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Test Code Billings Clinic: 9494 ASPiRA: VDS-100 OVA1, Serum

Performing Laboratory

ASPiRA Labs

Useful For

  • Useful for the assessment of malignancy risk in adnexal masses in patients planned for surgery
  • OVA1 has been FDA-cleared for use in women meeting the following requirements:
    • Are over 18 years of age
    • Have an ovarian adnexal mass
    • Have surgery planned
    • have not yet been referred to a gynecological oncologist
    • Have not had cancer in the past 5 years
    • Have a rheumatoid factor concentration < 250 IU/mL

 

Methodology

Biochemical

Specimen Requirements

  • Draw blood using the specimen collection tube contained in the OVA1 test kit (serum only)
  • Allow sample to completely clot prior to centrifugation
  • Spin down and send 2.5 mL of serum refrigerated in plastic vial

Reject Due To

  • Samples received other than serum
  • Serum specimens that are heat-inactivated
  • Serum specimens stabilized with azide
  • Specimens containing particulate or fibrin strands

Reference Values

An interpretive report will be provided.

  • The OVA1 test score is reported as a single numeric score on a scale of 1 to 10.
  • The cutoff threshold for a premenopausal patient is 5.0, and 4.4 for a post menopausal patient
  • Scores greater than or equal to these thresholds indicate a higher likelihood of malignancy.  Patients with a higher likelihood of malignancy may benefit from consultation with the gynecologic oncologist.

Day(s) Test Set Up

Monday through Friday

Test Classification and CPT Coding

81503 - Oncology (ovarian), biochemical assays of five proteins (CA-125, apolipoprotein A1, beta-2 macroglobulin, transferrin and pre-albumin), utilizing serum, algorithm reported as a risk score