NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
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 physicianâ€™s independent clinical and radiological evaluation does not indicate malignancy.
Fixed Rate Time Nephelometry
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Draw blood in a plain red-top tube(s). (Serum gel tube is acceptable.) Spin down and submit 2.2 mL of serum frozen in a plastic vial.
Note: OVA1 Test is not to be used if patient is known to have rheumatoid factor of > or = 250 IU/L. Triglycerides above 450 mg/dL may interfere with the assay and should not be used. The test is not indicated for patients with diagnosis of malignancy within the last 5 years.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum||Frozen (preferred)||63 days|
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 physicianâ€™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.
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Saturday
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
3 - 5 days
Performing Laboratory Location The location of the laboratory that performs the test
Quest Diagnostics Nichols Institute
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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|