PCOS Diagnostic Profile
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
Special Instructions
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.
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. Guidelines also recommend excluding thyroid disease (TSH), prolactin excess, and nonclassical congenital adrenal hyperplasia before diagnosing PCOS. Additionally, women should potentially be evaluated to rule out pregnancy, hypothalamic amenorrhea, primary ovarian insufficiency, androgen-secreting tumor, Cushing's syndrome, and acromegaly depending on clinical presentation.
Methodology
Mass Spectrometry
Biomarkers
LOINC Codes
- 3016-3
- 2986-8
- 15432-8
- 2991-8
- 10501-5
- 15067-2
- 2842-3
- 1668-3
- 2191-5
- 13967-5
- 35384-7
- 38476-8
Result Turnaround Time
7-10 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
9 mL
Minimum Volume
4 mL
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.
Storage Instructions
Freeze.
Causes for Rejection
EDTA plasma; citrated plasma; hemolysis greater than 5%
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 1 day |
| Refrigerated | 2 days |
| Frozen | 70 days |