Test Catalog

Test Id : ESTS

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Estradiol, Rapid, Immunoassay, Serum

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Overview

Test Catalog

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

Rapid assessment of ovarian status, including follicle development, for assisted reproduction protocols (eg, in vitro fertilization)

 

Establishing time of ovulation and optimal time for conception

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

Electrochemiluminescent Immunoassay

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

Estradiol Rapid, Immunoassay, S

Specimen Type
Describes the specimen type validated for testing

Serum

Ordering Guidance

This assay is for reproductive assessment (eg, IVF, conception). For other clinical indications, order EEST / Estradiol, Serum.

 

The preferred method for measurement of low serum estradiol concentrations in children, males, and postmenopausal females is liquid chromatography-tandem mass spectrometry (LC-MS/MS), order EEST / Estradiol, Serum.

 

This test should not be used when monitoring estradiol concentrations in patients being treated with Fulvestrant due to possible cross-reactivity. In these patients, estradiol concentrations should be measured using mass spectrometry; order EEST / Estradiol, Serum.

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

Patient Preparation: For 12 hours before specimen collection do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins.

Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions:

1. Serum gel tubes should be centrifuged within 2 hours of collection.

2. Red-top tubes should be centrifuged, and the serum aliquoted into a plastic vial within 2 hours of collection.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.4 mL

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

Gross hemolysis Reject
Gross lipemia OK
Gross icterus 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 Frozen (preferred) 180 days
Refrigerated 5 days
Ambient 24 hours

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

Rapid assessment of ovarian status, including follicle development, for assisted reproduction protocols (eg, in vitro fertilization)

 

Establishing time of ovulation and optimal time for conception

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

Estrogens are responsible for the development and maintenance of female sex organs and female secondary sex characteristics. In conjunction with progesterone, they participate in regulation of the menstrual cycle, breast and uterine growth, and in the maintenance of pregnancy.

 

Estrogens affect calcium homeostasis and have a beneficial effect on bone mass. They decrease bone resorption and, in prepubertal girls, estrogen accelerates linear bone growth. Long-term estrogen depletion is associated with loss of bone mineral content, an increase in stress fractures, and postmenopausal osteoporosis.

 

The 3 most biologically active estrogens in order of potency are estrone (E1), estradiol (E2), and estriol (E3). Estrogens are produced primarily in the ovary (follicle, corpus luteum), but small quantities are also formed in the testes and in the adrenal cortex. During pregnancy, estrogens are mainly formed in the placenta. About 98% of estradiol is bound to transport proteins (sex hormone-binding globulin) and albumin. Estrogen secretion is biphasic during the menstrual cycle.

 

The determination of E2 is utilized clinically in the elucidation of fertility disorders in the hypothalamus-pituitary-gonad axis, gynecomastia, estrogen-producing ovarian and testicular tumors, and in hyperplasia of the adrenal cortex. Additional clinical indications are the monitoring of fertility therapy and determining the time of ovulation within the framework of in vitro fertilization.

 

The laboratory plays an important role in the process of ovulation induction. The principle involves administration of gonadotropins to stimulate follicular growth, followed by human chorionic gonadotropin (hCG) to stimulate ovulation follicular maturation. Clinical, laboratory, and ultrasound monitoring of the treatment cycle is necessary to identify the dose and length of therapy, determine when or whether to administer hCG, and obtain an adequate ovulatory response while avoiding hyperstimulation.

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: 10-40 pg/mL

Females

Premenopausal: 15-350 pg/mL*

Postmenopausal: <10 pg/mL

*Estradiol concentrations vary widely throughout the menstrual cycle

Interpretation
Provides information to assist in interpretation of the test results

Optimal time for conception is within 48 to 72 hours following the midcycle estradiol peak. Serial specimens must be drawn over several days to evaluate baseline and peak estradiol levels. Low baseline levels and a lack of rise, as well as persistent high levels without midcycle rise, are indicative of anovulatory cycles.

 

For determining the timing of initiation of ovarian stimulation in in vitro fertilization (IVF) studies, low levels before stimulation are critical, as higher values often are associated with poor stimulation cycles. Before final human chorionic gonadotropin (hCG) stimulation at mid-IVF cycle, estradiol concentrations above 2000 to 3000 pg/mL are considered by some IVF specialists to be indicative of an increased likelihood of ovarian hyperstimulation and it may be advisable to consider withholding further hCG stimulation.

 

Estradiol (E2) concentrations below 200 pg/mL following midcycle stimulation (hCG or follicle-stimulating hormone [FSH]) are associated with very low pregnancy success rates.

 

E2 concentrations change during the menstrual cycle, as follows:

-less than 50 pg/mL before midfollicular phase

-250 to 500 pg/mL midcycle peak as the follicle matures

-Abrupt decrease after ovulation

-125 pg/mL peak during the luteal phase

 

Estrogen replacement in reproductive-age women should aim to mimic natural estrogen levels as closely as possible. E2 levels should be within the reference range for premenopausal women and luteinizing hormone and FSH should be within the normal range.

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

The limit of quantitation for estradiol measured by immunoassay is 25 pg/mL. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is the preferred method for measurement of low serum estradiol concentrations in children, males, and postmenopausal females (EEST / Estradiol, Serum).

 

For assays employing antibodies, the possibility exists for interference by human anti-animal antibodies (ie, heterophile antibodies) in the patient sample. Patients who have been regularly exposed to animals or have received immunotherapy or diagnostic procedures utilizing immunoglobulins or immunoglobulin fragments may produce antibodies (eg, human antimouse antibodies: HAMA) that interfere with immunoassays. This may falsely elevate or falsely decrease the results.

 

Interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin, or ruthenium can occur.

 

Fulvestrant is a member of a class of drugs called selective estrogen receptor degraders (SERDS). Due to the risk of cross-reactivity, the Roche Elecsys Estradiol assay should not be used when monitoring estradiol concentrations in patients being treated with Fulvestrant. In these patients, estradiol concentrations should be measured using mass spectrometry (EEST / Estradiol, Serum).

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

1. Rifai N, Chiu RWK, Young I, Burnham CAD, Wittwer CT, eds. Tietz Textbook of Laboratory Medicine. 7th ed. Elsevier; 2023

2. Practice Committee of the American Society for Reproductive Medicine. Ovarian hyperstimulation syndrome. Fertil Steril. 2008 Nov;90(5 Suppl):S188-S193

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

The Roche cobas e801 Estradiol III method is a competitive electrochemiluminescence immunoassay that employs a polyclonal antibody. Estradiol in the specimen reacts with an estradiol-specific biotinylated antibody forming an immunocomplex. Streptavidin-coated microparticles and an estradiol-derivative ruthenium complex are added, and the mixture becomes bound to the solid phase via interaction of biotin and streptavidin. The mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of voltage to the electrode induces the chemiluminescent emission, which is then measured.(Package insert: Elecsys Estradiol III. Roche Diagnostics; V6, 08/2020)

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 Sunday

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.

Same day/1 to 2 days

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

7 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.

82670

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
ESTS Estradiol Rapid, Immunoassay, S 2243-4
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.
ESTS Estradiol Rapid, Immunoassay, S 2243-4

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 | PHP Pdf | CMS 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