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HelpTest Code ESTS Estradiol, Rapid, Immunoassay, Serum
Reporting Name
Estradiol Rapid, Immunoassay, SUseful For
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
Electrochemiluminescent Immunoassay (ECLIA)
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Specimen Type
SerumOrdering 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
Patient Preparation: For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 0.5 mL
Collection Instructions: Within 2 hours of collection, centrifuge and aliquot serum into a plastic vial.
Specimen Minimum Volume
0.4 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Frozen (preferred) | 180 days | |
| Refrigerated | 5 days | ||
| Ambient | 24 hours |
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | OK |
| Gross icterus | OK |
Reference Values
Males: 10-40 pg/mL
Females
Premenopausal: 15-350 pg/mL*
Postmenopausal: <10 pg/mL
*Estradiol concentrations vary widely throughout the menstrual cycle
Day(s) Performed
Monday through Sunday
CPT Code Information
82670
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| ESTS | Estradiol Rapid, Immunoassay, S | 2243-4 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| ESTS | Estradiol Rapid, Immunoassay, S | 2243-4 |
Clinical Information
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, estradiol (E2), and estriol. 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.
Interpretation
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.
Estradiol 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
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. 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
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;90(5 Suppl):S188-S193
Method Description
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; V5.0, 10/2022)