Pap Test Questions

  • Is SurePath FDA approved?
    • Yes, since 2004.

  • Is SurePath FDA approved for ancillary tests (HPV, CT, NG, etc)?
    • No, and the point is that they don’t have to be. We, Gynecor and Bostwick Laboratories are CMS (CLIA) 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. We offer PCR based HPV testing off of the SurePath vial, which we believe to be a more accurate test than the FDA approved method. In addition, cystic fibrosis, herpes subtyping, Chlamydia and gonnorhea can all be run off of the SurePath vial at Gynecor.

  • Why is a liquid based Pap better than traditional slides?
      • Immediate fixation is manifestly superior to poor and delayed fixation
      • The laboratory 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