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New Test Update: Sensitive Estradiol Immunoassay
Background:
The Department of Pathology & Laboratory Medicine will replace the current estradiol assay (E2D) with a new sensitive estradiol immunoassay (E2D). The new assay reports precise estradiol levels between 20 - 5,200 pg/mL. Estradiol levels measure approximately 20% lower with the new assay. The reference intervals will be updated in accordance with the manufacturer’s instructions for use.

Estradiol reference intervals:
 
Previous reference interval Updated reference interval
Non-pregnant females:
   Early follicular phase None provided 22-115 pg/mL
   Mid follicular phase 27-122 pg/mL 25-115 pg/mL
   Ovulatory peak 95-433 pg/mL 32-517 pg/mL
   Mid luteal phase 49-291 pg/mL 37-246 pg/mL
   Postmenopausal 0-40 pg/mL <26 pg/mL
Males: 0-47 pg/mL <33 pg/mL

​​​​This test is suitable for measurement of estradiol in adult premenopausal women for rapid assessment of ovarian status, assisted reproduction protocols, or for establishing timing of ovulation and optimal conception. FOR EVALUATION OF ENDOGENOUS ESTROGEN STATUS IN PEDIATRIC PATIENTS, MALES, POSTMENOPAUSAL FEMALES, AND PATIENTS PRESCRIBED CERTAIN MEDICATIONS INCLUDING FULVESTRANT, THE RECOMMENDED METHODOLOGY IS LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY, WHICH IS A SEND OUT TEST (Lab test code: XESTRO).

Effective date: Aug. 28, 2019

Specimen requirement and testing information:

Specimen: Collect 5.0 mL blood in a gold top or light green top (lithium heparin) tube. Red top tubes also acceptable. Spin down and separate serum from cells within 2 hours of sample collection.

Test methodology: Chemiluminescent immunoassay

Test code: E2D

Stability:
Uncentrifuged whole blood:
Ambient: 2 hours
Refrigerated: 2 hours
Frozen: Unacceptable

Plasma, after centrifugation and aliquot separated from cells:
Ambient: N/A
Refrigerated: 2 weeks
Frozen: 1 month

Turnaround time (TAT):
STAT: 60 minutes
Routine: 2-4 hours
Set Up Days: Daily

Specimen required: 1.0 mL plasma
Minimum volume: 0.5 mL plasma

Rejection criteria:
Specimens that exceed stated stability, unlabeled/mislabeled/mismatched specimens, specimens submitted in leaking containers, hemolyzed or lipemic specimens.

Additional information:
FOR EVALUATION OF ENDOGENOUS ESTROGEN STATUS IN PEDIATRIC PATIENTS, MALES, POSTMENOPAUSAL FEMALES, AND PATIENTS PRESCRIBED CERTAIN MEDICATIONS INCLUDING FULVESTRANT, THE RECOMMENDED METHODOLOGY IS LIQUID CHROMATOGRAPHY-TANDEM MASS SPECTROMETRY, WHICH IS A SEND OUT TEST (Lab test code: XESTRO).

A summary of all tests offered by our laboratory services can be found here: http://www.pathology.uci.edu/services/index.asp

Sincerely,


Bridgit O. Crews, PhD, DABCC
Director
Clinical Chemistry & Toxicology

Edwin S. Monuki, MD, PhD
Chair
Department of Pathology & Laboratory Medicine
 
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