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Shandon PapSpin™ Frequently Asked Questions

1. Does the PapSpin detect more clinically significant abnormals than the conventional Pap smear?

 

In a study by Weynand et al.1, of 3,000 cases there was a 17% increase in the detection of HSIL.  Additionally, the PapSpin improves the quality of the slide in a ratio of 1 to 5 in favor of PapSpin1 by reducing mucus, blood and inflammatory obscuring factors and eliminating air drying artifacts allowing for easier location of abnormal cells.

1Weynand B, Berliere M, Haumont E, Massart F, Pourvoyeur A, Bernard P, Donnez J,  Galant C.  A new, liquid-based cytology technique. Acta Cytol 2003 ;47 :149-153.



2. Does the increased sensitivity for HSIL result in a loss of specificity?

  No. Additional studies in process have shown that the increased detection of lesions by the PapSpin does not result in an increase in false-positive diagnoses. One as yet unpublished study at Johns Hopkins Medical Institutions found the PapSpin method to have fewer false positives and a greater proportion of true negatives in comparison to the conventional Pap smear. Additionally, the study by Weynand et al. did not show decreased specificity.


3. The PapSpin only examines a proportion of the cells in the vial. How do you know you are not leaving important cells unexamined?

  The PapSpin method allows for 100% of the patient's collected cells to be captured in the specimen vial of PapSpin Collection Fluid. Once the cells are in suspension, by vortexing, all cells in the randomized, homogeneous sample have an equal opportunity for presentation on the slide, resulting in a more representative sampling of the cervical specimen. Thus, the subsample of cells on the PapSpin slide can be anticipated to represent the sampled cell population better.

With a conventional Pap smear, the sampling instrument is discarded with the majority of the cellular material from the patient1, suggesting nonrandom subsampling. The conventional Pap smear does not involve a randomizing process and may not be representative of the cervical specimen. 1Goodman A, Hutchinson ML. Cell surplus on sampling devices after routine cervical cytologic smears. A study of residual cell populations. J Reprod Med 1996;41:239-241.


4. Do infectious agents and background clues remain on the PapSpin slide?

  Yes. The gentle cytocentrifugation process of the PapSpin method allows for all diagnostically important components to be identified on the slide. Weynand et al. found that fungal infections were more easily diagnosed on PapSpin slides in comparison to conventional smears.


5. Is the PapSpin FDA-approved ?

  Not at this time, although we are in the process of seeking approval. The Food and Drug Administration (FDA), Center for Devices and Radiological Health, Hematology and Cytology Branch, has received the PMA Clinical Protocol for the PapSpin Liquid-Based Gynecological Test for Cervical Cancer Screening from the Clinical Diagnostics Division of Thermo Fisher Scientific. A clinical trial involving cervicovaginal samples from 7,000 subjects to be evaluated at 3 cytology laboratories in the United States will be required. Currently, the PapSpin test is CE marked and it conforms with all essential requirements for the In Vitro Diagnostic Directive (IVDD).


6. Some PapSpin slides do not contain endocervical cells. Is there a decrease in endocervical recovery with the PapSpin method?

  No, however, the laboratory may notice a decrease in endocervical recovery upon initial implementation of the PapSpin method. This is usually due to clinician inexperience with the broom-type sampling device used with the method. It is important to communicate with the physicians and instruct them on proper use of the Wallach Papette™. Additionally, a supplementary endocervical cytobrush may be provided.

Greater than 95% of slides made with a broom-type device alone will contain an endocervical component. However, proper technique and experience with broom samplers are important factors in outcome. The proper technique is described below:

  • Insert the central bristles into the cervical canal deep enough to allow the shorter bristles to fully contact the ectocervix.
  • While maintaining gentle pressure, rotate the brush 5 times in a clockwise direction.


7. How does the quality and cellular morphology of the PapSpin test compare to a conventional Pap smear?

  The quality and cellular morphology of the PapSpin slide is much better than a conventional Pap smear. The PapSpin method produces an evenly distributed thin layer of cells in a clearly defined 21 x 14 mm screening area. The cells are beautifully preserved with maintained morphology very similar to a conventional Pap smear. There is little to no morphology training required, unlike other thin layer systems which require much time to become accustomed to the change in cellular appearance. Air drying is eliminated and mucus, blood and inflammatory obscuring factors are significantly reduced, resulting in a clearly better Pap test.


8. What is the processing throughput with the PapSpin method and how can workflow be optimized?

  Approximately 48 samples can be processed per hour. Twelve samples are cytocentrifuged per run for 5 minutes. The workflow can be optimized by using an additional Cytospin® or additional Sealed Heads. The additional Sealed Heads can be loaded while the Cytospin is running.


9. Can HPV testing be performed from residual material in the vial?

  Yes. We have customers who are successfully performing HPV testing from residual specimen using both PCR and Hybrid Capture® 2 methods.


10. Why should my laboratory use the PapSpin test?

 
  • Will provide better quality cervical cancer screening program
  • Easy, efficient procedure for all members of the screening program, including patient, physician, lab technician and cytologist
  • More economical than other liquid-based Pap tests, with a low cost per test and minimal to no (if the lab already owns a Cytospin®) instrumentation investment
  • Batch processing: 12 samples per run; throughput can be optimized with use of multiple Sealed Heads
  • More compatible with consistent automated coverslipping due to resultant thin layer slides
  • Will provide a reduction of inadequate samples
  • Will improve the quality of the Pap slide
  • Will increase detection of clinically significant disease
  • Will provide increased screening productivity
  • Reduced anxiety for women
  • Time savings at sample collection
  • Availability of additional testing from residual specimen in the vial