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Test ID OVAPA Ovarian Malignancy Risk Assessment, Ova1Plus, Serum


Ordering Guidance


This test is intended for individuals with a detected pelvic mass and supportive evidence suggests surgical management.



Shipping Instructions


1. Specimens sent refrigerated must reach Mayo Clinic Laboratories within 4 days of collection.

2. Specimens sent frozen must be shipped on dry ice.



Specimen Required


Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 2 mL Serum

Collection Information:

1. Allow the specimen to clot for at least 30 minutes.

2. Within 2 hours of collection, centrifuge the specimen.

3. For serum gel tubes, aliquot serum into a plastic vial or send centrifuged serum gel tube.

4. For red top tubes, aliquot serum into a plastic vial within 10 minutes of centrifugation.


Useful For

Risk assessment for ovarian malignancy in women who present with an adnexal mass and are indicated for surgical management

Highlights

Ova1Plus is a non-invasive blood test that combines two US Food and Drug Administration-cleared tests (Ova1 [high sensitivity] and Overa [high specificity]) for women with adnexal masses planned for surgery.

 

Ova1 is a multivariate index assay combining results from five tests: CA-125 II, prealbumin, apolipoprotein A1, beta2-microglobulin, and transferrin into a single-valued index between 0 and 10; a higher value corresponds to a higher risk of malignancy.

 

Overa is a second-generation multivariate index assay that seeks to improve the specificity of the Ova1 by looking at three markers (CA-125 II, transferrin, and apolipoprotein A1) and two new biomarkers (follicle-stimulating hormone and human epididymis protein 4).

Testing Algorithm

Ova1Plus is comprised of two separate tests, Ova1 and Overa. The Ova1 test is always performed. The Overa test is performed reflexively only when an intermediate risk is determined from Ova1.

 

For more information see Clinical Triage for Adnexal Masses

Method Name

Immunoassay/Multivariate Index Assay/Electrochemiluminescence Immunoassay (ECLIA)

Reporting Name

Ova1Plus, S

Specimen Type

Serum

Specimen Minimum Volume

Serum: 1.5 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 8 days
  Frozen  90 days

Reference Values

An interpretive report will be provided.

Day(s) Performed

Monday, Wednesday, Friday

Report Available

5 days

Performing Laboratory

Aspira Labs, Inc.

Test Classification

This test was developed and its performance characteristics determined by Aspira Labs, a wholly owned subsidiary of Aspira Women's Health. The laboratory is regulated under CLIA as qualified to perform high-complexity testing. Before making any treatment decisions, all women should discuss the results with their healthcare provider, who can recommend follow up testing or procedures when appropriate. Ova1 Plus is a reflex process which performs Ova1 and Overa, both independently FDA-cleared tests for women with adnexal masses.

CPT Code Information

81503

0003U

LOINC Code Information

Test ID Test Order Name Order LOINC Value
OVAPA Ova1Plus, S Not Provided

 

Result ID Test Result Name Result LOINC Value
OVA1P Ova1Plus Not Provided

NY State Approved

Yes