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| Product Name | Latex Particle Assay Diluent, Polystyrene Bead Compatible, Glycine Buffer |
| Catalog No. | ATRD-0030 |
| Description | Glycine-buffered diluent optimized for latex-enhanced immunoturbidimetric and particle-enhanced nephelometric assays using antibody-coated polystyrene or carboxylate-modified latex particles. The glycine buffer at pH 8.2 provides optimal conditions for antibody-coated latex particle stability and immune agglutination kinetics. Contains a proprietary nonionic surfactant blend that prevents latex particle aggregation during storage and on-board incubation while allowing efficient immune complex formation. Bovine serum albumin (BSA) coating agent minimizes nonspecific particle-protein interactions that cause false-positive agglutination signals in samples with rheumatoid factor or heterophilic antibodies. |
| Intended Use | Reaction medium and sample diluent for latex-enhanced immunoturbidimetric and nephelometric assays measuring low-concentration analytes (hs-CRP, D-dimer, cystatin C, β2-microglobulin, rheumatoid factor) on automated analyzers. |
| Principle / Technology | Glycine buffer at pH 8.2 maintains antibody-latex conjugate stability and zeta potential; nonionic surfactant prevents particle self-aggregation; BSA blocks nonspecific protein binding to latex surface; controlled ionic strength optimizes immune agglutination rate without salt-induced particle precipitation. |
| Detection Method | Sample automatically mixed with latex reagent and diluent on analyzer; agglutination monitored by absorbance at 570-700 nm or nephelometric light scatter at 670-840 nm depending on latex particle size (typically 50-300 nm diameter). |
| Sample Type | Human serum, lithium heparin plasma, EDTA plasma, citrate plasma (verify with specific assay package insert for anticoagulant compatibility). |
| Performance Range / Specifications | Latex particle suspension stability >48 hours at 2-8 °C without visible aggregation; reaction baseline absorbance drift <0.001 AU/min at 570 nm; nonspecific agglutination rate <0.002 AU/min in the absence of specific antigen. |
| Sensitivity / LOD | Detection of low-concentration analytes achievable with appropriate antibody-latex conjugate; diluent contribution to blank signal <0.01 AU at measurement wavelength. |
| Specificity | BSA and surfactant system prevents rheumatoid factor interference causing false-positive latex agglutination; does not cause nonspecific agglutination of uncoated latex particles in the absence of sample. |
| Reaction Conditions / Protocol | Immune agglutination reaction proceeds at 37 °C; endpoint reading after 5-10 minutes incubation; kinetic reading mode for rate nephelometry. |
| Components / Formulation | Glycine 50 mM, sodium chloride 100 mM, BSA 0.1% w/v, nonionic surfactant blend 0.05% v/v, sodium azide 0.05% w/v, pH 8.2, deionized water. |
| Storage Conditions | Store at 2-8 °C; do not freeze; protect from light. |
| Shelf Life | 18 months from date of manufacture in unopened container. |
| Package Specifications | 2 × 50 mL, 4 × 50 mL, 6 × 50 mL analyzer bottles; 100 mL bulk bottle for reagent preparation. |
| Product Form | Clear, colorless to pale yellow liquid; low viscosity. |
| Quality Control | Each lot tested for absorbance at 570 nm and 700 nm, latex particle compatibility (agglomeration test with 100 nm and 200 nm polystyrene particles), pH, osmolality, and preservative concentration. |
| Key Features | Glycine buffer pH 8.2 optimized for latex agglutination; BSA blocks nonspecific interactions; surfactant prevents particle self-aggregation; low reagent blank; compatible with 50-300 nm latex particles; long reagent stability on analyzer. |
| Purity | Glycine ≥99.5%; BSA Fraction V ≥96% by electrophoresis; sodium azide ≥99%; water 18.2 MΩ·cm. |
| Concentration | Ready-to-use 1× formulation. |
| Activity / Unit Definition | Latex particle stabilizing activity confirmed by maintenance of monodisperse particle size distribution (PDI <0.1) after 48-hour incubation at 37 °C. |
| Molecular Weight | Glycine: 75.07 g/mol; BSA: ~66.5 kDa; nonionic surfactants: proprietary mixture. |
| Source / Origin | Synthetic glycine and buffer salts; BSA from BSE-free bovine plasma; proprietary surfactant synthesis. |
| pH Range / Optimal pH | pH 8.2 ± 0.1 at 25 °C. |
| Shipping Conditions | Ambient or cold pack (2-8 °C). |
| Expiration Date / Stability | 18 months at 2-8 °C; after opening, use within 60 days and store at 2-8 °C between uses. |
| Regulatory / Compliance | For in vitro diagnostic use as accessory reagent; manufactured under ISO 13485 quality management system. |
| Compatibility | Compatible with polystyrene (PS), carboxylate-modified polystyrene (CML), and poly(methyl methacrylate) (PMMA) latex particles in 50-300 nm size range. Compatible with major clinical chemistry and specific protein analyzer platforms. Verify specific antibody-latex conjugate compatibility with each assay. |
| Recommended Buffer System | 50 mM glycine buffer, 100 mM NaCl, pH 8.2. |
| Application Notes / Precautions | Gentle inversion before use; do not vortex as vigorous mixing may shear latex particles. Pre-warm to room temperature before loading on analyzer to prevent bubble formation in fluid lines. If latex reagent shows visible aggregation in diluent blank wells, discard both reagent and diluent — this indicates formulation incompatibility or contamination. Verify prozone safety range with high-concentration samples. |
| Batch-to-Batch Consistency | pH within ±0.1 units; absorbance at 570 nm within ±0.005 AU of reference lot; particle agglomeration test negative. |
For research use only, not for clinical use.
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