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Pro-Amp™: High-Complexity Isothermal PCR Panels for Infectious Disease Diagnostics

Isothermal diagnostics laboratory

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.