PCOS Diagnostic Profile

CPT: 82397; 82627; 82670; 83001; 83002; 83498; 84146; 84270; 84402; 84403; 84443
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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

Serum must be separated from cells within 45 minutes of venipuncture. Send serum in a plastic transport tube.


Storage Instructions

Freeze.


Stability Requirements

Temperature

Period

Room temperature

1 day

Refrigerated

2 days

Frozen

70 days

Freeze/thaw cycles

Stable x3


Causes for Rejection

EDTA plasma; citrated plasma; hemolysis greater than 5%


Test Details


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.


Methodology

HPLC/tandem mass spectrometry (LC/MS-MS), Electrochemiluminescent (ECLIA), Immunochemiluminometric (ICMA), 2-site electrochemiluminescenceis


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


Footnotes

1. Rosner W, Auchus RJ, Azziz R, Sluss PM, Raff H. Position statement: Utility, limitations, and pitfalls in measuring testosterone: an Endocrine Society position statement. J Clin Endocrinol Metab. 2007 Feb;92(2):405-413.17090633
2. Centers for Disease Control and Prevention (CDC). PCOS (Polycystic ovary syndrome) and diabetes. CDC Web site. https://www.cdc.gov/diabetes/basics/pcos.html. Updated March 24 2020. Accessed July 1, 2021.
3. Teede HJ, Misso ML, Costello MF, et al. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Fertil Steril. 2018 Aug;110(3):364-379.30033227
4. Azziz R, Carmina E, Dewailly D, et al. The Androgen Excess and PCOS Society criteria for the polycystic ovary syndrome: the complete task force report. Fertil Steril. 2009 Feb;91(2):456-488.18950759
5. Ismail AA, Astley P, Burr WA, et al. The role of testosterone measurement in the investigation of androgen disorders. Ann Clin Biochem. 1986 Mar;23(Pt 2):113-134.3532913
6. Hunter MH, Sterrett JJ. Polycystic ovary syndrome: It's not just infertility. Am Fam Physician. 2000 Sep 1;62(5):1079-1088, 1090.1099753
7. Setji TL, Holland ND, Sanders LL, Pereira KC, Diehl AM, Brown AJ. Nonalcoholic steatohepatitis and nonalcoholic Fatty liver disease in young women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2006 May;91(5):1741-1747.16492691
8. Chang WY, Knochenhauer ES, Bartolucci AA, Azziz R. Phenotypic spectrum of polycystic ovary syndrome: Clinical and biochemical characterization of the three major clinical subgroups. Fertil Steril. 2005 Jun;83(6):1717-1723.15950641

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

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