MICHIGAN INNOVATIVE DIAGNOSTICS

The Men's Wellness Check is a broad baseline assessment of the organ systems and hormonal axes most commonly implicated in adult male health complaints. Core chemistry and hematology, such as the comprehensive metabolic panel, CBC with automated differential, magnesium, phosphorus, uric acid, and GGT, establish renal, hepatic, electrolyte, and hematologic status. Hemoglobin A1c and the lipid panel characterize glycemic control and cardiovascular risk. Iron studies with ferritin evaluate iron availability and storage, and CRP provides a general marker of systemic inflammation.

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The endocrine component assesses thyroid function (TSH with Free T4), adrenal output (morning cortisol), vitamin D status, and the gonadal axis through total testosterone, SHBG, calculated free testosterone, and estradiol collectively are required to interpret androgen status accurately, since total testosterone alone is confounded by binding protein concentration. Prostate-specific antigen is included for prostate assessment in men for whom PSA testing is appropriate.

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Intended for adult men seeking a periodic health evaluation, and for the initial workup of nonspecific presentations such as fatigue, low libido, weight change, or reduced exercise tolerance. Results are screening-level and should be interpreted in the context of the patient's age, symptoms, medications, and family history. Abnormal results generally require confirmatory or directed follow-up testing rather than treatment on a single value.

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LIS PROFILE CODE: (MID) Men's Wellness Check

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INDIVIDUAL LIS TEST/PANEL CODES INCLUDED WITHIN PROFILE: (MID) Comprehensive Metabolic Panel (CMP), (MID) Complete Blood Count with Automated Differential (CBCWD), HGBA1C, (MID) Lipid Panel (LP), (MID) Iron Panel (IP), FERR, CRPWR, MG, GGT, PHOS, URIC, TSH, FT4, PSA, CORT, FTESTO, TESTO, SHBG, E2, VITD

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CPT CODE: 80053 (CMP) + 85025 (CBCWD) + 83036 (HGBA1C) + 80061 (LP) + 83540 (IRON) + 83550 (TIBC) + 82728 (FERR) + 86140 (CRP) + 83735 (MG) + 82977 (GGT) + 84100 (PHOS) + 84550 (URIC) + 84443 (TSH) + 84439 (FT4) + 84153 (PSA) + 82533 (CORT) + 84403 (TESTO) + 84270 (SHBG) + 82670 (E2) + 82306 (VITD)

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NOTE: Calculated Free Testosterone and % Transferrin Saturation are calculated results and are not separately billable. For Medicare beneficiaries, screening PSA is reported under HCPCS G0103 rather than 84153. This is a 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. 

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ALIASES: Men's Health Panel, Male Wellness Profile, Comprehensive Men's Screening, Men's Annual Panel

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METHODOLOGIES: Spectrophotometry, Ion-Selective Electrode (ISE), Immunoturbidimetry, Chemiluminescent Microparticle Immunoassay (CMIA), Hydrodynamic Impedance, Laser-Based Flow Cytometry, Sodium Lauryl Sulfate (SLS) Hemoglobin

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PATIENT PREPARATION: 9 - 12 hour fast (water permitted) required for the lipid panel, CMP glucose, and iron studies. Collection must occur in the morning, ideally between 7:00 and 10:00 AM as testosterone and cortisol both demonstrate marked diurnal variation and are not interpretable from an afternoon draw. Oral iron supplements should be withheld for 24 hours prior. Patients taking high-dose biotin (>5 mg/day) should withhold supplementation for a minimum of 8 - 12 hours prior to collection; biotin interferes with the immunoassay components of this profile, including TSH, Free T4, testosterone, estradiol, cortisol, SHBG, ferritin, vitamin D, and PSA.

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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. Note any 5-alpha reductase inhibitor therapy (finasteride, dutasteride) on the requisition, as these agents reduce PSA by approximately half. Defer PSA collection for 6 weeks following prostate biopsy or acute prostatitis.

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SPECIMEN:

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- Type: Serum & Whole Blood

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- Container: 2 Gold Top (SST) Vacutainers & 1 Lavender Top (K2/K3 EDTA) Vacutainer

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- Minimum Volume Required: 2 mL for each container.

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- Order of Draw: Gold Top (SST) before Lavender Top (K2/K3 EDTA) per CLSI GP41.

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- Storage/Handling:

 

Gold Top (SST) Vacutainer - Allow 30 minutes for blood to clot, then centrifuge specimen at 3500 RPM for 10 minutes. Maintain specimen at room temperature or in the refrigerator until testing can be performed.

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Lavender Top (K2/K3 EDTA) Vacutainer - Gently invert specimen 8 - 10 times immediately following blood collection to prevent clotting. Maintain specimen at room temperature or in the refrigerator until testing can be performed.

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- Stability:   

 

Room Temperature (20-25 °C): 2 hours

Refrigerated (2-8 °C): 2 days (please note however that cellular degeneration can occur as soon as 24 hours post-collection)

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

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- Turnaround Time: 24 - 48 hours from receipt.

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Special Instructions: Specimens meeting predefined criteria (e.g., flagged morphologic abnormalities, significant differential shifts, or critical count thresholds) will automatically reflex to a peripheral blood smear review by a medical laboratory scientist at no additional charge.

 

Depending on the findings identified on smear review, the specimen may be further escalated to pathologist for final interpretation, and any additional testing will be added to the original order.

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Free testosterone is calculated from total testosterone, SHBG, and albumin. Direct analog immunoassay free testosterone is not performed, as the method is unreliable 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, order estradiol by LC-MS/MS as a separate referral test. A single low testosterone result does not establish hypogonadism. Confirmation requires a second morning fasting measurement on a separate day, per Endocrine Society guidance.

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Ferritin is an acute-phase reactant. A normal or elevated ferritin does not exclude iron deficiency in the presence of infection, inflammation, malignancy, or chronic kidney disease. CRP in this profile is standard-sensitivity CRP (86140) and is intended as a general inflammatory marker. It is not interchangeable with high-sensitivity CRP (86141) for cardiovascular risk stratification. 

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

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REFERENCE RANGES:​

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

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