Critical Performance Requirements (Sales & Quality Selling Points)

• Accuracy & Specificity: Low false-positive/negative rates (core for clinical trust).
• Sensitivity: Detect low-concentration analytes (e.g., early disease markers).
• Stability: Long shelf life (typically 12-24 months) under specified storage conditions (2-8°C, avoid light).
• Compliance: Meet international standards (CE IVDR, FDA 510(k), ISO 13485) and local regulations (NMPA for China, MHRA for UK).
• Compatibility: Match diagnostic instruments (e.g., automated analyzers, PCR machines) for seamless integration.

• Core Application Scenarios

  • Hospitals & Clinical Labs: Routine checkups, disease diagnosis (e.g., liver/kidney function tests).
  • Rapid Testing (POCT): Emergency rooms, community clinics, home use (e.g., antigen tests, pregnancy kits).
  • Pharmaceutical R&D: Drug efficacy monitoring, clinical trial companion diagnostics.
  • Public Health: Epidemic surveillance (e.g., infectious disease screening).