Test Catalog

Test Id : PGSN

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Progesterone, Serum

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Overview

Test Catalog

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

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

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

Electrochemiluminescence Immunoassay (ECLIA)

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

Progesterone, S

Specimen Type
Describes the specimen type validated for testing

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, 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: 1 mL

Collection Instructions:

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

2. Red-top tubes should be centrifuged, and 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. The minimum volume is sufficient for one attempt at testing.

0.5 mL

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

Gross hemolysis Reject
Gross lipemia 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 72 hours
Ambient 8 hours

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

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

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

Sources of progesterone are the adrenal glands, corpus luteum, and placenta.

 

Adrenal Glands:

Progesterone synthesized in the adrenal glands is converted to other corticosteroids and androgens and, thus, is not a major contributor to circulating serum levels unless there is a progesterone-producing tumor present.

 

Corpus Luteum:

After ovulation, there is a significant rise in serum levels as the corpus luteum begins to produce progesterone in increasing amounts. This causes changes in the uterus, preparing it for implantation of a fertilized egg. If implantation occurs, the trophoblast begins to secrete human chorionic gonadotropin, which maintains the corpus luteum and its secretion of progesterone. If there is no implantation, the corpus luteum degenerates and circulating progesterone levels decrease rapidly, reaching follicular phase levels about 4 days before the next menstrual period.

 

Placenta:

By the end of the first trimester, the placenta becomes the primary secretor of progesterone.

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.

<4 weeks: Not established

4 weeks-<12 months: < or =0.66 ng/mL (Confidence Interval: 0.63-0.94 ng/mL)

12 months-9 years: < or =0.35 ng/mL

10-17 years: Concentrations increase through adolescence and puberty

> or = 18 years: <0.20 ng/mL

Reference intervals are central 90th percentile of healthy population

 

Females:

<4 days old: Not established

4 days-<12 months: < or =1.3 ng/mL (Confidence Interval: 0.88-2.3 ng/mL)

12 months-9 years: < or =0.35 ng/mL

10-17 years: Adult concentrations are attained by puberty

> or = 18 years:

Reference intervals are central 90th percentile of healthy population

-Follicular phase: < or =0.89 ng/mL

-Ovulation: < or =12 ng/mL

-Luteal phase: 1.8-24 ng/mL

-Post-menopausal: < or =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. https://caliperproject.ca/caliper/database/

 

For International System of Units (SI) conversion for Reference Values, see www.mayocliniclabs.com/order-tests/si-unit-conversion.html.

Interpretation
Provides information to assist in interpretation of the test results

Ovulation results in a midcycle surge of luteinizing hormone followed by an increase in progesterone secretion, peaking between day 21 and 23. If no fertilization and implantation has occurred by then, supplying the corpus luteum with human chorionic gonadotropin-driven growth stimulus, progesterone secretion falls, ultimately triggering menstruation. Typically, day 21 to 23 serum progesterone concentrations of more than 10 ng/mL indicate normal ovulation and concentrations below 10 ng/mL suggest anovulation, inadequate luteal phase progesterone production, or inappropriate timing of specimen collection.

 

Increased progesterone concentrations are occasionally seen with some ovarian cysts, molar pregnancies, rare forms of ovarian cancer, adrenal cancer, congenital adrenal hyperplasia, and testicular tumors. Increased progesterone may also be a result of overproduction by the adrenal glands.

 

Low concentrations of progesterone may be associated with toxemia in late pregnancy, decreased ovarian function, amenorrhea, ectopic pregnancy, and miscarriage.

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

Assessment of the function of the corpus luteum requires correlation with the phase of the menstrual cycle.

 

Taking estrogen and progesterone supplements can affect results.

 

As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from specimens collected from patients who have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes.

 

In rare cases, interference can occur due to extremely high titers of antibodies to ruthenium and streptavidin.

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

1. Lippe BM, LaFranchi SH, Lavin N, et al. Serum 17-alpha-hydroxyprogesterone, progesterone, estradiol, and testosterone in the diagnosis and management of congenital adrenal hyperplasia. J Pediatr. 1974;85(6):782-7. doi:10.1016/s0022-3476(74)80340-9

2. Haymond S, Gronowski AM. In Burtis CA, Ashwood ER, Bruns DE, eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 4th ed. Elsevier; 2006: 2097-2152

3. CALIPER Database. The Hospital for Sick Children. Available at: https://caliperproject.ca/caliper/database/

4. Cole T. Hormones. In: Rifai N, Chiu RWK, Young I, Burnham CA, Wittwer CT, eds. Tietz Textbook of Laboratory Medicine. 7th ed. Elsevier; 2023:chap 38

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

Testing is performed using the Roche Cobas e801. 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: Elecsys Progesterone III. Roche Diagnostics; V4, 10/2022)

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 day

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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  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

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.

84144

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
PGSN Progesterone, S 83109-9
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.
PGSN Progesterone, S 83109-9

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 | 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