TEST DIRECTORY... | MIDx Labs

- PROFILE - WOMEN'S WELLNESS CHECK

The Women's Wellness Check is a broad baseline assessment of the organ systems and hormonal axes most commonly implicated in adult female health complaints. Core chemistry and hematology, such as the comprehensive metabolic panel, CBC with automated differential, magnesium, phosphorus, and uric acid, 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, a frequent finding in menstruating women, and CRP provides a general marker of systemic inflammation.

The endocrine component assesses thyroid function (TSH with Free T4), adrenal output (morning cortisol), vitamin D status, and the reproductive axis through FSH, LH, estradiol, progesterone, prolactin, total testosterone, SHBG, and calculated free testosterone. These reproductive markers are cycle-dependent and are interpretable only in reference to the patient's menstrual cycle day or menopausal status.

Intended for adult women seeking a periodic health evaluation, and for the initial workup of presentations such as fatigue, menstrual irregularity, subfertility, hirsutism, weight change, or suspected perimenopausal transition. Results are screening-level and should be interpreted in the context of the patient's age, cycle phase, pregnancy status, hormonal contraception, symptoms, and family history. Abnormal results generally require confirmatory or directed follow-up testing rather than treatment on a single value.

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

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, PHOS, URIC, TSH, FT4, CORT, E2, PROG, FSH, LH, PRL, FTESTO, TESTO, SHBG, VITD

CPT CODE: 80053 (CMP) + 85025 (CBCWD) + 83036 (HGBA1C) + 80061 (LP) + 83540 (IRON) + 83550 (TIBC) + 82728 (FERR) + 86140 (CRP) + 83735 (MG) + 84100 (PHOS) + 84550 (URIC) + 84443 (TSH) + 84439 (FT4) + 82533 (CORT) + 82670 (E2) + 84144 (PROG) + 83001 (FSH) + 83002 (LH) + 84146 (PRL) + 84403 (TESTO) + 84270 (SHBG) + 82306 (VITD)

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.

ALIASES: Women's Health Panel, Female Wellness Profile, Comprehensive Women's Screening, Women's Annual Panel

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 must occur in the morning, ideally between 7:00 and 10:00 AM as cortisol and testosterone 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, estradiol, progesterone, FSH, LH, prolactin, testosterone, cortisol, SHBG, ferritin, and vitamin D.

For assessment of ovarian reserve or menopausal transition, collect on cycle day 2 - 5. For confirmation of ovulation, progesterone must be collected mid-luteal, approximately 7 days before the expected onset of menses. These two windows cannot be satisfied by a single draw in a cycling patient.

For prolactin, the patient should be at rest for 30 minutes prior to venipuncture and collection should occur 3 - 4 hours after waking. Avoid nipple stimulation, breast examination, and vigorous exercise prior to collection; each transiently elevates prolactin.

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.

Combined hormonal contraception suppresses FSH, LH, estradiol, and progesterone and raises SHBG; the gonadal axis is not assessable in a patient on hormonal contraception. Total testosterone is measured by immunoassay. Immunoassay testosterone has limited accuracy at the low concentrations typical of adult females; where a precise female testosterone value is clinically required, including evaluation of hirsutism, PCOS, or suspected androgen-secreting tumor, order testosterone by LC-MS/MS as a separate referral test. 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.

An isolated elevated prolactin should be repeated before further evaluation. Persistent elevation without corresponding symptoms may reflect macroprolactin.

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.