TEST DIRECTORY... | MIDx Labs

- PROFILE - ADULT WEIGHT LOSS MEDICATION MANAGEMENT

The Adult Weight Loss Medication Monitoring Profile establishes baseline status and tracks the metabolic, nutritional, hepatic, and endocrine parameters most affected by pharmacologic weight management, including GLP-1 and dual GIP/GLP-1 receptor agonist therapy. Comprehensive metabolic panel and CBC with automated differential monitor renal and hepatic function, electrolyte status, and hematologic parameters during sustained caloric restriction, with GGT providing additional hepatic sensitivity in patients with metabolic dysfunction-associated steatotic liver disease.

Glycemic and cardiometabolic response is followed through hemoglobin A1c, fasting insulin, the lipid panel, and Apolipoprotein B / Apolipoprotein A1 Ratio. Nutritional adequacy is assessed through iron studies with ferritin, Vitamin B12, Folate, and Vitamin D. These vitamins were chosen as deficiencies commonly develop when intake falls substantially, and this is compounded in patients concurrently receiving metformin. Thyroid function is evaluated as a contributor to weight regulation, and the gonadal axis is assessed through total testosterone, SHBG, calculated free testosterone, and estradiol, since obesity-associated functional hypogonadism in men frequently resolves with weight reduction and requires reassessment.

Intended for adults initiating or maintained on anti-obesity pharmacotherapy. Results characterize therapeutic response and nutritional adequacy; they do not assess drug-specific adverse events that present clinically rather than biochemically. Interpretation requires knowledge of the specific agent, dose, therapy duration, and concurrent medications, which should be recorded on the requisition.

LIS PROFILE CODE: (MID) Adult Weight Loss Medication Monitoring Profile

INDIVIDUAL LIS TEST/PANEL CODES INCLUDED WITHIN PROFILE: (MID) Comprehensive Metabolic Panel (CMP), (MID) Complete Blood Count with Automated Differential (CBCWD), HGBA1C, INSULIN, (MID) Lipid Panel (LP), (MID) Iron Panel (IP), FERR, (MID) Apolipoprotein B / Apolipoprotein A1 Ratio, TSH, FT4, GGT, FOLATE, B12, VITD, FTESTO, TESTO, SHBG, E2

CPT CODE: 80053 (CMP) + 85025 (CBCWD) + 83036 (HGBA1C) + 83525 (INS) + 80061 (LP) + 83540 (IRON) + 83550 (TIBC) + 82728 (FERR) + 82172 x 2 (APO B / APO A1 Ratio) + 84443 (TSH) + 84439 (FT4) + 82977 (GGT) + 82746 (FOLATE) + 82607 (B12) + 82306 (VITD) + 84403 (TESTO) + 84270 (SHBG) + 82670 (E2)

NOTE: Calculated Free Testosterone, Apo B / Apo A1 Ratio, 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: GLP-1 Monitoring Panel, Weight Management Monitoring Profile, Anti-Obesity Medication Monitoring, Metabolic Weight Loss Panel

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

RECOMMENDED SCHEDULE: Baseline prior to initiation, at 3 months, and every 6 - 12 months thereafter or as clinically indicated.

PATIENT PREPARATION: 9 - 12 hour fast (water permitted) required for the lipid panel, CMP glucose, insulin, and iron studies. Collection must occur in the morning, ideally between 7:00 and 10:00 AM as testosterone demonstrates marked diurnal variation and is 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, insulin, testosterone, estradiol, SHBG, ferritin, B12, folate, and vitamin D.

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): 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: 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.

Hemoglobin A1c is unreliable in the presence of anemia, hemoglobinopathy, recent transfusion, or any condition altering red cell survival. Iron deficiency falsely elevates A1c, and correction of iron deficiency lowers it independently of any change in glycemia. Review the A1c against the CBC and iron studies within this profile before attributing a change to therapeutic response.

Fasting insulin is measured by immunoassay and is not valid in patients receiving exogenous insulin; C-peptide should be ordered in that setting. Insulin values obtained during active GLP-1 or dual GIP/GLP-1 receptor agonist therapy reflect the insulinotropic effect of the agent and are not comparable to pre-treatment baseline values.

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.

For patients of childbearing potential, pregnancy status should be confirmed prior to initiation and during therapy; incretin-based and other anti-obesity agents are contraindicated in pregnancy. hCG is not included in this profile and must be ordered separately.

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.