Intended Use for OVA1:
The OVA1 Test is a qualitative serum test that combines the results of five immunoassays into a single numerical result. It is indicated for women who meet the following criteria: over age 18 years, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
OVA1 Test Value
Interpretive Criteria for Probability of Malignancy
Premenopausal <5.0 > = 5.0
Postmenopausal <4.4 > = 4.4
The OVA1 Test is based on a proprietary FDA-cleared software device that combines into a single numerical result; the results of Beta-2 microglobulin, Transferrin, Transthyretin, Apolipoprotein A1 and CA 125 II (Roche Elecsys). These tests should be ordered independently if clinically indicated. The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy.
Precaution and Selected Limitations for OVA1:
The OVA1 Test should not be used without an independent clinical/radiological evaluation and is not intended as a screening test or to determine whether a patient should proceed to surgery. Incorrect use of the OVA1 Test carries the risk of unnecessary testing, surgery and/or delayed diagnosis.
-A negative OVA1 Test result, in the setting of a position pre-surgical assessment, should not preclude oncology referral.
-The OVA1 Test is not indicated for patients with a diagnosis of a malignancy within the last 4 years.
-Patients with elevated rheumatoid factor, . or = 250 IU/mL, should not be tested for OVA1 Test.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
Reference: OVA1 Test Product Insert, Vermillion, Inc., Freemont, CA. January 27, 2010.