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Test Code PROGESTERO Progesterone, Serum

Reporting Name

Progesterone, S

Useful For

Ascertaining whether ovulation occurred in a menstrual cycle

 

Assessment of infertility

 

Evaluation of abnormal uterine bleeding

 

Evaluation of placental health in high-risk pregnancy

 

Determining the effectiveness of progesterone injections when administered to women to help support early pregnancy

 

Workup of some patients with adrenal disorders


Specimen Required


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

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 1 mL

Collection Instructions:

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

2. Red-top tubes should be centrifuged and aliquoted within 2 hours of collection.


Seattle Children's Hospital Note:

Collect 2.0 mL whole blood in a Red top.

 

Specimen Type

Serum

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Frozen (preferred) 180 days
  Refrigerated  72 hours
  Ambient  8 hours

Day(s) and Time(s) Performed

Monday through Sunday; Continuously

Performing Laboratory

Mayo Medical Laboratories in Rochester

Method Name

Electrochemiluminescence Immunoassay

Method Description

Testing is performed using the Roche Cobas e601/602. The Roche Progesterone III assay is a competitive immunoassay using electrochemiluminescence detection. Patient specimen and biotinylated progesterone-specific antibody are incubated to produce immunocomplexes. The amount of immunocomplexes formed is dependent on the progesterone concentration in the sample. Then, streptavidin-coated microparticles and a progesterone derivative labeled with a ruthenium complex are added to the reaction mixture and occupy the open sites still present on the biotinylated antibodies by formation of an antibody-hapten complex. The entire complex becomes bound to the solid phase via interaction of biotin and streptavidin. Next, the reaction mixture is aspirated into measuring cell where the bound microparticles are magnetically captured onto the electrode surface and unbound substances are removed. Voltage is applied to the electrode inducing a chemiluminescent emission which is then measured against a calibration curve to determine the amount of progesterone in the patient specimen.(Package insert: Roche Progesterone III. Roche Diagnostics, Indianapolis, IN)

Reference Values

Males:

<4 weeks: Not established

4 weeks-<12 months: ≤0.66 ng/mL (confidence interval 0.63-0.94 ng/mL)

12 months-9 years: ≤0.35 ng/mL

10-17 years:

-Concentrations increase through adolescence and puberty

-12 months-9 years: ≤0.35 ng/mL

-≥18 years (central 90th %): <0.20 ng/mL

≥18 year:

<0.20 ng/mL (Reference intervals are central 90th % of healthy population)

 

Females:          

<4 days old: Not established

4 days-<12 months: ≤1.3 ng/mL (confidence interval 0.88-2.3 ng/mL)

12 months-9 years: ≤0.35 ng/mL

10-17 years:

-Adult concentrations are attained by puberty

-12 months-9 years: ≤0.35 ng/mL

-Adult (central 90th %):

 - Follicular phase: ≤0.89 ng/mL

 - Ovulation: ≤12 ng/mL

 - Luteal phase: 1.8-24 ng/mL

  -  Pregnancy

   -   1st trimester: 11-44 ng/mL

   -   2nd trimester: 25-83 ng/mL

   -   3rd trimester: 58-214 ng/mL

≥18 years: 

-Reference intervals are central 90th % of healthy population

-Follicular phase: ≤0.89 ng/mL

-Ovulation: ≤12 ng/mL

-Luteal phase: 1.8-24 ng/mL

-Post-menopausal: ≤0.20 ng/mL

-Pregnancy

 - 1st trimester: 11-44 ng/mL

 - 2nd trimester: 25-83 ng/mL

 - 3rd trimester: 58-214 ng/mL

 

Pediatric reference intervals adopted from the CALIPER study. www.sickkids.ca/caliperproject/index.html The Hospital for Sick Children. Toronto, Canada.

Test Classification

This test has been cleared or approved by the U.S. 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

84144

LOINC Code Information

Test ID Test Order Name Order LOINC Value
PGSN Progesterone, S 83109-9

 

Result ID Test Result Name Result LOINC Value
PGSN Progesterone, S 83109-9

Reject Due To

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross OK

Icterus

NA

Other

NA