雅培全新肿瘤标志物临床应用新拓展.pptVIP

* The ROMA value is expressed as a percent, and is evaluated against a cutoff. On the right are the cutoffs for the combination of ARCHITECT CA125 and ARCHITECT HE4 assays. The cutoff for premenopausal women is 7.4%. If a women’s ROMA value is less than 7.4%, then she is at low risk of having ovarian cancer and her surgery can be performed by her gynecologist or general surgeon. If her ROMA value is 7.4% or greater, then she is a high risk of having ovarian cancer and she should be referred to a gynecological oncologist for evaluation. For postmenopausal women, the cutoff is 25.3%. It is important to note that the cutoff values will be different depending on which assay is being used to test the CA125 and HE4 values. For example, if an ARCHITECT CA125 assay value is combined with an HE4 assay value generated from the Fujirebio microtiter plate HE4 assay instead of the ARCHITECT HE4 assay, the cutoff for premenopausal women changes from 7.4% to 13.1%. Therefore it is important to know what assays are being used for the testing to properly evaluate the results. * Here is an example of a postmenopausal women with an ovarian mass. Her CA125 value is 55 U/mL and her HE4 value is 125 pmol/L. Since she is postmenopausal, the postmenopausal formula is used. Plug in the CA125 and HE4 values to get the predictive index, then plug that into the ROMA formula to get the ROMA score. In this case, the ROMA value is 46.6%. This is higher then the cutoff for postmenopausal women, so she has a high risk of having ovarian cancer. She should be referred to a gynecological oncologist. * Using ROMA to determine the risk of ovarian cancer in women with a pelvic mass was validated in a double blind multicenter trial in the US. 14 sites enrolled patients into this study. The eligibility criteria were 18 years or older, an ovarian cyst or pelvic mass confirmed via imaging, and to have a planned surgical intervention. All of the blood samples were obtained preoperatively and analyzed at the