Test Id : OVAPA
Ovarian Malignancy Risk Assessment, Ova1Plus, Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
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
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
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
A short description of the method used to perform the test
Immunoassay/Multivariate Index Assay/Electrochemiluminescence Immunoassay (ECLIA)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Multivariate Index Assay
Immunoassay
CA-125 II
Prealbumin
Apolipoprotein A-1
Beta2-microglobulin
Transferrin
Follicle Stimulating Hormone
Human Epididymis Protein 4
Aspira
Aspira Women's Health
Ova1
Overa
Adnexal Masses
Menopause
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
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
Specimen Type
Describes the specimen type validated for testing
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.
ORDER QUESTIONS AND ANSWERS
| Question ID | Description | Answers |
|---|---|---|
| OVAP1 | Menopausal Status |
Pre Post Unknown Unable to Provide |
| OVAP2 | Ultrasound Results |
High Risk Low Risk Unknown Unable to Provide |
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
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.
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
Serum: 1.5 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
| Gross lipemia | Reject |
| Gross icterus | Reject |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 8 days | |
| Frozen | 90 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Risk assessment for ovarian malignancy in women who present with an adnexal mass and are indicated for surgical management
Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.
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
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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. Results in the normal range may suggest a low risk for ovarian cancer. Epithelial cell tumors make up an average of 75% of all ovarian cancer tumor types, including serous, mucinous, endometrioid, clear cell, and Brenner tumors.
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.
An interpretive report will be provided.
Interpretation
Provides information to assist in interpretation of the test results
Low risk Ova1 results indicate a low risk of malignancy. A low-risk value has been determined to have a negative predictive value of 98%.
Elevated risk Overa results predict a risk of malignancy when combined with ultrasound results. Results should be interpreted along with clinical and ultrasound assessment.
High-risk imaging was defined as any complex ovarian tumor with evidence of solid or papillary components.
Low risk imaging was defined as unilocular or septate cystic ovarian tumor without high-risk findings.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Results cannot be interpreted as absolute evidence of the presence or absence of malignant disease and should always be interpreted in combination with clinical assessment.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. Bristow RE, Smith A, Zhang Z, et al. Ovarian malignancy risk stratification of the adnexal mass using a multivariate index assay. Gynecol Oncol. 2013;128(2):252-259
2. Goodrich ST, Bristow RE, Santoso JT, et al. The effect of ovarian imaging on the clinical interpretation of a multivariate index assay. Am J Obstet Gynecol. 2014;211(1):65.e1-65.e11
Method Description
Describes how the test is performed and provides a method-specific reference
Ova1Plus is a reflex process that incorporates both Ova1 and Overa; in cases of an intermediate Ova1 result, the Overa reflex is performed to increase specificity. Both Ova1 and Overa are qualitative serum tests that generate a single numerical score by applying an algorithm to five immunoassay results. For Ova1, the biomarkers measured are CA-125 II, prealbumin, apolipoprotein A-1, beta-2 microglobulin, and transferrin. For Overa, the biomarkers are follicle-stimulating hormone (FSH), human epididymis protein 4 (HE4), apolipoprotein A-1, transferrin, and CA-125 II. All biomarker values are determined using assays on the Roche cobas, an automated analyzer which uses electrochemiluminescence detection. The biomarker assays are conducted according to the manufacturer's directions as detailed in the Instructions for Use for each product.
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday, Wednesday, Friday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their account representative. For assistance, contact Customer Service.
Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
81503
| 0003U |
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| OVAPA | Ova1Plus, S | Not Provided |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| OVA1P | Ova1plus | Not Provided |