SurePath™ Liquid-Based Cytology System

Medical Devices · Cervical Cancer Screening · FDA & NMPA Certified

SurePath™ Liquid-Based Cytology System

The SurePath™ LBC system uses a proprietary sample collection method and patented centrifugal sedimentation technology — the third-generation cytology testing method. It delivers automated, standardised, high-throughput slide preparation with industry-leading specimen adequacy rates and the highest FDA-certified cancer precursor detection rate compared to conventional Pap smears.

  • FDA certified — only LBC method proven to reduce unsatisfactory rate by 58%
  • HSIL+ detection rate 64.4% higher than conventional Pap smear
  • LSIL detection rate improved by 107%
  • 100% sample collection — no cell loss during transport
  • Gynaecological & non-gynaecological applications
  • Compact design: 770 × 580 × 650 mm · 65 kg

Product Overview

SurePath™ liquid-based cytology is the world’s most clinically validated cervical screening technology, backed by over two decades of large-scale FDA clinical evidence. Its unique sedimentation-based slide preparation preserves the three-dimensional cellular structure, producing a clear, uniform monolayer free from obscuring blood, mucus and inflammatory cells.

The PrepStain™ Slide Processor automates the entire workflow — from sample pre-treatment and cell enrichment to slide preparation and Papanicolaou staining — completing a batch of 24 slides in just 40 minutes. Each slide uses an independent reagent cartridge to eliminate cross-contamination, and the closed waste-liquid system reduces fume exposure in the laboratory.

Clinical Performance vs. Conventional Pap Smear (FDA Evidence)

  • Unsatisfactory specimen rate reduced by 58%
  • HSIL+ (high-grade squamous intraepithelial lesion) detection rate +64.4%
  • LSIL detection rate +107%
  • 100% of collected cells transferred to slide — no cell loss
  • CIN2+ sensitivity 98.2%

Application Areas

  • Gynaecological cervical cancer mass screening
  • Non-gynaecological specimens: sputum, pleural/ascitic fluid, bronchial brushing, urine
  • P16/Ki-67 dual immunocytochemistry staining (cervical triage)
  • HPV co-testing (shared SurePath™ vial)
SurePath™ Liquid-Based Cytology System
Model PrepStain™ Slide Processor
Dimensions 770 × 580 × 650 mm (W × D × H)
Weight 65 kg
Throughput 1–24 slides per batch · 40 min per batch of 24
Slide Preparation Method Sedimentation (preserves 3D cell structure)
Staining Method Independent single-slide drop staining (no cross-contamination)
Applications Gynaecological LBC · Non-gynaecological cytology · Immunocytochemistry (dual / single stain)
Reagent System Independent cartridge per slide; closed waste-liquid system
Operating Temperature 25–30 °C
Regulatory Status FDA 510(k) cleared · NMPA registered · CE IVD
Compatible Media SurePath™ preservative fluid

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