Pap Imaging
Imaged Directed Pap Testing
The ThinPrep® Imaging System was approved for use by the FDA in 2003 to assist in primary cervical cancer screening for cancerous and pre-cancerous cells. The combination of the ThinPrep® Pap Test and the ThinPrep® Imaging System improves detection of abnormal cells and reduces false negative Pap tests.
Dual Review: Combining the Strengths of Human and Computerized Reviews
The ThinPrep® Imaging System combines computerized and human review of Pap test slides in a new class of imaging technology, called Dual Review™. With Dual Review, individual patient slides are first reviewed by the Imager, which scans every cell and cell cluster identifying areas of interest for further human review.
How the ThinPrep Imaging System Works
The ThinPrep Imaging System is an interactive computer system that assists cytotechnologists and pathologists in the primary screening of ThinPrep Pap Test slides. Pap tests are collected in a ThinPrep® Pap Test vial in the clinician’s office and then sent to the laboratory for processing on a ThinPrep processor. Slides are stained with a proprietary stain that eliminates variability for reproducible results. Similar to a Papanicalaou stain, the ThinPrep® stain is specially formulated for the Imager System.
The pre-formulated ThinPrep® stain reduces variability associated with mixing.
The Imager scans every cell and cell cluster on the patient’s slide, measuring the DNA content of the cells. The largest and darkest nuclei are identified by the Imager which may be an indicator of an abnormality requiring closer review.
This process highlights cells of interest for the cytotechnologist to review, thereby helping the cytotechnologist to better focus interpretive skills where it counts.
Improved Patient Outcomes
Using the ThinPrep Imaging System with Dual Review, accuracy compared to manual review is increased with a decrease in false negatives. In a recent study, Dr. Richard Lozano, MD, Director of Cytology at the Pathology and Cytology Laboratory in Lexington, Kentucky, compared the ThinPrep Imaging System with manually screened slides. The results showed that an imaging system with dual review technology successfully combines the best of modern computing power with the unique interpretive skills possessed by trained cytotechnologists and pathologists to increase disease detection. The results of his study demonstrated a statistically significant increase in HSIL detection. Dr. Lozano said, “We believe this technology will make a significant contribution to cervical cancer screening and patient management.”
Improved Patient Outcomes: Study results published by Dziura and colleagues show overall improved detection of cervical SIL compared to manual screening. Lozano found significantly increased detection of cervical abnormalities with dual review imaging compared with manual review alone. Miller found increases in disease detection along with a fifty percent reduction in the false negative fraction.
The standard of care in cytology screening is moving in the direction of a dual review system. Over 70% of Pap screening in the United States is performed with the ThinPrep Pap Test. Of these, more than half are imaged with the ThinPrep® Imaging System with Dual ReviewTM.
