Automatic Medical PCR Analysis System

Core Applications

1. Rapid Infectious Disease Management

• Multiplex panels for simultaneous detection of 20+ pathogens (respiratory/STI/HAI)

• <90-minute turnaround for SARS-CoV-2/Influenza/RSV with ≥98% sensitivity

• Antimicrobial resistance gene profiling (e.g., MRSA, Carbapenemase)

2. Precision Oncology & Genetic Testing

• qPCR-based BRCA/EGFR mutation analysis

• Minimal residual disease (MRD) monitoring in leukemia

• Pharmacogenomics for warfarin/5-FU dosing guidance

3. Blood Safety & Public Health

• Batch testing for HIV/HBV/HCV in blood banks

• Outbreak tracing via pathogen strain typing

Operational Benefits

• 80% reduction in manual steps vs. conventional PCR

• 24/7 operation with onboard refrigeration (reagents stable for 3 months)

• CLIA-waived protocols for point-of-care deployment

Compliance-Ready:

▸ CE-IVD/FDA-cleared assays
▸ 21 CFR Part 11 compliant data integrity
▸ IVDR-ready performance documentation

Deployment Scenarios:

• Core Labs: Centralized high-volume testing

• Hospital STAT Labs: ED and ICU rapid panels

• Mobile Units: Pop-up testing for epidemic control