TEST DIRECTORY... | MIDx Labs

- PROFILE - FEMALE HORMONE

The Female Hormone Profile provides a structured assessment of the hypothalamic-pituitary-ovarian axis together with the adrenal androgens and pituitary hormones that most often account for an abnormal result. FSH, LH, and estradiol characterize ovarian function and pituitary drive, and their pattern distinguishes ovarian insufficiency from hypothalamic and pituitary causes of menstrual disturbance. Progesterone confirms ovulation when collected in the luteal phase. Prolactin is included because hyperprolactinemia is a common and treatable cause of oligomenorrhea, amenorrhea, and infertility.

Androgen status is assessed through total testosterone with SHBG, permitting calculation of free testosterone, alongside DHEA-S as a marker of adrenal androgen output. Morning cortisol provides an initial assessment of adrenal function.

Intended for the evaluation of menstrual irregularity, amenorrhea, infertility, hirsutism or other signs of androgen excess, suspected polycystic ovary syndrome, and suspected perimenopausal transition. Every reproductive hormone in this profile is cycle dependent, and the profile is interpretable only in reference to a declared collection window. Review the Patient Preparation section before scheduling.

LIS PROFILE CODE: (MID) Female Hormone Profile

INDIVIDUAL LIS TEST/PANEL CODES INCLUDED WITHIN PROFILE: FSH, LH, ESTRA, PROG, PROL, FTESTO, TESTO, SHBG, DHEAS, CORT

CPT CODE: 83001 (FSH) + 83002 (LH) + 82670 (ESTRA) + 84144 (PROG) + 84146 (PROL) + 84403 (TESTO) + 84270 (SHBG) + 82627 (DHEAS) + 82533 (CORT)

NOTE: Calculated Free Testosterone is a calculated result and is not separately billable. This is an MID-defined profile, not an AMA-recognized panel; components are billed individually and each must be supported by documented medical necessity for the individual patient.

ALIASES: Women's Hormone Panel, Female Endocrine Profile, Reproductive Hormone Panel, PCOS and Menstrual Irregularity Workup

METHODOLOGIES: Chemiluminescent Microparticle Immunoassay (CMIA)

PATIENT PREPARATION: Collection must occur in the morning, ideally between 7:00 and 10:00 AM. Cortisol, testosterone, and DHEA-S all demonstrate marked diurnal variation and are not interpretable from an afternoon draw. Fasting is not required. Prolactin should be collected 3 to 4 hours after waking with the patient at rest for 30 minutes prior to venipuncture. Avoid nipple stimulation, breast examination, and vigorous exercise before collection, as each transiently elevates prolactin.

Biotin must be withheld. Patients taking high-dose biotin (>5 mg per day, including hair, skin, and nail supplements) must discontinue for a minimum of 8 to 12 hours prior to collection, and 72 hours is preferred. Biotin interference on immunoassay platforms affects every component of this profile.

SPECIMEN:

- Type: Serum

- Container: 2 Gold Top (SST) Vacutainers

- Minimum Volume Required: 2 mL in each container.

- Storage/Handling: Allow 30 minutes for blood to clot, then centrifuge specimen at 3500 RPM for 10 minutes. Maintain specimen in the refrigerator until testing can be performed.

- Stability:

Room Temperature (20-25 °C): Not Accepted

Refrigerated (2-8 °C): 7 days

Frozen (-20 °C or colder): Not Accepted

- Turnaround Time: 24 - 48 hours from receipt.

Special Instructions: If testing will be delayed for more than 24 hours, remove serum from the separator gel and transfer into a separate plastic screw-cap transport container.

Total testosterone is measured by immunoassay, which has limited accuracy at the low concentrations typical of adult females. Where a precise value is clinically required, including the evaluation of hirsutism, suspected polycystic ovary syndrome, virilization, or suspected androgen-secreting tumor, order testosterone by LC-MS/MS as a separate referral test. A markedly elevated total testosterone or DHEA-S should prompt imaging for an ovarian or adrenal source rather than repeat serologic testing.

Free testosterone is calculated from total testosterone, SHBG, and albumin. Direct analog immunoassay free testosterone is not used in this profile, as the method correlates poorly with equilibrium dialysis across the clinically relevant range.

17-hydroxyprogesterone is not included in this profile. Non-classic congenital adrenal hyperplasia shares its presentation with polycystic ovary syndrome and is not excluded by testosterone and DHEA-S alone. Where androgen excess is the clinical question, order 17-hydroxyprogesterone separately, collected in the early follicular phase in the morning.

A single morning cortisol neither diagnoses nor excludes adrenal disease. It does not screen for Cushing syndrome, which requires late-night salivary cortisol, 24-hour urinary free cortisol, or dexamethasone suppression testing. A markedly low morning value raises concern for adrenal insufficiency and warrants ACTH stimulation testing; an intermediate value excludes neither condition.

An isolated elevated prolactin should be repeated before further evaluation. Venipuncture stress alone produces modest elevation. Persistent elevation without corresponding symptoms may reflect macroprolactin,

Interpret FSH and LH together with estradiol. Elevated FSH with low estradiol indicates ovarian insufficiency. Low or inappropriately normal gonadotropins with low estradiol indicate a hypothalamic or pituitary cause and warrant evaluation for hyperprolactinemia, thyroid disease, energy deficiency, and pituitary disease. An elevated LH to FSH ratio is supportive of but not diagnostic for polycystic ovary syndrome, and a normal ratio does not exclude it. Pregnancy must be excluded before interpreting this profile in a patient with amenorrhea.

Thyroid function testing is not included in this profile. TSH should be ordered concurrently in the evaluation of menstrual irregularity, amenorrhea, infertility, and galactorrhea, as thyroid dysfunction is a recognized cause of each.

REJECTION REASONS: QNS, Gross Hemolysis, Gross Lipemia, Contamination, Stability Violation, Expired Container, Incorrect Container

REFERENCE RANGES:

Please refer to individual test/panel directory pages for reference ranges for each test/panel included.