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Test Code UE3 Estriol, Unconjugated, Serum

Reporting Name

Estriol, Unconjugated, S

Useful For

As 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


Specimen Required


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 Type

Serum

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
  Frozen  90 days

Day(s) Performed

Monday through Friday

Seattle Children's Hospital Note:

TAT: 3 - 5 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Method Name

Immunoenzymatic Assay

Method Description

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)

Reference Values

Males: <0.07 ng/mL

Females: <0.08 ng/mL

 

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

Test Classification

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

82677

LOINC Code Information

Test ID Test Order Name Order LOINC Value
UE3 Estriol, Unconjugated, S 2250-9

 

Result ID Test Result Name Result LOINC Value
UE3 Estriol, Unconjugated, S 2250-9

Report Available

1 to 3 days

Reject Due To

Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK