example parameters | 4-parameter logistic (4-PL). Example: A=3.14274; B=-1.10808; C=36.73888; D=0.00859; R²=0.99999 |
| Read wavelength | Primary 450 nm, reference 620–650 nm |
| Recommended sample storage | For long-term storage, -70 °C or below recommended to avoid degradation; avoid repeated freeze-thaw cycles |
| Incubation examples | Sample incubation 2 h RT; biotinylated antibody 45 min RT; streptavidin-HRP 30 min RT; TMB reaction 15 min RT |
| Minimum recommended pipetting volume for dilutions | Minimum volume 5 µL recommended to avoid pipetting error |
Features
- High sensitivity: LLOQ 1 ng/mL enables detection of low-level residual BSA in bioprocess samples.
- High specificity: Sheep polyclonal anti-BSA capture/detection antibodies with cross-reactivity to common host cell proteins <0.1%.
- Ready-to-use pre-coated strips: Anti-BSA coated microtiter strips supplied in sealed bag with desiccant for reduced setup time and consistent performance.
- Validated 4-PL calibration: Use of 4-parameter logistic curve for accurate quantitation across the stated dynamic range.
- Complete reagent set: Includes calibration standard, wash buffer concentrate, biotinylated antibody, streptavidin-HRP, TMB substrate and stop solution.
- Optimized workflow: Standardized incubation and wash steps for reproducible results and straightforward integration into QC workflows.
Applications
- Quantitation of residual BSA in in-process samples
- Measurement of BSA in harvested bulk, drug substance and drug product
- Process development and purification monitoring in biologics manufacturing
- Quality control testing for residual serum-derived impurities
Kit Contents
BSA Calibration standard (PNB007)1 × 500 µL; store at 2-8 °C (refer to tube label); stable up to 1 year
Anti-BSA Microtiter Strips (PNA007)8-well × 12 strips; strips pre-coated, sealed in bag with desiccant; store at 2-8 °C, opened strips in bag with desiccant up to 30 days
Wash Buffer Concentrate (10×) (PNF001)2 × 25 mL; dilute 1:10 with ultra-pure water to prepare 1×Wash Buffer; store at 2-8 °C
Anti-BSA: Biotinylated Conjugate (100×) (PNG007)1 × 120 µL; biotinylated anti-BSA (sheep polyclonal) in protein matrix with preservative; sealed, keep away from light; dilute 100× in 1×Wash Buffer before use; centrifuge before use; recommended single-use, prepare fresh
Streptavidin-HRP (100×) (PNH002)1 × 140 µL; streptavidin labeled with HRP; sealed, keep away from light; dilute 100× in 1×Wash Buffer before use; centrifuge before use; recommended single-use, prepare fresh
TMB Substrate (PND005)1 × 12 mL; 3,3',5,5'-tetramethylbenzidine; sealed, keep away from light; equilibrate to RT 20 min before use; discard if colored
Stop Solution (PNI002)1 × 6 mL; 1 M HCl; store at 2-8 °C; handle with appropriate PPE (goggles, gloves)
Sealing Film (PNK001)3 pieces; use to cover strips during incubations to prevent evaporation
* Total: 96 tests/Kit | Method: ELISA (double-antibody sandwich)
Attention
• For Research Use Only (not for clinical use).
• Store the kit at 2-8 °C; check expiration dates on labels.
• Avoid BSA contamination of the workspace and consumables; perform assay in BSA-free environment.
• Do not mix reagents from different lot numbers.
• Use fresh ultra-pure water; water temperature should not exceed 37 °C.
• Avoid samples containing sodium azide (NaN3) because it inhibits HRP and will cause underestimation.
• Stop Solution is 1 M HCl — avoid direct contact with skin, eyes and clothing; wear goggles and appropriate PPE.
• Prepare Anti-BSA:Biotinylated Conjugate and Streptavidin-HRP fresh before use and centrifuge concentrates before dilution.
• TMB Substrate must be colorless before use; discard and contact support if colored.
• Do not allow wells to dry during the assay; seal plate to prevent evaporation after incubations.
• Plate reading should be completed within 30 minutes after stopping the reaction.
• Minimum recommended volume for accurate dilution steps is 5 µL; pipette carefully to avoid bubbles.
• Recommended to validate the method for each sample matrix prior to routine testing.
Quality Management & Certifications
Quality System
Download QMSQMS (ISO, GMP)
Download CertificateQuality Advantages
View ReportQuality Control Process
Download ProcessTechnical Resources & Downloads
Frequently Asked Questions (FAQ)
Q1: What is the assay dynamic range and LLOQ?
The assay linear range is 1–32 ng/mL with an LLOQ of 1 ng/mL.
Q2: How is sample concentration calculated?
Subtract NCS OD from sample OD, use a 4-parameter logistic (4-PL) regression of the calibration standards to derive concentration, then multiply by sample dilution factor.
Q3: How should I store opened components and prepared reagents?
Store unopened kit at 2–8 °C. Opened strips: keep sealed with desiccant at 2–8 °C up to 30 days. Calibration standard: 2–8 °C up to 1 year. Prepare diluted detection reagents fresh and use immediately; biotinylated antibody and streptavidin-HRP are recommended single-use due to stability.
Q4: Can I use this kit with different sample matrices (process intermediates, final drug product)?
Yes — the kit is intended for in-process samples, harvested bulk, drug substance and drug product. A method validation is recommended for each matrix to confirm suitability, appropriate dilutions, and recovery.
Research Use Only
✔
Research Use Only (RUO) – This product is intended for laboratory research purposes only and not for clinical or regulatory diagnostic use.
✔
Not intended for use in USDA or FDA regulated diagnostic testing or official compliance testing.
When can I expect my order to ship?
Most orders are filled and shipped within 2-3 business days from the time they are received.
Our standard shipping usually take 2-5 days.
We also provide express shippping for time-sensitive deliveries.
Email contact@biofargo.com if you have any requirements.
