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| Product Name | Streptavidin Magnetic Beads for Chemiluminescence |
| Catalog No. | MAGBEA-0017 |
| Description | High-performance streptavidin-conjugated superparamagnetic beads specifically optimized for chemiluminescence immunoassay (CLIA) platforms. The beads feature an engineered surface chemistry with extremely low non-specific binding characteristics, high-density oriented streptavidin coupling, and defined particle size distribution for consistent fluidic handling and optical detection. Each production lot is validated for signal-to-noise ratio, within-lot precision, and lot-to-lot consistency using a standardized CLIA protocol. |
| Intended Use | Solid-phase capture support for biotinylated antibodies, antigens, and nucleic acid probes in automated chemiluminescence immunoassay analyzers, bead-based multiplex immunoassay systems, and high-sensitivity diagnostic platform development. |
| Principle / Technology | Recombinant streptavidin is covalently coupled at high density to 3 µm superparamagnetic polymer beads through a multi-point oriented linkage chemistry. The bead surface incorporates a non-fouling polymer layer that reduces non-specific protein adsorption to background levels. Biotinylated capture molecules bind essentially irreversibly (Kd ~10^-15 M). In CLIA format, the bead-captured immune complexes are magnetically concentrated, washed, and reacted with chemiluminescent substrate, generating a signal proportional to analyte concentration. The enhanced magnetite loading ensures rapid magnetic capture on automated platforms. |
| Detection Method | DLS and Coulter counter for size; streptavidin loading by BCA; biotin binding by HABA and biotin-HRP; chemiluminescence testing with model sandwich immunoassay; signal-to-noise ratio (S/N); calibration curve linearity; intra- and inter-lot CV on automated CLIA platform; accelerated stability study |
| Sample Type | Biotinylated monoclonal and polyclonal antibodies, biotinylated antigens, biotinylated oligonucleotide probes, biotinylated hapten-BSA conjugates for competitive immunoassay; optimized for sandwich and competitive CLIA formats |
| Performance Range / Specifications | Bead diameter: 3.0 ± 0.3 µm (CV <8%); streptavidin loading: 10-25 µg/mg; biotin binding: 500-1500 pmol/mg; biotin-IgG binding: 10-30 µg/mg; non-specific binding: <0.5 µg BSA/mg; S/N in model CLIA: >500; within-lot precision: CV <5%; lot-to-lot CV: <10%; magnetic separation: <3 seconds; bead recovery after CLIA cycle: >95% |
| Sensitivity / LOD | Sensitivity in CLIA format: <0.1 pg/mL for optimized sandwich immunoassay; linear range spanning 3-4 orders of magnitude; minimal hook effect at high analyte concentrations; consistent signal across assay replicates (CV <5%) |
| Specificity | Streptavidin-biotin interaction provides near-irreversible capture; no cross-reactivity with common serum components; no binding of non-biotinylated detection antibodies; low cross-lot signal variation; non-fouling surface eliminates matrix effects from serum, plasma, and other biological samples; minimal interference from bilirubin, hemoglobin, lipids, and rheumatoid factor |
| Reaction Conditions / Protocol | For automated CLIA: dispense 10-50 µg beads per test; add biotinylated capture antibody (pre-coupled or co-incubated with sample); incubate with sample containing analyte; wash beads magnetically; add detection antibody (enzyme-labeled); wash; add chemiluminescent substrate (e.g., acridinium ester, isoluminol, or ALP-AMPPD); measure luminescence; total assay time: 15-45 minutes depending on platform and incubation conditions; pre-coupling of biotinylated antibody to beads recommended for assay consistency |
| Components / Formulation | Streptavidin-coated superparamagnetic beads, 3.0 µm, 10 mg/mL in PBS pH 7.4 with 0.02% sodium azide and 0.1% BSA stabilizer; supplied as ready-to-use suspension for CLIA platform integration; BSA stabilizer verified biotin-free |
| Storage Conditions | 2-8°C; do not freeze; protect from light; gentle agitation recommended during long-term storage to prevent settling; use within 24 hours after dilution to working concentration |
| Shelf Life | 18 months at 2-8°C; streptavidin activity >85% through expiry; CLIA performance maintained; no increase in non-specific binding; preservative efficacy verified; opened: 6 months with aseptic technique |
| Package Specifications | 1 mL, 5 mL, 10 mL, 50 mL, 100 mL, 500 mL at 10 mg/mL; bulk OEM supply (liters); custom concentrations and packaging; supplied in detergent-free buffer for CLIA compatibility; ready-to-dispense bottles for automated filling lines |
| Product Form | Uniform dark brown to black suspension; highly homogeneous after gentle mixing; no foaming (detergent-free); rapid magnetic capture in automated platform magnet station; consistent bead dispensing by automated liquid handlers; uniform particle population by microscopy |
| Quality Control | Per lot: streptavidin loading, biotin binding capacity, CLIA performance (S/N, calibration curve linearity, intra-assay CV <5% across 20 replicates, inter-assay CV <8% across 5 runs), non-specific binding, bead recovery, endotoxin (<0.05 EU/mg), bioburden, particle size distribution; accelerated stability study (37°C, 30 days); real-time stability monitoring program |
| Key Features | Engineered for automated CLIA platforms; ultra-low non-specific binding surface; high S/N ratio for sensitive detection; tight particle size distribution for consistent fluidics; rapid magnetic separation for high-throughput; validated lot-to-lot consistency for IVD manufacturing; comprehensive QC documentation and DMF support available |
| Purity | Streptavidin >95%; no free biotin; endotoxin <0.05 EU/mg; host cell protein <50 ppm; preservative metered; detergent-free; CLIA-validated low background |
| Concentration | 10 mg/mL; streptavidin 10-25 µg/mg; biotin binding 500-1500 pmol/mg; particle count approximately 10^9 particles per mL at 10 mg/mL |
| Activity / Unit Definition | Biotin binding: 500-1500 pmol/mg; biotin-IgG: 10-30 µg/mg; CLIA S/N >500; intra-assay CV <5%; inter-assay CV <8%; activity >85% at 18 months |
| Molecular Weight | Streptavidin tetramer: ~53 kDa; bead molecular weight ~10^11-10^12 g/mol (polymer-magnetite composite) |
| Source / Origin | Recombinant streptavidin (E. coli); synthetic polymer-magnetite beads with proprietary non-fouling surface coating; animal-origin-free; TSE/BSE free; all components traceable; manufactured in ISO Class 8 cleanroom |
| pH Range / Optimal pH | CLIA buffer compatibility: pH 6.0-9.0; streptavidin stable: pH 4-10; optimal biotin binding: pH 6.5-8.5; bead integrity: pH 2-13; common CLIA substrate pH: alkaline phosphatase-AMPPD pH 9.0-9.5 compatible post-capture |
| Shipping Conditions | Cold pack at 2-8°C; insulated validated shipper; temperature data logger available for bulk OEM shipments; do not freeze; expedited shipping recommended; non-hazardous |
| Expiration Date / Stability | 18 months at 2-8°C; real-time stability at 0, 3, 6, 9, 12, 18 months: CLIA performance, streptavidin activity, non-specific binding, bead recovery; accelerated 37°C/30-day data supports shelf life; after first use: 6 months |
| Regulatory / Compliance | For research use and IVD component manufacturing; DMF and technical file support; ISO 13485 manufacturing; change control process; quality agreement available; batch records retained; retain samples for each production lot; stability commitment per ICH Q1A guidelines |
| Compatibility | Compatible with acridinium ester, isoluminol, AMPPD (ALP), and HRP-luminol chemiluminescent substrates; compatible with serum, plasma, whole blood, urine, CSF matrices; compatible with Tecan, Hamilton, Beckman, Roche, Abbott, Siemens CLIA platform designs; surfactant-free for bubble-free dispensing; validated with biotinylated antibodies from all major commercial sources |
| Recommended Buffer System | Storage: PBS pH 7.4, 0.02% NaN3, 0.1% BSA (biotin-free); working dilution: PBS or TBS pH 7.4; blocking: 1% biotin-free BSA or casein in TBS; wash buffer for CLIA: TBS pH 7.4 with 0.05% Tween-20 (detergent-free option available); no interfering buffer components for common CLIA substrate systems |
| Application Notes / Precautions | Optimize bead quantity per test for desired dynamic range (typically 10-50 µg/test for sandwich CLIA); pre-wash beads to remove BSA stabilizer if coupling biotinylated antibody in situ; verify biotin-free status of all buffer components and blocking reagents; for long-term reagent stability, lyophilize antibody-coupled beads with trehalose/sucrose cryoprotectant; validate CLIA substrate compatibility—some substrates are sensitive to sodium azide; perform accelerated stability on coupled-bead reagents for product shelf-life determination |
| Batch-to-Batch Consistency | Streptavidin loading CV <10% inter-lot; biotin binding CV <8%; CLIA S/N consistent within ±15% of reference lot; particle size CV <8% inter-lot; intra-lot CV <5%; Cpk >1.67 for critical quality attributes; SPC monitoring of all manufacturing process parameters |
For research use only, not for clinical use.
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