First, how they are the same:

• They are both FDA approved liquid based methods for GYN cervical cytology.
• They both enhance the epithelial cell component, present the cells in a fairly uniform thin layer for optimal staining and observation, and clear out unwanted inflammation and blood.
• The criteria for interpretation of the resulting slides are essentially the same.
• They both represent an improvement over conventional cervical cytology.
• They take about the same amount of time to produce a slide and subsequently report a result.
• They both produce slides that are acceptable for (different forms of) computer-assisted screening.

The two methods differ in how they accomplish the above [these are all technical details that do not materially affect clinical performance]:

• The methods use different proprietary alcohol blends that are not compatible or inter-convertible
• The vials are different designs so that a SurePrep vial will not fit on a Cytyc machine and a ThinPrep vial will not fit on TriPath machines.
• They use different methods to enhance the cell population: SurePath employs centrifugation and gradient reagent sedimentation while Cytyc employs vortexing and filtration-transfer.
• The SurePath system includes discrete staining of the thin layers; Cytyc does not.
• They differ in the cost to produce a slide.
• They differ in the cell area size on the produced slide; 13 mm dia For SurePrep, 21 mm dia for Cytyc. In consequence of this and the fact that both preps contain similar numbers of cells, the SurePrep samples are ‘denser’ – less empty space between cells and groups than the ThinPreps.

Yes.

No, and the point is that they don’t have to be. We, Gynecor and Bostwick Laboratories are CMS (CLIAA) approved to perform complex testing based on our validation of the testing in this assay system. We maintain this approval through constant oversight and regular inspection by the College of American pathologists, a deemed agency of the CMS.

For many reasons, but to list a few:

• Immediate fixation is manifestly superior to poor and delayed fixation
• The lab gets much more of the sample to read because a conventional smear sampling device is thrown in the trash with most of the patient’s cervical cells still on it (clinicians have been throwing away the majority of the collected sample for most of the 50 years that Paps have been in existence)
• Even placement of the cells on the slide mean that the cells themselves do not get in each others way, (no piles or clumps) so we can see them clearly enough to tell what they are (abnormal or not)
• Reducing/eliminating blood and inflammation means we can see more epithelial cells and see them better
• Cell staining is technically better in a uniform LBP cell preparation than in an uneven clumpy conventional one.
• Immediate fixation and uniform thin layer presentation without non-linear artifacts means that observers can appropriately refer to published criteria and apply them in a uniform objective manner without guessing about how artifacts are distorting the criteria.
• All of this means better signal to noise ratio, which accounts for the observed improvement in sensitivity of LBP over conventional smears in study after study.