Other Services
ThinPrep Pap Test
ThinPrep Imaging System
HPV testing
Nongynecologic Cytology
ThinPrep Pap Test: The ThinPrep Pap Test is the most widely used method for cervical cancer screening in the
Since FDA approval, more than 170 studies have been published, in peer-reviewed medical journals, demonstrating a wide range of clinical benefits of the ThinPrep Pap Test including increased disease detection, reduction of ASCUS diagnoses, improved specimen adequacy, cost effectiveness and the ability to perform human papillomavirus (HPV) testing out of the same vial.
The ThinPrep Pap Test is the only replacement to the conventional Pap smear that has Food & Drug Administration (FDA) labeling claims stating that the ThinPrep is significantly more effective than the conventional Pap smear for the detection of low-grade squamous intraepithelial (LSIL) and more severe lesions in a variety of patient populations.
The Thin Prep Pap test is very easy to implement in your practice. Patient samples are collected the same as with a conventional Pap smear; however, the collection device is rinsed into a vial of preservative solution instead of being smeared on a slide. At the laboratory, the ThinPrep process disperses and filters the sample to produce a more representative patient sample with less obscuring material.
ThinPrep® Imaging System: The ThinPrep Imaging System was approved for use by the Food and Drug Administration (FDA) in 2003 to assist in primary cervical cancer screening for cancerous and pre-cancerous cells. Pathology Consultants was the first laboratory in the upper
ThinPrep Imaging is the first system to provide Dual Review™ whereby both the Imager and Cytotechnologist review every slide. It is also the first system that scans every cell and cell cluster and identifies areas of interest for further review by the Cytotechnologist, which allows the Cytotechnologist to better focus his or her interpretive skills on these defined areas. Since its introduction in 2003, a growing number of laboratories have adopted the ThinPrep Imaging System.
The ThinPrep Imaging System is designed to reduce false negative test results and human error. In addition, the combination of the ThinPrep Pap Test and the ThinPrep Imaging System provides a more accurate diagnosis. The process achieves a higher level of certainty in cervical screening and improves diagnostic capability for greater accuracy. This dual screening approach improves the specificity of HSIL diagnoses, while not losing sensitivity for LSIL, HSIL or other diagnoses, while further reducing the rate of false negatives (39% reduction in false negatives).
HPV testing: Pathology Consultants uses the Digene Hybrid Capture 2 assay for the detection of high and low risk HPV types. The Digene HPV test can differentiate between two groups; low risk (6, 11, 42, 43 and 44) and high/intermediate risk (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68) HPV subtypes, but can not determine the specific HPV type(s) present.
Low risk serotypes 6 and 11 cause predominately genital warts/condyloma acuminate and are only rarely associated with high grade squamous intraepithelial lesions (HSIL) or invasive carcinomas. High risk serotypes can be associated with the development of HSIL and invasive carcinomas.
In a patient with an ASCUS Pap test, the sensitivity of the Digene HPV test is 93% with a specificity of 61.1%. The Positive Predictive Value is 17.2% and the Negative Predictive Value is 99.0%. 10-30% of women with HPV detectable by DNA assays will have microscopic abnormalities diagnosed. False positive assay results can be due to technique/analytical issues, but are not due to blood, douche, antifungal cream or contraceptive jelly. Negative assay results do not rule out the presence of HPV; the false negative rate of the test has been estimated to be between 1.1 and 7.5% as very low levels of infection or sampling bias may cause a false negative result.
The use of the Digene HPV test is suggested to screen patients with ASCUS Pap test results to determine the need for referral colposcopy. According to the 2001 consensus Guidelines for the Management of Women with Cervical Cytological Abnormalities, HPV testing is the preferred approach for managing patients with ASCUS results.
When completing the Pathology Consultants Gyn requisition form, the clinician may select the option to order reflex HPV testing. An HPV option (High Risk HPV type or High and Low Risk HPV types) must be selected and marked on the Gyn requisition form for the testing to be performed. If a clinician wishes to order the HPV test as an add-on, it may be added through our electronic order entry system or by calling Pathology Consultants, P.C. at 701-222-2480 (1-800-659-0395) within 21 days of sample collection.
A clinician may order HPV testing with the ThinPrep regardless of the Pap Test result. In 2003, the FDA approved the use of the HPV DNA testing in women 30 and older for primary cervical cancer screening. Expanded testing (consisting of both Pap and HPV DNA tests) provides more targeted screening by identifying women who have an increased risk of cervical cancer. Women with HPV in their cervical cells require more diligent follow-up as long as the virus persists—even when their Pap Test result is negative. Due to low sensitivity on any single test, the Pap requires frequent retesting. The combination of a Pap and a HPV test is more sensitive than a Pap alone and identifies women who possibly have long-term persistent infection or disease missed by the Pap. Women who test negative on both the HPV and Pap Test have virtually no risk of cervical cancer over the next few years and may safely widen their screening interval. The frequency of testing can be individualized based on a woman’s screening history, age at first intercourse, HPV status (if known), age and perception of risk.
Nongynecologic Cytology: Pathology Consultants uses ThinPrep technology for processing a wide variety of body fluid and fine-needle clinical specimens from non-gynecologic sites. Requisition form
