Clinical performance of two multi-marker blood tests for predicting malignancy in women with an adnexal mass

Reliable methods that allow appropriate triage of women with an adnexal mass to a gynecologic oncologist are needed. We evaluated the clinical performance of OVA1 and ROMA for the prediction of malignancy in women with an adnexal mass.

One hundred forty-six prospectively collected serum samples were collected from women with an adnexal mass, 31 of whom had surgically confirmed malignancies. OVA1 and ROMA tests were performed on all samples. Receiver operating characteristic curve analysis was used to determine interpretive cutoffs for ROMA. Performance characteristics of both tests were determined and compared.

The sensitivity of OVA1 and ROMA was 97% and 87%, respectively (p=0.25). ROMA was more specific than OVA1 (83% vs. 55%, respectively; p<0.0001). The negative predictive values of both tests were similar (98.4% and 96.0%, respectively). ROMA performed on all patients identified as high risk by OVA1 (a sequential strategy) produced a positive predictive value of 69%.

OVA1 and ROMA have similar performance characteristics, with OVA1 having non-significant greater diagnostic sensitivity and ROMA having greater diagnostic specificity. The use of these tests to appropriately triage women with an adnexal mass should be gauged within the context of their respective limitations. A sequential testing strategy may improve overall performance.