Test Details
Methodology
HPLC/tandem mass spectrometry (LC/MS-MS), Electrochemiluminescent (ECLIA), Immunochemiluminometric (ICMA), 2-site electrochemiluminescenceis
Result Turnaround Time
7 - 10 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Use
This panel is intended to aid physicians in diagnosing polycystic ovary syndrome (PCOS) by assessing biochemical hyperandrogenism and ruling out other disorders that mimic the clinical features of PCOS. This assay provides the sensitivity and specificity required for the assessment of the low testosterone levels found in women, children, adolescents, and hypogonadal men.1
Limitations
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Footnotes
Custom Additional Information
PCOS is the most common endocrine disorder in reproductive-aged women affecting more than 5 million women in the United States.2 Guidelines recommend a diagnosis of PCOS if two of the three following criteria are met: androgen excess, ovulatory dysfunction, or polycystic ovaries.
Measurement of total or free testosterone should be done using liquid chromatography-mass spectrometry (LCMS) assays. Guidelines also recommend excluding thyroid disease (TSH), prolactin excess (prolactin), and nonclassical congenital adrenal hyperplasia (17-OH progesterone) before diagnosing PCOS. Additionally, women should potentially be evaluated to rule out pregnancy, hypothalamic amenorrhea (HA), primary ovarian insufficiency, androgen-secreting tumor, Cushing's syndrome and acromegaly depending on clinical presentation.3,4
Once diagnosed, assessment and management of reproductive, metabolic and psychological features is vital to patient care. Many significant comorbidities are associated with PCOS, and additional testing for monitoring is recommended. Women with PCOS experience symptoms of androgen excess associated with PCOS, and additional testing for monitoring is recommended. Women with PCOS experience symptoms of androgen excess associated with menstrual abnormalities and infertility. Chronic anovulation experienced by patients with PCOS increases their risk of developing endometrial cancer. Women with PCOS are often overweight and are likely to suffer from insulin resistance, putting them at increased risk for developing type 2 diabetes mellitus and nonalcoholic steatohepatitis (NASH).5-7 Lipid abnormalities, including decreased high-density lipoprotein cholesterol levels and elevated triglyceride levels, as well as impaired fibrinolysis, are seen in women with PCOS.6,8 Cardiovascular disease is more prevalent, and women with PCOS have a significantly increased risk for myocardial infarction.6,8
Specimen Requirements
Specimen
Serum, frozen
Volume
9 mL
Minimum Volume
4 mL (Note: This volume does not allow for repeat testing.)
Container
Gel-barrier tube or red-top tube
Collection Instructions
Serum must be separated from cells within 45 minutes of venipuncture. Send serum in a plastic transport tube.
Stability Requirements
Temperature | Period |
---|---|
Room temperature | 1 day |
Refrigerated | 2 days |
Frozen | 70 days |
Freeze/thaw cycles | Stable x3 |
Storage Instructions
Freeze.
Causes for Rejection
EDTA plasma; citrated plasma; hemolysis greater than 5%
LOINC® Map
Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
---|---|---|---|---|---|---|
505550 | PCOS Diagnostic Profile | 500478 | TSH-ICMA | uU/mL | 3016-3 | |
505550 | PCOS Diagnostic Profile | 500160 | Testosterone, Total | ng/dL | 2986-8 | |
505550 | PCOS Diagnostic Profile | 500727 | % Free Testosterone (Dialysis) | % | 15432-8 | |
505550 | PCOS Diagnostic Profile | 500728 | Free Testosterone, Serum | pg/mL | 2991-8 | |
505550 | PCOS Diagnostic Profile | 500095 | Luteinizing Hormone (LH) ECL | mIU/mL | 10501-5 | |
505550 | PCOS Diagnostic Profile | 500098 | Follicle Stimulating Hormone | mIU/mL | 15067-2 | |
505550 | PCOS Diagnostic Profile | 500558 | Prolactin | ng/mL | 2842-3 | |
505550 | PCOS Diagnostic Profile | 500164 | 17-Alpha-Hydroxyprogesterone | ng/dL | 1668-3 | |
505550 | PCOS Diagnostic Profile | 503630 | DHEA-Sulfate, LCMS | ug/dL | 2191-5 | |
505550 | PCOS Diagnostic Profile | 500433 | Sex Hormone Binding Globulin | nmol/L | 13967-5 | |
505550 | PCOS Diagnostic Profile | 502608 | Estradiol, Serum, MS | pg/mL | 35384-7 | |
505550 | PCOS Diagnostic Profile | 500184 | Anti-Mullerian Hormone (AMH) | ng/mL | 38476-8 | |
Order Code | 505550 | |||||
Order Code Name | PCOS Diagnostic Profile | |||||
Order Loinc | ||||||
Result Code | 500478 | |||||
Result Code Name | TSH-ICMA | |||||
UofM | uU/mL | |||||
Result LOINC | 3016-3 | |||||
Order Code | 505550 | |||||
Order Code Name | PCOS Diagnostic Profile | |||||
Order Loinc | ||||||
Result Code | 500160 | |||||
Result Code Name | Testosterone, Total | |||||
UofM | ng/dL | |||||
Result LOINC | 2986-8 | |||||
Order Code | 505550 | |||||
Order Code Name | PCOS Diagnostic Profile | |||||
Order Loinc | ||||||
Result Code | 500727 | |||||
Result Code Name | % Free Testosterone (Dialysis) | |||||
UofM | % | |||||
Result LOINC | 15432-8 | |||||
Order Code | 505550 | |||||
Order Code Name | PCOS Diagnostic Profile | |||||
Order Loinc | ||||||
Result Code | 500728 | |||||
Result Code Name | Free Testosterone, Serum | |||||
UofM | pg/mL | |||||
Result LOINC | 2991-8 | |||||
Order Code | 505550 | |||||
Order Code Name | PCOS Diagnostic Profile | |||||
Order Loinc | ||||||
Result Code | 500095 | |||||
Result Code Name | Luteinizing Hormone (LH) ECL | |||||
UofM | mIU/mL | |||||
Result LOINC | 10501-5 | |||||
Order Code | 505550 | |||||
Order Code Name | PCOS Diagnostic Profile | |||||
Order Loinc | ||||||
Result Code | 500098 | |||||
Result Code Name | Follicle Stimulating Hormone | |||||
UofM | mIU/mL | |||||
Result LOINC | 15067-2 | |||||
Order Code | 505550 | |||||
Order Code Name | PCOS Diagnostic Profile | |||||
Order Loinc | ||||||
Result Code | 500558 | |||||
Result Code Name | Prolactin | |||||
UofM | ng/mL | |||||
Result LOINC | 2842-3 | |||||
Order Code | 505550 | |||||
Order Code Name | PCOS Diagnostic Profile | |||||
Order Loinc | ||||||
Result Code | 500164 | |||||
Result Code Name | 17-Alpha-Hydroxyprogesterone | |||||
UofM | ng/dL | |||||
Result LOINC | 1668-3 | |||||
Order Code | 505550 | |||||
Order Code Name | PCOS Diagnostic Profile | |||||
Order Loinc | ||||||
Result Code | 503630 | |||||
Result Code Name | DHEA-Sulfate, LCMS | |||||
UofM | ug/dL | |||||
Result LOINC | 2191-5 | |||||
Order Code | 505550 | |||||
Order Code Name | PCOS Diagnostic Profile | |||||
Order Loinc | ||||||
Result Code | 500433 | |||||
Result Code Name | Sex Hormone Binding Globulin | |||||
UofM | nmol/L | |||||
Result LOINC | 13967-5 | |||||
Order Code | 505550 | |||||
Order Code Name | PCOS Diagnostic Profile | |||||
Order Loinc | ||||||
Result Code | 502608 | |||||
Result Code Name | Estradiol, Serum, MS | |||||
UofM | pg/mL | |||||
Result LOINC | 35384-7 | |||||
Order Code | 505550 | |||||
Order Code Name | PCOS Diagnostic Profile | |||||
Order Loinc | ||||||
Result Code | 500184 | |||||
Result Code Name | Anti-Mullerian Hormone (AMH) | |||||
UofM | ng/mL | |||||
Result LOINC | 38476-8 |