PCOS Diagnostic Profile

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

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

Specimen Requirements

Information on collection, storage, and volume

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

Storage Instructions

Freeze.

Causes for Rejection

EDTA plasma; citrated plasma; hemolysis greater than 5%

Collection

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