Pro-Lab Diagnostics USA offers a comprehensive menu of Pro-Amp™ isothermal nucleic acid amplification panels designed for use in high-complexity, CLIA-certified laboratories. These panels support the rapid, accurate multiplex detection of infectious disease pathogens using proprietary ProAmpHT Isothermal Amplification technology — a cost-effective, high-throughput alternative to conventional PCR.
What is Pro-Amp™?
Pro-Amp™ panels are isothermal NAAT (Nucleic Acid Amplification Test) assays that amplify target genetic material at a constant temperature, eliminating the need for thermal cycling instrumentation. This approach delivers several advantages over traditional PCR:
- Faster time-to-result — amplification completed in 15–60 minutes
- Simplified instrumentation — no thermocycler required
- High sensitivity and specificity equivalent to PCR
- Lower operational complexity for laboratory staff
- Integrated resistance gene detection in a single assay
Available Panel Menu
Pro-Amp™ panels cover the most clinically significant infectious disease categories. Each panel is fully customizable to include the specific targets most relevant to your patient population.
| Panel | Key Targets | Specimen Type |
|---|---|---|
| UTI Panel | 19 basic + 11 extended uropathogens, resistance genes | Urine |
| Wound Infection Panel | 16 basic + 11 extended organisms | Wound swab / tissue |
| Respiratory Panel (RPP) | 18 basic + 24 extended viral/bacterial targets | NP swab / BAL |
| Gastrointestinal (GI) Panel | 12 basic + 8 extended enteric pathogens | Stool |
| Vaginitis Panel | 17 bacterial/fungal targets | Vaginal swab |
| STI Panel | 11 sexually transmitted pathogen targets | Urogenital swab |
| Candidiasis Panel | 7 Candida species | Multiple specimen types |
| C. diff Panel | C. difficile + Toxin A/B | Stool |
| Antibiotic Resistance Panel | Beta-lactam, methicillin, vancomycin resistance genes | Multiple specimen types |
| Nail Fungus Panel | 11 dermatophyte and fungal targets | Nail clipping / scraping |
Resistance Gene Integration
A key differentiator of the Pro-Amp™ platform is the integration of resistance gene profiling directly into standard panels. Rather than requiring separate reflex testing, resistance genes including KPC, NDM, OXA-48, VIM, IMP, mecA, mecC, vanA, and vanB are detected simultaneously with pathogen identification — providing clinicians with actionable antibiotic stewardship data from a single test run.
Clinical Impact
Integrated resistance gene data enables clinicians to de-escalate from empiric broad-spectrum therapy within 24 hours, reducing C. diff risk, improving outcomes, and supporting facility-level antibiotic stewardship programs.
Laboratory Requirements
Pro-Amp™ panels are classified as high-complexity tests under CLIA regulations (42 CFR Part 493). Performing laboratories must hold a CLIA certificate of high complexity and meet applicable personnel and quality system requirements. Pro-Lab Diagnostics provides comprehensive onboarding support, validation documentation, and ongoing technical consultation for implementing laboratories.
Ordering and Distribution
Pro-Amp™ panels are distributed through Thermo Fisher Scientific and Cardinal Health, and are also available directly through Pro-Lab Diagnostics USA. Contact our team to discuss panel customization, volume pricing, and implementation support.
Most implementing labs do not buy molecular panels in isolation. They also need environmental compliance with Pro-Temp, inventory and QC control with Pro-LIMS Inventory, and a physician-office-lab commercialization path where appropriate through Pro-Lab POL.