NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Ascertaining whether ovulation occurred in a menstrual cycle
Evaluation of placental function in pregnancy
Workup of some patients with adrenal or testicular tumors
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Progesterone, S MMLNE only
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Preferred: Serum gel
Acceptable: Red top
Specimen Volume: 0.5 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild OK; Gross reject
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum||Refrigerated (preferred)||7 days|
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:
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.
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.
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.
Cord blood: 569-1,107 ng/mL*
0-23 months: 0.87-3.37 ng/mL*
2-9 years: <0.15 ng/mL*
10-17 years: adult levels are attained by puberty.*
> or =18 years: 0.20-1.40 ng/mL
Cord blood: 569-1,107 ng/mL*
0-23 months: 0.87-3.37 ng/mL*
2-9 years: 0.20-0.24 ng/mL*
10-17 years: values increase through puberty and adolescence.*
Follicular phase: 0.20-1.50 ng/mL
Ovulation phase: 0.80-3.00 ng/mL
Luteal phase: 1.70-27.00 ng/mL
Postmenopausal: <0.15-0.80 ng/mL
*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;85:782-787
Ovulation results in a mid-cycle surge of luteinizing hormone (LH) followed by an increase in progesterone secretion, with a peak being reached 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. A day 21 to 23 serum progesterone peak of 6.5 to 7 ng/mL is the minimal level considered consistent with ovulation. A level in excess of 18 ng/mL is considered conclusive proof of ovulation.
Placental insufficiency has been associated with low levels of LH and progesterone.
Levels of LH and progesterone may be increased in some adrenal or testicular tumors.
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.
In patients receiving therapy with high biotin doses (ie, >5 mg/day), no specimen should be drawn until at least 8 hours after the last biotin administration.
As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from specimens drawn from patients who have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes
In rare cases interference due to extremely high titers of antibodies to ruthenium and streptavidin can occur.
Clinical Reference Provides recommendations for further 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;85:782-787
2. Haymond S, Gronowski AM: In Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 4th edition. Edited by CA Burtis, ER Ashwood, DE Bruns. St. Louis, Elsevier, Inc, 2006, pp 2097-2152
Method Description Describes how the test is performed and provides a method-specific reference
Testing is performed on a Roche Cobas. The Roche Progesterone II assay is a competitive assay using electrochemiluminescence detection. Patient specimen, biotinylated monoclonal progesterone-specific antibody, and a progesterone derivative labeled with ruthenium complex are incubated with Danazol to release progesterone. Progesterone from the sample competes with the labeled progesterone derivative for the antibody binding site. After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. The amount of the labeled progesterone derivative bound to the solid phase is inversely proportional to the progesterone content of the sample. This reaction mixture is aspirated into measuring cell where the bound microparticles are 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 Cobas. Roche Diagnostics, Indianapolis, IN 09/2007)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Sunday; Continuously
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Same day/1 day
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
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 Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|