Test Id : PGSN
Progesterone, Serum
    
        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.
                
            
    
    
    
        Reporting Name
            
                
                
                    
                    Lists a shorter or abbreviated version of the Published Name for a test
                
            
    
    
    
        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 and serum aliquoted into a plastic vial.
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 | |
| Ambient | 8 hours | ||
| Refrigerated | 72 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 https://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 801. 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 a 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
                
            
    
    
    
        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 Saturday
    
        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.
                
            
    
    
    
        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
            
                
                
                    
                    Indicates the location of the laboratory that performs the test
                
            
    
    
    
        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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        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.
                
            
    
    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 |