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| Product Name | Carboxyl Magnetic Beads for Immunoassay (Superparamagnetic) |
| Catalog No. | MAGBEA-0019 |
| Description | Ultra-uniform carboxyl-functionalized superparamagnetic beads with a particle diameter of 1.5 µm, engineered specifically for high-performance chemiluminescence and fluorescence immunoassay platforms. The monodisperse size distribution (CV <5%) ensures consistent bead handling in automated dispensing systems and reproducible optical detection. The high-density carboxyl surface, combined with an optimized non-fouling polymer layer, supports efficient covalent antibody coupling via EDC/NHS chemistry while maintaining exceptionally low non-specific binding critical for high-sensitivity diagnostic assays. |
| Intended Use | Solid-phase support for covalent immobilization of capture antibodies and antigens in automated chemiluminescence immunoassay (CLIA) analyzers, bead-based ELISA, multiplexed immunoassay panels, and high-sensitivity biomarker detection platforms requiring excellent lot-to-lot reproducibility. |
| Principle / Technology | Uniform 1.5 µm polymer-magnetite beads are synthesized by controlled polymerization to achieve a monodisperse population. The surface presents high-density carboxylic acid groups on a non-fouling polymer interface that reduces non-specific protein adsorption to sub-microgram levels. Antibody coupling proceeds through standard EDC/sulfo-NHS activation in MES buffer at pH 5.0-6.0, followed by amide bond formation in PBS or borate buffer at pH 7.4-8.5. The high magnetite content (25-35% by weight) ensures ultra-rapid magnetic separation within 5 seconds, ideal for high-throughput automated systems. |
| Detection Method | Coulter counter and SEM for particle size uniformity; conductometric titration for carboxyl density; BCA and UV280 for antibody coupling efficiency; ELISA/CLIA testing for assay performance (sensitivity, dynamic range, precision); zeta potential for surface charge; TGA for magnetite content; automated liquid handler compatibility testing |
| Sample Type | Monoclonal and polyclonal antibodies (IgG, IgM), recombinant antigens, streptavidin, and other amine-containing proteins and peptides for covalent immobilization; carboxyl groups can also be used for amine-modified oligonucleotide coupling; designed for sandwich, competitive, and indirect immunoassay formats |
| Performance Range / Specifications | Particle diameter: 1.5 ± 0.05 µm (CV <5%); carboxyl density: 0.6-1.5 mmol/g (300-600 µeq/g); IgG coupling: 100-250 µg/mg beads; non-specific binding: <0.5 µg BSA/mg; magnetite content: 25-35% (TGA); magnetic separation: <5 seconds; sedimentation: minimal within 5 minutes of 1 mg/mL suspension; immunoassay sensitivity: <1 pg/mL for optimized sandwich CLIA; within-lot CV: <3%; lot-to-lot CV: <8% |
| Sensitivity / LOD | Antibody coupling detectable at 0.1 mg/mL input; CLIA signal linear across 4-log concentration range; sub-picogram detection limits achievable for optimized immunoassay; bead dispensing CV <2% for automated liquid handlers |
| Specificity | Covalent coupling specific for primary amines; no non-specific antibody adsorption on uncoupled, blocked beads; minimal cross-reactivity between coupled antibodies and non-target analytes; no interference from common serum matrix components (bilirubin up to 20 mg/dL, hemoglobin up to 500 mg/dL, lipids up to 1000 mg/dL triglycerides); no hook effect in sandwich assay up to 10⁶× LOD |
| Reaction Conditions / Protocol | Wash beads with MES activation buffer (50 mM MES pH 5.5); add EDC (10-50 mM) and sulfo-NHS (10-50 mM) freshly prepared in MES; incubate 15-30 minutes at room temperature with rotation; wash twice with cold coupling buffer (PBS pH 7.4 or borate pH 8.5); add protein at 50-200 µg/mg in coupling buffer; incubate 2 hours at room temperature or overnight at 4°C; wash; quench with 50 mM ethanolamine pH 8.0 for 30 minutes; wash extensively; resuspend in storage buffer; coupled beads ready for immunoassay use; total coupling: 4-6 hours; validated for scale-up to gram quantities |
| Components / Formulation | Carboxyl-functionalized superparamagnetic polymer beads, 1.5 µm, 10-50 mg/mL in deionized water with 0.02% sodium azide or ProClin preservative; detergent-free for CLIA compatibility; EDC and NHS reagents not included |
| Storage Conditions | 2-8°C; do not freeze; protect from light; store upright; vortex before each use; avoid contamination; for long-term storage, slurry format in water or phosphate buffer with azide or ProClin preservative |
| Shelf Life | 24 months at 2-8°C; carboxyl stability >90% at 24 months; particle size distribution stable; magnetic properties unchanged; preservative effective; opened: 12 months with aseptic handling |
| Package Specifications | 1 mL, 5 mL, 10 mL, 50 mL, 100 mL, 500 mL, 1 L at 10-50 mg/mL; bulk OEM supply; custom concentrations; ready-to-dispense bottles for automated production lines; lot reservation program available |
| Product Form | Dark brown to black uniform suspension; homogeneous after gentle vortexing; no foaming (detergent-free); smooth, uniform spherical particles by SEM; consistent lot-to-lot appearance; narrow size distribution visible by microscopy |
| Quality Control | Per lot: particle size CV (<5%), carboxyl density, IgG coupling capacity, non-specific binding, magnetite content, CLIA performance validation (model sandwich assay: sensitivity, dynamic range, intra-assay CV, inter-assay CV), endotoxin (<0.05 EU/mg), sterility, heavy metals, bioburden; accelerated stability (37°C, 30 days); real-time stability program; all QC data documented in lot-specific certificate |
| Key Features | Monodisperse 1.5 µm beads (CV <5%) for consistent immunoassay performance; ultra-low non-specific binding; high-density carboxyl surface for dense antibody loading; rapid <5 second magnetic separation; validated for automated CLIA platforms; comprehensive regulatory support package for IVD manufacturers; scalable manufacturing from grams to kilograms; ISO 13485 quality system |
| Purity | >99.5% polymer-magnetite; endotoxin <0.05 EU/mg; heavy metals <5 ppm each; residual monomers <10 ppm; extractables <0.1%; preservative within specification |
| Concentration | 10-50 mg/mL bead concentration; carboxyl 0.6-1.5 mmol/g; IgG coupling 100-250 µg/mg; particle count approximately 5 × 10^10 particles per mL at 10 mg/mL |
| Activity / Unit Definition | Carboxyl density: 0.6-1.5 mmol/g; IgG coupling: 100-250 µg/mg; coupling efficiency >85%; coupled antibody immunoreactivity >80%; CLIA intra-assay CV <3%; CLIA inter-assay CV <8% |
| Molecular Weight | Not applicable for polymer-magnetite composite; each 1.5 µm bead contains ~10^8-10^9 magnetite nanocrystals in cross-linked polymer matrix |
| Source / Origin | Fully synthetic; polymer-magnetite composite by controlled suspension or emulsion polymerization; carboxyl functionalization by methacrylic acid copolymerization; all raw materials synthetic and traceable; animal-origin-free; TSE/BSE free; manufactured under ISO 13485 in controlled environment |
| pH Range / Optimal pH | Bead stability: pH 2-13; EDC/NHS activation: pH 4.5-6.0; antibody coupling: pH 6.5-9.0; carboxyl groups ionized above pH 5 (pKa ~4.5-5.0); shelf stability: pH 5-9 optimal; coupled beads stable in immunoassay buffers: pH 6-9 |
| Shipping Conditions | Cold pack at 2-8°C; insulated, validated shipper; temperature data logger available for commercial shipments; do not freeze; expedited shipping; non-hazardous; global logistics support |
| Expiration Date / Stability | 24 months at 2-8°C confirmed by real-time monitoring; carboxyl density, coupling capacity, CLIA performance all within specification through expiry; ICH Q1A-compliant stability program; in-use stability: 12 months after opening; forced degradation studies available for regulatory submissions |
| Regulatory / Compliance | Suitable for IVD component manufacturing; ISO 13485:2016 certified; DMF/technical file support available; animal-origin-free certification; TSE/BSE statement; RoHS 3 compliant; REACH compliant; change notification process; quality agreement available; regulatory support team available for customer submissions |
| Compatibility | EDC/NHS coupling compatibility with MES, PBS, borate, carbonate buffers; coupled beads compatible with all common CLIA substrates; compatible with automated liquid handlers (Tecan, Hamilton, Beckman) for bead dispensing; compatible with serum, plasma, whole blood, urine, CSF specimen matrices; surfactant-free for CLIA; can be lyophilized with cryoprotectants for dry reagent formats |
| Recommended Buffer System | Storage: deionized water, 0.02% NaN3 or ProClin 300; activation: 50 mM MES pH 5.5; coupling: 50-100 mM PBS pH 7.4 or borate pH 8.5; quenching: 50 mM ethanolamine pH 8.0; coupled bead storage: PBS pH 7.4, 0.02% NaN3, 0.1-1% BSA (biotin-free optional) |
| Application Notes / Precautions | Fresh EDC/NHS solutions critical—prepare immediately before use; desalt antibody into amine-free buffer before coupling; optimize antibody-to-bead ratio empirically for each antibody; blocking with ethanolamine or BSA after coupling is essential for low background; for diagnostic manufacturing, validate coupled-bead stability under intended storage conditions; bead dispensing precision should be verified on target liquid handler; sonication (5-10 seconds, low power) can resolve coupled bead aggregation; avoid phosphate buffers with calcium/magnesium during coupling (precipitate with carboxyl groups) |
| Batch-to-Batch Consistency | Particle size CV <5% inter-lot; carboxyl density CV <8%; IgG coupling CV <10%; CLIA intra-lot CV <3%; CLIA inter-lot CV <8%; Cpk >1.67 for all critical quality attributes; SPC-controlled manufacturing; lot-to-lot equivalence demonstrated by statistical analysis; bridging studies available for lot changes |
For research use only, not for clinical use.
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