Unsatisfactory Pap Test: Avoid the Frustration

By: Mike Schaaf, Cytology Supervisor

An "unsatisfactory" Pap test result (unsat) can be caused by a number of factors, including poor sample collection, obscuring inflammation or blood, and use of lubricants. Although this unsatisfactory category constitutes 1% to 2% of all Pap tests, patients with unsats are more likely to have histories of abnormalities and are at increased risk of harboring pre-cancer or invasive cervical cancer; therefore it is important to monitor them closely.

According to the Bethesda 2001 Guidelines, adequate squamous cellularity for conventional Pap tests is defined as having an estimated minimum of 8,000 to 12,000 well-preserved and well-visualized squamous epithelial cells. For liquid-based Pap tests, the number is 5,000. This estimation is determined by comparison with computer-generated reference images, rather than by counting.

Inadequate cellularity or obscuring factors that limit the ability of the cytotechnologist or pathologist to observe the squamous cells in the sample will result in an unsatisfactory Pap test.

Most unsatisfactory Paps can be directly related to insufficient material, poor fixation, obscuring inflammation, excessive blood or lubricant interference.

Specimen collection and fixation are key factors in obtaining adequate and representative samples for analysis. Several steps can be taken to help prevent unsatisfactory test results, including the use of proper collection devices and techniques. If you are using the SurePath Pap liquid pap, it is important to remove the head of the collection device and include it in the Pap vial. If you are using the ThinPrep liquid Pap, it is equally important that you rinse the collection device thoroughly in the Pap vial, but do not place the collection device in the vial. Conventional Pap users should spray fix the specimen on the slide immediately after collection.

Partially or completely obscuring inflammation or blood can be avoided by not sampling during periods of active infection or bleeding and avoiding intercourse and use of tampons within 48 hours of specimen collection.

It is important to note that lubricant increases the risk of contaminating or obscuring the cellular sample with both conventional Pap tests as well as all liquid based methods. Because of this, organizations such as Clinical and Laboratory Standards Institute (formerly NCCLS) have suggested that lukewarm water be used to lubricate and warm the speculum.

If lubricant must be used due to patient discomfort or other circumstances, it should be applied sparingly on the outer portion of the speculum with great care to avoid the tip.

The following table lists the names of lubricants that do not contain the interfering substance along with distributors known to us. Please note the list is not exhaustive and is merely a starting point for your reference.

The sterile version of K-Y® Jelly, manufactured by Johnson & Johnson is no longer available and therefore has been removed from the list noted above. We are only aware of personal lubricants being offered under the K-Y® brand at this time and the formulation is not the same as the sterile version.

Excessive cytolysis or autolysis in a premenopausal woman who has a cervix or specimens not representative of the anatomic site can also result in an unsatisfactory Pap Test.

According to the American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines for the management of patients with "unsatisfactory for evaluation" Pap test results, patients should have repeated testing within 2 to 4 months. The guidelines recommend repeat testing in 12 months for patients with other limiting factors such as blood or obscuring inflammation and lack of an endocervical component.

For additional information on Pap collection, please contact your CellNetix Partner Relations Representative at (866)236-8296.