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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 United States. It was developed to address the limitations of the conventional Pap smear. The ThinPrep Pap Test was approved in May 1996 by the U.S. Food and Drug Administration (FDA) after rigorous clinical trials, as a replacement for the conventional Pap smear. Requisition form

Since FDA approval, many 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 has been using this innovative screening system since 2004.

 

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 FDA-approved APTIMA HPV Assay, in vitro nucleic acid

amplification tests to detect high-risk HPV types. The APTIMA HPV screening assay detects 14high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51,52, 56, 58, 59, 66 and 68). The APTIMA 16, 18/45 assay can be added to Pap tests which are found to be positive by the screening assay. The APTIMA 16, 18/45 assay allows specific detection of HPV types 16 and/or HPV types 18/45. HPV types 16, 18, and 45 are associated with the majority of invasive carcinomas of the cervix. The APTIMA 16, 18/45 assay may aid in identifying women who are at increased risk of a high-grade squamous intraepithelial lesion (HSIL) or invasive carcinoma; and the detection of HPV 16, 18, or 45 may change diagnostic workup for some women.

 

When completing the Pathology Consultants Gyn requisition form, the clinician may choose to order HPV testing with the Pap test regardless of the Pap test result (Pap test and HPV co-test), reflex HPV testing if the Pap test is ASCUS, or HPV testing without a Pap test evaluation. The desired HPV option must be selected and marked on the GYN requisition form for the testing to be performed. The GYN requisition form has several options, which are separated by patient age. The preferred age-specific method of testing per the Updated Consensus Guidelines for Managing Abnormal Cervical Cancer Screening Tests and Cancer Precursors published by the American Society for Colposcopy and Cervical Pathology (ASCCP) are indicated as such on the requisition form to aid in HPV testing selection.

 

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.

 

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