TEST DIRECTORY... | MIDx Labs

- PROFILE - ADVANCED FUNCTIONAL HEALTH EVALUATION

The Advanced Functional Health Evaluation is the most comprehensive profile in the MIDx menu, extending the core wellness evaluation across renal, hepatic, hematologic, metabolic, endocrine, autoimmune, and coagulation domains in a single collection event. Core chemistry and hematology, such as the comprehensive metabolic panel, CBC with automated differential, magnesium, phosphorus, GGT, CK, and LDH, establish baseline organ function. Glycemic and cardiometabolic status is characterized through hemoglobin A1c, fasting insulin, the lipid panel, APO B/ APO A1 Ratio, and Lipoprotein (a).

Nutritional adequacy is assessed through iron studies with ferritin, Vitamin B12, Folate, and Vitamin D. Endocrine evaluation covers thyroid function with autoimmune status (TSH, Free T4, Free T3, thyroid peroxidase antibody), the reproductive axis (FSH, LH, prolactin, estradiol, total testosterone, SHBG, calculated free testosterone), and adrenal androgen output (DHEA-S). Renal assessment is extended beyond serum creatinine to the urinary albumin-to-creatinine ratio, which detects glomerular injury at a stage preceding any change in serum chemistry. Coagulation screening is provided by PT/INR and aPTT, and CRP serves as a general marker of systemic inflammation.

Intended for adults seeking an in-depth baseline evaluation, and for the workup of complex or multisystem presentations where the differential spans several organ systems. This profile requires four separate specimen types and carries collection timing constraints that cannot all be satisfied in every patient; please review the Patient Preparation section before scheduling. Results are screening-level across most domains and should be interpreted in the context of the patient's age, sex, cycle phase, pregnancy status, medications, and clinical presentation.

LIS PROFILE CODE: (MID) Advanced Functional Health Evaluation 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, INSULIN, MG, PHOS, CK, LDH, GGT, (MID) Apolipoprotein B / Apolipoprotein A1 Ratio, LIPOA, TSH, FT3, FT4, ATPO, CRPWR, VITD, B12, FOLATE, FSH, LH, PRL, DHEAS, FTESTO, TESTO, SHBG, E2, (MID) MCR, (MID) PTINR, aPTT

CPT CODE: 80053 (CMP) + 85025 (CBCWD) + 80061 (LP) + 83540 (IRON) + 83550 (TIBC) + 82728 (FERR) + 83036 (HGBA1C) + 83525 (INS) + 83735 (MG) + 84100 (PHOS) + 82550 (CK) + 83615 (LDH) + 82977 (GGT) + 82172 x 2 (APO B / APO A1 Ratio) + 83695 (LIPOA) + 84443 (TSH) + 84481 (FT3) + 84439 (FT4) + 86376 (ATPO) + 86140 (CRP) + 82306 (VITD) + 82607 (B12) + 82746 (FOLATE) + 83001 (FSH) + 83002 (LH) + 84146 (PRL) + 82627 (DHEAS) + 84403 (TESTO) + 84270 (SHBG) + 82670 (E2) + 82043 (MALB) + 82570 (CREAU) + 85610 (PT/INR) + 85730 (APTT)

NOTE: Calculated Free Testosterone, the ApoB/ApoA1 ratiO, the MALB / CREA 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.

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. A profile of this size ordered against a single nonspecific diagnosis code represents a high-utilization pattern subject to payer review. The ordering provider should document the clinical rationale supporting each domain.

ALIASES: Advanced Wellness Profile, Comprehensive Functional Panel, Full Functional Health Assessment, Executive Health Profile

METHODOLOGIES: Spectrophotometry, Ion-Selective Electrode (ISE), Immunoturbidimetry, Chemiluminescent Microparticle Immunoassay (CMIA), Hydrodynamic Impedance, Laser-Based Flow Cytometry, Sodium Lauryl Sulfate (SLS) Hemoglobin, Mechanical Clot Detection, Reflectance Photometry (Colorimetry), Manual Microscopy (if Indicated)

PATIENT PREPARATION: 9 - 12 hour fast (water permitted) required for the lipid panel, CMP glucose, insulin, and iron studies. Collection should occur in the morning, ideally between 7:00 and 10:00 AM, as testosterone, DHEA-S, and cortisol-dependent parameters demonstrate marked diurnal variation, TSH follows a diurnal rhythm, and prolactin should be collected 3 - 4 hours after waking with the patient at rest for 30 minutes prior. Avoid nipple stimulation, breast examination, and vigorous exercise before collection. Oral iron, B12, and folate supplements should be withheld for 24 hours prior. Avoid strenuous physical activity for 24 - 48 hours prior; exertion, intramuscular injection, and recent trauma elevate CK and invalidate the urine albumin-to-creatinine ratio. Combined hormonal contraception suppresses FSH, LH, and estradiol and raises SHBG; the gonadal axis is not assessable in a patient on hormonal contraception.

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. Biotin interference on immunoassay platforms produces falsely low TSH with falsely elevated Free T4 and Free T3, a pattern indistinguishable from thyrotoxicosis, and additionally affects insulin, FSH, LH, prolactin, DHEA-S, testosterone, estradiol, SHBG, ferritin, B12, folate, vitamin D, and thyroid antibody results.

Urine collection: first-morning void preferred. Defer collection during menstruation, active urinary tract infection, or febrile illness, and for 24 hours following strenuous exercise; each produces false elevation of the albumin-to-creatinine ratio.

SPECIMEN:

- Type: Serum, Whole Blood, Citrated Plasma, and Random Urine

- Container: 1 Light-Blue Top (3.2% Sodium Citrate) Vacutainer, 3 Gold Top (SST) Vacutainers, 1 Lavender Top (K2/K3 EDTA) Vacutainer, and 1 Urine Container (Plain Yellow/Speckled Top)

- Minimum Volume Required: 2 mL for each container (except Light-Blue Top; tube must be filled to the stated fill volume; no partial fills accepted)

- Order of Draw: Light Blue Top (3.2% Sodium Citrate) first, followed by Gold Top (SST), then Lavender Top (K2/K3 EDTA), per CLSI GP41. If a winged collection set is used, draw a discard tube before the Light Blue Top to clear the tubing dead space.

- 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.

Light Blue Top (3.2% Sodium Citrate) Vacutainer - Gently invert specimen 8 - 10 times immediately following blood collection to prevent clotting. Do NOT refrigerate. Cold exposure activates Factor VII and causes cold-induced platelet activation. Maintain at room temperature and transport upright.

Urine Container (Plain Yellow/Speckled Top) - Maintain specimen in the refrigerator until testing can be performed.

Insulin requires prompt separation. Centrifuge and separate serum within 60 minutes of collection; insulin is degraded by red cell insulin-degrading enzyme in contact with cells.

Vitamin B12 and Folate are light-sensitive. Protect the aliquot from light from the point of separation through testing using an amber tube or foil wrap.

- 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, PT/INR, and aPTT)

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.

Coagulation screening. PT/INR and aPTT are poor predictors of bleeding risk in unselected individuals with no personal or family bleeding history, and isolated abnormalities, most commonly lupus anticoagulant or factor XII deficiency, neither of which causes bleeding, frequently prompt workups of no clinical benefit. A structured bleeding history is more informative than either assay in this setting.

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. Free T3 has no role in the evaluation of hypothyroidism or in the monitoring of levothyroxine therapy and is included for the assessment of suspected thyrotoxicosis.

Elevated CK in the presence of an elevated TSH should raise consideration of hypothyroid myopathy before other causes are pursued.

The albumin-to-creatinine ratio is the preferred measure for detection and staging of chronic kidney disease. A urine protein-to-creatinine ratio is not included and should be ordered separately where non-albumin proteinuria is suspected, including suspected monoclonal light chain disease or tubular proteinuria. A single abnormal albumin-to-creatinine ratio does not establish persistent albuminuria. Confirmation requires two of three abnormal specimens collected over a 3 - 6 month period.

Lipoprotein (a) is largely genetically determined and is generally measured once in a lifetime unless a therapy specifically targeting Lp(a) is initiated. Omit from repeat orders of this profile.

Hemoglobin A1c is unreliable in the presence of anemia, hemoglobinopathy, recent transfusion, or any condition altering red cell survival. Iron deficiency falsely elevates A1c. Review the A1c against the CBC and iron studies within this profile before interpreting it.

Fasting insulin is measured by immunoassay and is not valid in patients receiving exogenous insulin; C-peptide should be ordered in that setting.

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, including evaluation of hirsutism, PCOS, or suspected androgen-secreting tumor, 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 (Underfilled Light Blue Tops WILL be rejected), Refrigerated Coagulation Specimen, Moderate/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.