ThinPrep Pap Test Improves Screening Accuracy In 50,000 -- Patient Study
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ThinPrep Pap Test Improves Screening Accuracy In 50,000 -- Patient Study

BOSTON, MA -- November 5, 1997 -- A study of over 50,000 Australian patients presented today at the annual meeting of the American Society of Cytology found the ThinPrep(R) Pap Test(TM) significantly improved detection and clinical management of cervical abnormalities.

The study by Dr. Colin Laverty also found Cytyc Corporation's ThinPrep Pap Test substantially reduced the number of technically unsatisfactory samples requiring repeat tests. Results from the study were also published this week in the Medical Journal of Australia.

In this prospective study, split-sample, paired (conventional smear and ThinPrep Pap Test) slides were prepared from a single patient sample from 51,437 women undergoing routine Pap screening in Sydney, Australia between July 1996 and September 1997. In each case the conventional Pap smear was prepared first and the material remaining on the sampling device was then rinsed in the ThinPrep collection vial.

Although the conventional smear and ThinPrep Pap Test agreed in most cases, when the methods were discrepant, significantly more ThinPrep slides yielded a more severe diagnosis. With the addition of the ThinPrep Pap Test, 23.3 percent more women were recommended for colposcopic follow-up. For more severe levels of disease (high grade lesions), the addition of the ThinPrep Pap Test resulted in a 14 percent increase in biopsy confirmed cases.

The ThinPrep Pap Test was shown to demonstrate severe levels of the abnormality in 104 cases where the conventional smear missed the lesion, due to errors whether in preparation or screening of the conventional smear. In 74 of these cases the ThinPrep Pap Test contained cells of high grade lesions or suggestive of high grade lesions, but no such cells were found, even upon a second review, on the conventional smear.

These cases represent sampling errors. In the remaining 30 cases, the cells were missed on initial review of the conventional smear but detected on a second reading, representing screening errors. These results further document that a significant portion of false negative diagnoses is a result of sampling and preparation errors. The representative sampling and significantly improved slide quality provided by the ThinPrep Pap Test results in increased diagnostic confidence relative to the conventional Pap smear.

This study also demonstrated the adequacy of the specimen was improved with the ThinPrep Pap Test. Overall the ThinPrep Pap Test reduced the proportion of unsatisfactory slides by nearly 80 percent when compared to conventional Pap smears.

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