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Why Use SurePath?

The BD SurePath™ liquid-based Pap test is an FDA approved thin-layer cell preparation process intended for use in the screening and detection of cervical cancer,pre-cancerous lesions, atypical cells and all other cytologic categories as defined by The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses.

FOCUS: Cervical Disease Detection!

BD SurePath™ liquid-based Pap test:

  • 64.4% increase in HSIL+ lesions detection in comparison to the conventional Pap smear.
  • Significantly reduces Unsatisfactory and Satisfactory But Limited By (SBLB) cases for potentially fewer patient call-backs.
  • Allows physician to perform Pap tests in a wide variety of clinical presentations (e.g. blood, mucous and inflammation) with maximum confidence in the result due to the proprietary BD SurePath™ Cell Enrichment process used in the lab.
  • FDA-approved for out-of-vial CT/GC testing using the BD ProbeTec™ CT/GC Qx Amplified DNA Assays.

BD SurePath™ Pap test has a unique, easy to use collection process that standardizes the collection process and ensures 100% of the collected sample is sent to the laboratory for processing. No diagnostic cells are discarded in the clinic, as is true with “rinse and swish” systems, which on average can result in the loss of on average, 37% of the collected sample during cell transfer.

BD FocalPoint™ GS Imaging System Intelligent Pap Imaging™ 

The BD FocalPoint™ GS Imaging System combines the automated screening capability of the BD FocalPoint™ Slide Profiler (formerly the AutoPap Primary Screening System) with the precision field location capability of the BD FocalPoint™ GS Review Station. It is intended to assist in cervical cancer screening of BD SurePath™ Pap Test slides to detect evidence of Squamous carcinoma, adenocarcinoma and their precursor conditions.

  • The BD FocalPoint™ GS Imaging System includes screening algorithms for over 100 object analysis features, including both squamous and glandular algorithms to determine potential abnormality
  • Slides will be ranked according to the likelihood of abnormality, and provide relocation and visual review of up to 10 fields of view (FOVs) most likely to contain abnormal cells.
  • System identifies at least 15% of all successfully processed slides with the BD FocalPoint™ Slide Profiler Directed QC Technology™ for a directed QC re-screen.

SurePath


Conventional

Preperation Video

Here is a video of the slide preperation process

SurePath Specimen Life Cycle:

1. Cell Dispersion

Cell population is homgenized within vial by vortexing.

2. Filter (Density) Reagent Added

Density reagent is added to an empty vial.

3. Specimen Transfer

Most of the specimen is slowly transferred to a vial ontop of the density reagent by an automated processfor further processing (the remaining material is saved for additional testing).

4. First Centrifuge

The vial is centrifuged allowing the desinty reagent to filter out debris to the top of the vial while pushing the cells to the bottom.

5. Decant Debris

Most of the debris and density reagent seperated during the centrifuge is decanted.

6. Second Centrifuge

The vial is centrifuged again, pushing the cells further to the bottom creating a cell pellet and forcing the remaining density reagent to the top.

7. Decant Remaing Debris / Fluid

The remaining density reagent and debris seperated in the second centrifuge is decanted, leaving just the cell pellet.

8. Cell Pellet Dispersion

The cell pellet is vortexed to ensure adequate dispersion of the patients cells.

9. Specimen Transfer

The Specimen is loaded into an automated processer for further processing.

10. Automated Aspiration / Staining

An automated software controlled machine aspirates the specimen onto a slide, then stains the slide with a papanicolaou stain procedure. The slides are then manually coverslipped.

11. Automated Review / Analysis of Slide

The Slides are then loaded into the Focal Point device to be triaged by imaging software. Next the device runs its Guidence System (GS) software pinpointing suspicious areas on the slide and once reviewed by a human, the guidence system forces cytotechnicians and pathologists to review these areas by automatically moving their microscopes stage. The software also makes sure a human reviews 100% of the cells on the slide.