Simplex TAS101 CRP

Product Overview

SimplexTAS™ 101 CRP Reagent Cartridge, used with the SimplexTAS™ 101 Analyzer, is intended for the quantitative determination of C-reactive protein (CRP) in human whole blood. The Reagent Cartridge is for in vitro diagnostic use by healthcare professionals only.

Key Features

• High-Sensitivity Inflammation Marker: Vital for detecting systemic inflammation associated with bacterial infections, active autoimmune disorders, tissue injury, and sepsis.
• Turbidimetric Latex Immunoassay: Employs high-quality goat anti-human CRP polyclonal antibodies conjugated with latex beads to induce precise agglutination proportional to CRP concentration.
• All-In-One Cartridge System: Minimizes manual errors with a pre-filled reaction container, built-in sampling capillary, and automatic dilution.

Method & Test Principle

This assay is based on a turbidimetric immunoassay. CRP present in patient samples undergoes an antigen-antibody reaction with Goat anti-human CRP polyclonal antibody-latex conjugates, causing agglutination. The concentration of CRP is determined by measuring this agglutination as the rate of change in absorbance.

Sample Specifications

• Sample Type: Fresh capillary blood, or venous blood (EDTA or heparin-treated tubes).
• Required Volume: 10 μL.
• Sample Stability (Venous): Best used within 3 days when stored refrigerated (2–8 °C). Do not freeze.

Storage & Stability

• Storage: 2–8 °C (36–46 °F). Do not freeze.
• Unopened: Stable until the expiration date printed on the box.
• Opened Tray: Use cartridges within 2 months once the seal of the cartridge tray is opened.
• Pre-test Warm Up: Allow cartridges to reach room operating temperature (18–32 °C) for at least 30 minutes before running the analysis.

Performance Characteristics

• Measurement Range: 5.0 - 200.0 mg/L (47 - 1,905 nmol/L)
• Expected Normal Values: < 10 mg/L (< 92 nmol/L)
• Clinical Correlation (R): 0.9938 (Capillary blood) & 0.9965 (Venous blood)
• Precision (%CV): Low Level: 4.2% (Mean 23.8 mg/L) | High Level: 4.0% (Mean 132.3 mg/L)
• High Interference Resistance: No significant interference from Hematocrit (20 - 60%), Bilirubin (up to 20 mg/dL), Triglycerides (up to 1,000 mg/dL), Acetaminophen (100 mg/dL), Ascorbic Acid (20 mg/dL), or Salicylic Acid (30 mg/dL).

Materials Provided

• 20 SimplexTAS™ 101 CRP Reagent Cartridges
• 1 Package insert
• 1 RFID label