mtm’s p16/Ki-67 dual immuno-staining identifies high-grade cervical disease in ASC-US and LSIL with high sensitivity and specificity
The EEMAPS study used the advanced biomarker combination CINtec® PLUS, which was launched by mtm in early 2010 in Europe. Residual materials from a previous pan-European retrospective cytology study were used to prepare additional slides for p16 and Ki-67 dual immuno-staining. In total, 361 ASC-US and 415 LSIL cases with corresponding biopsy results and HPV test results were available for dual stain cytology analysis. The presence of one or more dual-stained cervical epithelial cell(s) defined a positive test result with CINtec® PLUS, independent from morphology interpretation. The clinical results showed that the sensitivity of the dual stain for high-grade disease was 92.2% (71/77) for ASC-US, and 94.2% (129/137) for LSIL cases, which is equivalent to the sensitivity results obtained for HPV testing. However, specificity was significantly higher for CINtec® PLUS as compared to HPV testing; 80.6% vs. 36.3% for ASC-US and 68.0% vs. 19.1% for LSIL.
“mtm’s CINtec® PLUS is the first test that provides high sensitivity and high specificity for underlying high-grade cervical disease in a single product, irrespective of women’s age and the individual HR-HPV genotype,” commented Bob Silverman, CEO of mtm laboratories. “Because the test can pinpoint which women are most likely to have cervical disease and need follow up, this should reduce a large number of the unnecessary, uncomfortable and costly colposcopies carried out on women with ASC-US or LSIL.”
ASC-US and LSIL are definitions for equivocal and mild to moderate abnormal cytology findings on Pap tests, and may represent 5-8% of all cervical cytology cases. While most of these findings are negative for high-grade disease, 15-20% of LSIL and 6-10% of ASC-US will harbour high-grade disease. Together, these two categories of cytology represent the source for about 60% of all cases of high-grade cervical disease in women. Unfortunately, these Pap cytology results are not adequate predictors in determining which ASC-US or LSIL cases require intervention due to the low rates of underlying disease. Adjunctive HPV testing also has limitations due to unsatisfactory specificity.
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