Gynecologic cytopathology, popularly known as the Pap Smear test, was first developed by and named for Dr. George Papanicolaou in the 1920's to detect cancer of the uterine cervix and its precursors. Before the Pap Smear, cervical cancer was one of the leading causes of cancer death in women. Over the years, the widespread use of this test in developed countries has reduced cervical cancer to a relatively rare disease. Thus, the traditional Pap Smear test is the greatest cancer prevention story in the history of medicine.

Traditionally, after a Pap Smear is obtained from the patient and received by a cytology laboratory, it is stained with special pigments and prepared for examination by a cytotechnologist, a specially trained professional who screens the cells under a microscope and identifies and marks any abnormalities. Smears deemed abnormal are then reviewed by the pathologist who renders a diagnosis and recommendation for treatment and/or further tests if necessary. This process, augmented by strict quality controls including directed and random review of smears deemed normal and repeated year after year results in a test which, relative to other tests in medicine, is highly accurate.

New Pap Smear Technologies offered by OPA

Recently, attention has been directed at the rare cancers missed by the highly accurate traditional Pap Smear test. No test in medicine is perfect or ever will be, however this attention has led to new technologies intended to reduce the risk of missing this potentially fatal cancer.

To this end Drs. John Abele, Anthony Mathios, and Daniel Egerter are pleased to offer the FocalPoint® Primary Screening System (TriPath). FocalPoint is an automated Pap smear analysis device which has been shown to enhance traditional manual evaluation of cervical cytologic specimens by reducing the number of significant abnormalities missed by 33% and the accuracy of the test by 15%.¹ The system is approved by the federal Food and Drug Administration for primary screening of Pap smears. Utilizing high-speed video technology and image interpretation, the FocalPoint machine identifies those slides most likely to contain abnormalities and marks them for further human review and interpretation.

Every conventional Pap smear reviewed at OPA is first analyzed by the FocalPoint system. Those specimens determined to be most likely to have significant abnormalities are reviewed by expert cytotechnologists and then, when appropriate, by one of the board certified cytopathologists. In addition, any smears identified as originating from clinically "high risk" patients receive automatic review by the machine, a cytotechnologist, and an MD cytopathologist.

The FocalPoint system enhances traditional manual review in several ways. It allows our cytotechnologists and pathologists to devote more time to those slides most in need of review. Also, the machine, unlike humans, can operate 24 hours a day immune to eyestrain, fatigue and distractions, all of which could lead to test errors.

In addition, the FocalPoint system requires no special collection devices and is designed to analyze conventionally obtained Pap smears.

Other technologies have been shown to improve on the traditional Pap Smear; however, the experience of our pathologists, all specialists in Cytopathology, has led OPA to adopt this technology as it addresses the problem of errors in recognition of potentially abnormal cells.

More recently, OPA offers SurePath® (TriPath), a liquid-based thin layer technology for Pap smear collection. Rather being smeared directly onto a slide as is a conventional Pap smear, the cervical sample is deposited directly into an ethanol-based liquid fixative (see Protocol). The cells of interest are enriched by automated processor which concentrates the cells of interest while removing obscuring material and blood and excess inflammatory cells. The processor deposits an enriched, representative portion of the cells onto a glass slide in a uniform thin layer for evaluation by the cytotechnologist.

Advantages of the SurePath® over conventionally obtained Pap smears^2,3,4 include a decrease in unsatisfactory and limited samples, resulting in fewer patient callbacks for repeat sampling and associated patient anxiety. Reasons for include: 1) all of the cervical sample is submitted to the laboratory, 2) the possibilities for technical errors at the time of the patient examination are reduced, and 3) the enrichment process removes obscuring material. In addition, the uniform thin layer of cells on the slide is in many ways easier to view and interpret under the microscope than a conventional smear.

Furthermore, SurePath® slides are the only liquid-based pap smear approved for evaluation by the FocalPoint® Primary Screening System described above. Thus, these patients can benefit from both of these technologies.

As will always continue to be the case, there is no technological solution to prevent all false negative Pap smears at the 100% level. Even machines will miss some cancers. That is why periodic physical examination, history, and Pap smears performed at recommended intervals remain the most important components of cervical cancer prevention.

¹Wilbur DC, Prey MU, Miller WM, et al. The AutoPap System for primary screening in cervical cytology. Acta Cytologica 1998; 42: 214-220.

²Hutchiinson M, et al. Study of Cell Loss in the Conventional Pap Smear. Acta Cytologica; 1992.

³Davey DD, et al. Terminology and Specimen Adequacy in Cervicovaginal Cytology. Arch Pathol Lab Med; 1992.

⁴Sprenger, et al. The False Negative Rate in Cervical Cytology. Acta Cytologica; 1996.