TEST DIRECTORY... | MIDx Labs

- PROFILE - MALE HORMONE

The Male Hormone Profile provides an assessment of the hypothalamic-pituitary-gonadal axis in adult men, together with the adrenal, pituitary, and metabolic parameters that most often accompany an abnormal result. Total testosterone establishes androgen status, and SHBG permits calculation of free testosterone, which is the more informative measure in men whose binding protein concentration is altered by age, obesity, diabetes, hepatic disease, or thyroid dysfunction.

FSH assesses pituitary drive and spermatogenic function. Prolactin is included because hyperprolactinemia is a common and treatable cause of secondary hypogonadism. DHEA-S assesses adrenal androgen output, and estradiol is measured in the evaluation of gynecomastia and in the monitoring of testosterone therapy, where excess aromatization is the usual mechanism. Fasting insulin is included in recognition of the strong association between insulin resistance and reduced testosterone. Total PSA establishes the baseline required before initiation of testosterone therapy and supports monitoring during treatment.

Intended for the evaluation of suspected hypogonadism, reduced libido, erectile dysfunction, infertility, gynecomastia, loss of muscle mass, or unexplained fatigue, and for baseline assessment prior to androgen therapy. Collection timing materially affects most components of this profile. Review the Patient Preparation section before scheduling.

LIS PROFILE CODE: (MID) Male Hormone Profile

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

CPT CODE: 84403 (TESTO) + 84270 (SHBG) + 83001 (FSH) + 84146 (PROL) + 82627 (DHEAS) + 82670 (ESTRA) + 84144 (PROG) + 84153 (PSA) + 83525 (INSULIN)

NOTE: Calculated Free Testosterone is a calculated result and is not separately billable. For Medicare beneficiaries, screening PSA is reported under HCPCS G0103 rather than 84153. 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: Men's Hormone Panel, Male Endocrine Profile, Hypogonadism Workup, Androgen Assessment Panel

METHODOLOGIES: Chemiluminescent Microparticle Immunoassay (CMIA)

PATIENT PREPARATION: 9 to 12 hour fast (water permitted) required for the insulin component. Collection must occur in the morning, ideally between 7:00 and 10:00 AM. Testosterone and DHEA-S both demonstrate marked diurnal variation and are not interpretable from an afternoon draw. Prolactin should be collected 3 to 4 hours after waking with the patient at rest for 30 minutes prior to venipuncture.

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.

For PSA, the patient should abstain from ejaculation for 48 hours and avoid cycling or vigorous exercise for 48 hours prior. Collection must precede digital rectal examination, prostate massage, catheterization, or cystoscopy.

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 or in the freezer until testing can be performed.

- Stability:

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

Refrigerated (2-8 °C): 7 days

Frozen (-20 °C or colder): 7 days; avoid multiple freeze/thaw cycles (only applicable to Insulin)

NOTE: Promptly transfer serum from one SST container into a separate plastic screw-cap transport container following centrifugation, and place in freezer to ensure accurate insulin testing.

- 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.

A single low testosterone result does not establish hypogonadism. Confirmation requires a second morning fasting measurement on a separate day, per Endocrine Society guidance. Testosterone falls transiently with acute illness, sleep deprivation, and caloric restriction, and a result obtained in any of those settings should be repeated after recovery.

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. Estradiol is measured by immunoassay. Immunoassay estradiol has limited accuracy at the low concentrations typical of adult males. Where a precise male estradiol value is clinically required, including the evaluation of gynecomastia or suspected aromatase excess, order estradiol by LC-MS/MS as a separate referral test.

Progesterone has a limited role in adult male endocrine assessment, and male concentrations approach the lower limit of the assay range. Where congenital adrenal hyperplasia is the clinical question, 17-hydroxyprogesterone is the appropriate test and should be ordered separately.

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

Hematocrit is not assessed by this profile. Erythrocytosis is the most common adverse effect of testosterone therapy. Where this profile is used to monitor androgen therapy, order a CBC concurrently and follow hematocrit at baseline, at 3 to 6 months, and annually thereafter. Reference ranges for testosterone, SHBG, DHEA-S, and estradiol are age-stratified.

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.