TEST DIRECTORY... | MIDx Labs

- PROFILE - ESSENTIAL WELLNESS AND THYROID STATUS

The Essential Wellness and Thyroid Status Profile combines a baseline systemic health assessment with a focused evaluation of thyroid function. Comprehensive metabolic panel, CBC with automated differential, magnesium, and phosphorus establish renal, hepatic, electrolyte, and hematologic status, while GGT adds hepatic sensitivity and CRP provides a general marker of systemic inflammation. Hemoglobin A1c and the lipid panel characterize glycemic control and cardiovascular risk, and iron studies with ferritin evaluate iron availability and storage.

Thyroid assessment is anchored on TSH with Free T4, the combination that defines thyroid status in nearly all clinical settings, with Free T3 included for the evaluation of suspected thyrotoxicosis and thyroid peroxidase antibody to identify autoimmune thyroid disease. CK and LDH are included in recognition of the myopathy that accompanies untreated hypothyroidism and may be the presenting biochemical abnormality. Vitamin D and Vitamin B12 assess nutritional adequacy, and total testosterone, SHBG, calculated free testosterone, and estradiol evaluate the gonadal axis, which is frequently disturbed in both hypo- and hyperthyroid states.

Intended for adults seeking a periodic health evaluation with particular attention to thyroid function, and for the initial workup of presentations such as fatigue, weight change, cold or heat intolerance, hair or skin change, menstrual irregularity, or unexplained myalgia. Results are screening-level. Thyroid function testing should not be performed during acute non-thyroidal illness, where transient abnormalities are common and do not reflect underlying thyroid status.

LIS PROFILE CODE: (MID) Essential Wellness and Thyroid Status Profile

INDIVIDUAL LIS TEST/PANEL CODES INCLUDED WITHIN PROFILE: (MID) Comprehensive Metabolic Panel (CMP), (MID) Complete Blood Count with Automated Differential (CBCWD), (MID) Lipid Panel (LP), (MID) Iron Panel (IP), FERR, HGBA1C, MG, PHOS, CK, LDH, GGT, TSH, FT3, FT4, ATPO, CRPWR, VITD, B12, FTESTO, TESTO, SHBG, E2

CPT CODE: 80053 (CMP) + 85025 (CBCWD) + 80061 (LP) + 83540 (IRON) + 83550 (TIBC) + 82728 (FERR) + 83036 (HGBA1C) + 83735 (MG) + 84100 (PHOS) + 82550 (CK) + 83615 (LDH) + 82977 (GGT) + 84443 (TSH) + 84481 (FT3) + 84439 (FT4) + 86376 (ATPO) + 86140 (CRP) + 82306 (VITD) + 82607 (B12) + 84403 (TESTO) + 84270 (SHBG) + 82670 (E2)

NOTE: Calculated Free Testosterone and % Transferrin Saturation are calculated results and are not separately billable. 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.

ALIASES: Wellness and Thyroid Panel, Thyroid Status Profile, Comprehensive Wellness with Thyroid, Essential Wellness Screen

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

PATIENT PREPARATION: 9 - 12 hour fast (water permitted) required for the lipid panel, CMP glucose and iron studies. Collection should occur in the morning, ideally between 7:00 and 10:00 AM, as testosterone demonstrates marked diurnal variation, and TSH follows a diurnal rhythm that is highest overnight and in the early morning, so serial monitoring should use a consistent collection time. Oral iron and B12 supplements should be withheld for 24 hours prior. Avoid collection within 6 weeks of iodinated contrast administration where thyroid status is the primary question. Avoid strenuous physical activity for 24 - 48 hours prior; exertion, intramuscular injections, and recent trauma elevate CK.

Biotin must be withheld. Patients taking high-dose biotin (>5 mg/day, including hair, skin, and nail supplements) must discontinue for a minimum of 8 - 12 hours prior to collection, and 72 hours is preferred where thyroid status is the primary question. Biotin interference on immunoassay platforms produces falsely low TSH with falsely elevated Free T4 and Free T3, a pattern indistinguishable from thyrotoxicosis that has resulted in misdiagnosis and inappropriate treatment. Biotin additionally affects testosterone, estradiol, SHBG, ferritin, B12, vitamin D, and thyroid antibody results in this profile.

SPECIMEN:

- Type: Serum & Whole Blood

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

- Minimum Volume Required: 2 mL for each container.

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

- 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.

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.

- 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

- Turnaround Time: 24 - 48 hours from receipt.

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.

This profile reports free thyroid hormone fractions. Total T4 and Total T3 are not included, as both are confounded by thyroxine-binding globulin concentration and are altered by pregnancy, estrogen and oral contraceptive use, nephrotic syndrome, and hepatic disease independently of thyroid status. Total T3 remains available as a separate order where a standardized total measurement is preferred in the assessment of thyrotoxicosis. Free T3 has no role in the evaluation of hypothyroidism or in the monitoring of levothyroxine therapy and is included here for the assessment of suspected thyrotoxicosis.

Following a change in thyroid hormone dose, TSH requires approximately 6 weeks to reach a new steady state; earlier collection will not reflect the adjusted dose. For patients on levothyroxine, note the time of the last dose. Free T4 peaks approximately 2 - 4 hours following ingestion. Thyroid function testing is not interpretable during acute non-thyroidal illness. Low T3, and in severe illness low T4 with a non-elevated TSH, are expected findings in this setting and do not indicate thyroid disease.

Elevated CK in the presence of an elevated TSH should raise consideration of hypothyroid myopathy before other causes are pursued. Interpret any elevation against recent exertion, intramuscular injection, trauma, and statin therapy

Total testosterone and estradiol are measured by immunoassay. Immunoassay estradiol has limited accuracy at the low concentrations typical of adult males, and immunoassay testosterone has limited accuracy at the low concentrations typical of adult females. Where a precise value is clinically required, order the corresponding analyte by LC-MS/MS as a separate referral test. Reference ranges are sex-specific and age-stratified.

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.

REJECTION REASONS: Clotted Specimen, 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.