Test Catalog

Test Id : UE3

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Estriol, Unconjugated, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

A part of second trimester or cross-trimester biochemical screening for Down syndrome and trisomy 18 syndrome

 

A marker of fetal demise

 

An adjunct biomarker in the prenatal diagnosis of disorders of fetal steroid metabolism, including Smith-Lemli-Opitz syndrome (1,2) and X-linked ichthyosis (placental sulfatase deficiency disorders)

 

Evaluating primary or secondary fetal adrenal insufficiency after excluding other rare single gene defects, including aromatase deficiency, 17 alpha-hydroxylase deficiency and/or various forms of congenital adrenal hyperplasia

Method Name
A short description of the method used to perform the test

Immunoenzymatic Assay

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Estriol, Unconjugated, S

Aliases
Lists additional common names for a test, as an aid in searching

E3 (Estriol)

Estriol

UE3 (Unconjugated Estriol)

Unconjugated Estriol

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 0.6 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.

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.

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject
Gross lipemia OK

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) 14 days
Frozen 90 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

A part of second trimester or cross-trimester biochemical screening for Down syndrome and trisomy 18 syndrome

 

A marker of fetal demise

 

An adjunct biomarker in the prenatal diagnosis of disorders of fetal steroid metabolism, including Smith-Lemli-Opitz syndrome (1,2) and X-linked ichthyosis (placental sulfatase deficiency disorders)

 

Evaluating primary or secondary fetal adrenal insufficiency after excluding other rare single gene defects, including aromatase deficiency, 17 alpha-hydroxylase deficiency and/or various forms of congenital adrenal hyperplasia

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Estrogens are involved in development and maintenance of the female phenotype, germ cell maturation, and pregnancy. There are 3 major biologically active estrogens in humans: estrone (E1), estradiol (E2), and estriol (E3). Like all members of the steroid hormone family, they diffuse into cells and bind to specific nuclear receptors, which in turn alter gene transcription in a tissue specific manner. E2 is the most potent natural human estrogen, closely followed by E1, while E3 possess only 20% of the E2 affinity for the estrogen receptor. In men and nonpregnant women, E1 and E2 are formed from the androgenic steroids, androstenedione and testosterone, respectively. E3 is derived largely through conversion of E2, and to a lesser degree from 16a-metabolites of E1. E2 and E1 can also be converted into each other, and both can be inactivated via hydroxylation and conjugation.

 

During pregnancy E3 becomes the dominant estrogen. The fetal adrenal gland secretes dehydroepiandrosterone-sulfate, which is converted to E3 in the placenta and diffuses into the maternal circulation. The half-life of unconjugated E3 (uE3) in the maternal blood system is 20 to 30 minutes since the maternal liver quickly conjugates E3 to make it more water soluble for urinary excretion. E3 levels increase throughout the course of pregnancy, peaking at term.

 

Decreased second trimester uE3 has been shown to be a marker for Down and trisomy-18 syndromes. uE3 is a part of multiple marker prenatal biochemical screening, together with alpha-fetoprotein, human chorionic gonadotropin, and inhibin-A measurements. Low levels of uE3 also have been associated with pregnancy loss, Smith-Lemli-Opitz syndrome (defect in cholesterol biosynthesis), X-linked ichthyosis and contiguous gene syndrome (placental sulfatase deficiency disorders), aromatase deficiency, and primary or secondary fetal adrenal insufficiency.

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.

Males: <0.07 ng/mL

Females: <0.08 ng/mL

 

For SI unit Reference Values, see www.mayocliniclabs.com/order-tests/si-unit-conversion.html

Interpretation
Provides information to assist in interpretation of the test results

In second trimester maternal serum screening (QUAD), unconjugated E3 (uE3) forms part of a complex, multivariate risk calculation formula, using maternal age, gestational stage, and other demographic information, in addition to the results of the biochemical markers, for Down syndrome and trisomy 18 risk calculation.

 

A serum uE3 <0.15 multiples of the gestational age median in women, who otherwise screen negative in the quad test, can indicate Smith-Lemli-Opitz syndrome and X-linked ichthyosis.

 

A low uE3 level can indicate the possibility of aromatase deficiency, congenital adrenal hyperplasia, primary or secondary (including maternal corticosteroid therapy) fetal adrenal insufficiency and/or fetal demise.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Like any immunoassay, this test can occasionally be subject to analytical interferences. Some patients who have been exposed to animal antigens, either in the environment or as part of treatment or imaging procedures, may have circulating anti-animal antibodies present. These antibodies may interfere with the assay reagents to produce unreliable results. If the clinical picture is inconsistent with the test results, clinicians should consider the possibility of a preanalytical or analytical error and contact the laboratory.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Bradley LA, Palomaki GE, Knight GJ, et al. Levels of unconjugated estriol and other maternal serum markers in pregnancies with Smith Lemli Opitz (RSH) syndrome fetuses [letter]. Am J Med Genet. 1999;82:355-358

2. Reisch N, Idkowiak J, Hughes B. Prenatal diagnosis of congenital adrenal hyperplasia caused by P450 oxidoreductase deficiency. J Clin Endocrinol Metab. 2013;98(3):E528-E536. doi:10.1210/jc.2012-3449

3. Thaniyaporn S, Chanane W, Supatra S, et al. Association between isolated abnormal levels of maternal serum unconjugated estriol in the second trimester and adverse pregnancy outcomes. J Matern Fetal Neonatal Med. 2016;29:13, 2093-2097

4. Minsart AF, Van Onderbergen A, Jacques F, et al. Indication of prenatal diagnosis in pregnancies complicated by undetectable second-trimester maternal serum estriol levels. J Prenat Med. 2008;2(3):27-30

5. Yarbrough ML, Stout M, Gronowski AM. Pregnancy and its disorders. In: Rifai N, Horvath AR, Wittwer CT, eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018:1655-1696

Method Description
Describes how the test is performed and provides a method-specific reference

The instrument used is the Beckman Coulter UniCel DxI 800. The Access unconjugated estriol assay is a competitive binding immunoenzymatic assay. A sample is added to a reaction vessel with estriol-alkaline phosphatase conjugate, paramagnetic particles coated with goat anti-rabbit IgG, and polyclonal rabbit anti-estriol. Estriol in the sample competes with estriol-alkaline phosphatase conjugate for a limited number of binding sites on the specific anti-estriol antibody. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then the chemiluminescent substrate Lumi-Phos 530 is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is inversely proportional to the concentration of estriol in the sample. The amount of analyte in the sample is determined by means of a stored, multipoint calibration curve.(Package Insert: Access Unconjugated Estriol Assay. Beckman Coulter, Inc; 2019)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

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 through 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.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

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.

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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 has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

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.

82677

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
UE3 Estriol, Unconjugated, S 2250-9
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.
UE3 Estriol, Unconjugated, S 2250-9

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports