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Test ID: 82037    
ThinPrep Screen, Without Physician Interpretation

Useful For Suggests clinical disorders or settings where the test may be helpful

Detection of cervical carcinoma or intraepithelial lesions when screening women for possible cervical neoplasia

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

The ThinPrep Pap test is an alternative preparation method for the cervical Pap screening test. The method utilizes a liquid-based technique that replaces the direct smear method of the conventional Pap screen. This method is 1 of several technologies developed to improve visualization of cellular material by reducing smearing trauma, air drying artifact, and obscuring blood and inflammation. In addition, variability in smearing technique is eliminated as the majority of processing and preparation is performed in the laboratory under controlled conditions.

 

Squamous cell carcinoma of the cervix is believed to develop in progressive stages from normal through precancerous (dysplastic) stages, to carcinoma in situ, and eventually invasive carcinoma. This sequence is felt to develop over a matter of years in most patients.

 

Follow-up of the cervical Pap abnormality "atypical squamous cells of undetermined significance (ASCUS)" is costly and frustrating to patients and clinicians because a large percentage of these patients have normal colposcopic and biopsy findings. Yet, a significant percentage (10-15%) will have an underlying high-grade squamous intraepithelial lesion (HSIL).

 

If the patient has been previously diagnosed with an abnormal Pap result or is at high risk, considering ordering the diagnostic test 82039 / ThinPrep Diagnostic Without Physician Interpretation rather than this test.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Satisfactory for evaluation. Negative for intraepithelial lesion or malignancy.

Note: Abnormal results will be reviewed by a pathologist at an additional charge.

Interpretation Provides information to assist in interpretation of the test results

Standard reporting, as defined by the Bethesda System (TBS) is utilized.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

The Pap test is a screening test for cervical cancer with inherent false-negative results. A negative human papillomavirus (HPV) test or Pap smear result does not preclude the presence of carcinoma or intraepithelial lesion. The false-negative rates of the Pap test range from 15% to 30%.

Supportive Data

Studies have shown overall increased adequacy (as measured by decreased "unsatisfactory" and "satisfactory but limited by" rates) as compared to the conventional smear method. Some studies showing increased detection rates for epithelial cell abnormalities (low-grade squamous intraepithelial lesions and high-grade squamous intraepithelial lesions) as well as decreased indeterminate rates (atypical squamous cells of undetermined significance and atypical glandular cells of undetermined significance) have been reported in both split specimen (ThinPrep and conventional smears) and direct-to-vial comparison studies.

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

1. Austin RM, Ramzey I: Increased detection of epithelial cell abnormalities by liquid-based gynecologic cytology preparations. A review of accumulated data. Acta Cytol 1998;42:178-184

2. Guidos BJ, Selvaggi SM: Use of the ThinPrep Pap test in clinical practice. Diagn Cytopathol 1999;20:70-73

3. Kurman RJ, Solomon D: The Bethesda system for reporting cervical/vaginal cytologic diagnoses: definitions, criteria, and explanatory notes for terminology and specimen adequacy. New York, NY, Springer-Verlag, 1994

4. Gay JD, Donaldson LD, Goellner JR: False-negative results in cervical cytologic studies. Acta Cytol 1985;29:1043-1046

5. Saslow D, Solomon D, Lawson HW, et al: American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. J Low Genit Tract Dis 2012;16(3):175-204

Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test