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| Product Name | Immunoturbidimetric Assay Sample Diluent, PEG-Enhanced, Low Background |
| Catalog No. | ATRD-0029 |
| Description | PEG-enhanced sample diluent with optimized ionic strength for immunoturbidimetric assays measuring specific proteins (CRP, immunoglobulins, complement factors, apolipoproteins, albumin, transferrin, etc.) on automated chemistry analyzers. The polyethylene glycol (PEG 6000) accelerator promotes immune complex formation in the antigen-excess zone while maintaining low reagent blank optical density. Glycine-NaCl buffering system minimizes nonspecific protein aggregation that causes falsely elevated turbidimetric signals in lipemic, icteric, and hemolyzed clinical specimens. |
| Intended Use | Sample dilution for immunoturbidimetric quantification of serum proteins on automated clinical chemistry analyzers, particularly for high-concentration analytes that exceed the assay measuring range without predilution. |
| Principle / Technology | PEG 6000 reduces protein solubility by excluded volume effect, enhancing rate and extent of antigen-antibody immune complex formation; glycine buffer system maintains optimal pH for immunoprecipitin reaction; controlled ionic strength minimizes nonspecific aggregation of serum matrix proteins. |
| Detection Method | Sample automatically diluted by analyzer at pre-programmed ratio; turbidimetric signal measured at 340 nm or 570-700 nm depending on particle size; result calculated from calibration curve. |
| Sample Type | Human serum, lithium heparin plasma; not recommended for EDTA plasma due to calcium chelation effects on complement protein measurements. |
| Performance Range / Specifications | Linear dilution recovery 90-110% for CRP (0.5-300 mg/L), IgG (2-40 g/L), IgA (0.5-8 g/L), IgM (0.3-5 g/L), transferrin (1-6 g/L), and albumin (10-60 g/L). |
| Sensitivity / LOD | Reagent blank absorbance <0.05 AU at 340 nm; detection capability sufficient for sample blank subtraction in the presence of moderate lipemia (triglycerides <500 mg/dL), icterus (bilirubin <20 mg/dL), and hemolysis (Hb <500 mg/dL). |
| Specificity | Optimized for immunoturbidimetric specific protein assays; does not cause nonspecific precipitation of albumin, transferrin, or immunoglobulin fractions in the absence of specific antibody. |
| Reaction Conditions / Protocol | Immune complex formation proceeds within 5-10 minutes at 37 °C after mixing sample, antibody reagent, and diluent; endpoint or rate measurement per analyzer protocol. |
| Components / Formulation | Polyethylene glycol 6000 4% w/v, glycine 100 mM, sodium chloride 150 mM, sodium azide 0.05% w/v as preservative, pH 7.4, deionized water. |
| Storage Conditions | Store at 2-8 °C; do not freeze; protect from light. |
| Shelf Life | 24 months from date of manufacture in unopened container. |
| Package Specifications | 2 × 50 mL, 4 × 50 mL, 6 × 50 mL analyzer-compatible bottles. |
| Product Form | Clear, colorless to pale yellow viscous liquid. |
| Quality Control | Each lot tested for reagent blank absorbance, PEG concentration verification, osmolality, pH, and performance in at least three immunoturbidimetric specific protein assays. |
| Key Features | PEG 6000-enhanced immune complex formation; low reagent blank optical density; glycine buffer minimizes nonspecific aggregation; compatible with major chemistry analyzer platforms; long on-board stability. |
| Purity | PEG 6000 ≥99% purity; glycine ≥99.5% USP grade; sodium chloride USP; sodium azide ≥99%. |
| Concentration | Ready-to-use 1× formulation; PEG 6000 at 4% w/v (optimum for immunoturbidimetric enhancement without nonspecific precipitation). |
| Activity / Unit Definition | Immune complex enhancement factor 3-5× compared to saline-only diluent as measured by rate of absorbance change at 340 nm. |
| Molecular Weight | PEG 6000: average molecular weight 5,400-6,600 g/mol. |
| Source / Origin | Synthetic PEG from pharmaceutical-grade ethylene oxide polymerization; analytical grade buffer components. |
| pH Range / Optimal pH | pH 7.4 ± 0.1 at 25 °C. |
| Shipping Conditions | Ambient or cold pack (2-8 °C); avoid freezing. |
| Expiration Date / Stability | 24 months at 2-8 °C unopened; on-board analyzer stability 30-60 days depending on platform; discard if turbidity develops. |
| Regulatory / Compliance | For in vitro diagnostic use as accessory reagent; manufactured under ISO 13485 quality system. IVDR compliant where applicable. |
| Compatibility | Compatible with Roche Cobas c-series, Abbott Architect c-series, Siemens Atellica/ADVIA, Beckman Coulter AU/DxC immunoturbidimetric assay channels. Verify dilution linearity per CLSI EP34 for each assay parameter. |
| Recommended Buffer System | 100 mM glycine buffer with 150 mM NaCl, pH 7.4. |
| Application Notes / Precautions | Mix bottle gently by inversion before loading on analyzer to ensure homogeneous PEG distribution. Do not shake vigorously as PEG solutions foam readily. If sample shows prozone (hook) effect at low dilution, prepare higher dilution factor manually. Monitor reagent blank daily; increasing blank may indicate PEG or protein precipitation — replace bottle. Verify new lot with QC materials before routine use. |
| Batch-to-Batch Consistency | PEG concentration within ±0.2% w/v; pH within ±0.1 units; reagent blank absorbance within ±0.01 AU of reference lot. |
For research use only, not for clinical use.
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