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    v1.0.28
    OpenPayerBilling CodesProprietary Laboratory AnalysesCPT cpt-0581u-non-hla-autoantibody-panel-mayo-clinic
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    CPT 0581U: Autoantibody to Non–HLA (Mayo Clinic)

    CPT code 0581U is a Proprietary Laboratory Analyses (PLA) test for Autoantibody to Non–Human Leukocyte Antigen (non–HLA) developed and reported by Mayo Clinic Jacksonville; it analyzes a patient’s blood using flow cytometry and single–antigen bead technology to detect and report antibodies against 39 distinct non–HLA targets that may affect transplant outcomes, and the service is a specialized laboratory immunology test typically performed in a clinical laboratory or reference lab setting.

    For related coverage guidance, see recent payer policy updates: RTM Testing of Homocysteine Metabolism-Related Conditions, Multimarker Serum Testing Related to Ovarian Cancer, B-Hemolytic Streptococcus Testing.

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    Clinical & Coding Specifications

    Clinical Context

    A 52-year-old patient undergoing evaluation for kidney transplantation at a tertiary transplant center has a pre-transplant immunology workup. The transplant team orders the Mayo Clinic Jacksonville proprietary assay 0581U to detect autoantibodies directed against 39 non–HLA targets that can influence graft outcomes. A peripheral blood sample is collected in the outpatient phlebotomy lab and sent to the performing laboratory. The test uses flow cytometry and single–antigen bead technology; results are reviewed by the transplant immunology service and incorporated into donor selection, risk stratification, and post‑transplant monitoring plans. Typical workflow steps include: order entry by transplant physician, specimen collection and labeling, courier transport to Mayo Clinic Jacksonville or designated performing lab, laboratory processing and reporting of detected non‑HLA antibodies, and multidisciplinary review by transplant surgery, nephrology, and transplant immunology.

    Related CPT Codes

    CPT CodeDescriptionRelationship to This Procedure
    80053Comprehensive metabolic panelBaseline metabolic assessment commonly performed in pre-transplant evaluation
    83520Immunoassay for analyte other than infectious agent antibody(ies)General immunoassay code sometimes used for other antibody testing in the transplant workup
    86361Antibody; qualitative or semiquantitative, single step methodRelated immunology lab methodologies performed in parallel or for corroboration
    88360Immunohistochemistry or immunocytochemistry, per specimen; initial single antibody stainPerformed when tissue-based antibody testing or biopsy adjuncts are indicated in transplant assessment
    86999Unlisted immunology procedureUsed when reporting nonstandard laboratory procedures not described by other CPT codes

    Related Modifiers

    5 rows

    ModifierDescriptionWhen to Use
    22Modifier –22 (Increased Procedural Services) is used when a reported procedure is substantially more extensive than normally required. The CPT Manual and CMS state it may be appended only when the…- When to use: Append modifier -22 to a procedural CPT code when the service performed is substantially more extensive than the usual service described by that code — i.e., the procedure required…
    52Modifier ‑52 (Reduced Services) indicates that a service or procedure was partially reduced or omitted at the provider’s discretion, allowing reporting of the basic procedure number with a qualifier…- Use modifier -52 when a physician or qualified health professional electively reduces or omits part of a procedure or service (for example, performing fewer required views or omitting a portion of…
    53Modifier 53 (Discontinued Procedure) signals that a surgical or diagnostic service was begun by the physician but terminated because of extenuating circumstances that threatened the patient’s…- Use modifier -53 when a physician/qualified healthcare professional has started a surgical or diagnostic procedure (e.g., anesthesia administered, incision or scope insertion) and then discontinues…
    2PModifier -2P is a Category II performance‑measure exclusion appended to a CPT Category II (quality) code when the provider did not perform the measured action because of patient‑related reasons (for…- Use modifier 2P only with CPT Category II (performance‑measure) codes when a patient‑specific reason prevented performance of the measured action (for example, patient refusal, economic or social…
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    Related Provider Taxonomies

    8 rows

    Taxonomy CodeSpecialtyNotes
    2080P0207XPediatric Hematology & Oncology PhysicianA pediatrician trained in the combination of pediatrics, hematology and oncology to recognize and manage pediatric blood disorders and cancerous disea…
    208000000XPediatrics PhysicianA pediatrician is concerned with the physical, emotional and social health of children from birth to young adulthood. Care encompasses a broad spectru…
    207L00000XAnesthesiology PhysicianAn anesthesiologist is trained to provide pain relief and maintenance, or restoration, of a stable condition during and immediately following an opera…
    207K00000XAllergy & Immunology PhysicianAn allergist-immunologist is trained in evaluation, physical and laboratory diagnosis, and management of disorders involving the immune system. Select…
    3418M1110XMilitary or U.S. Coast Guard Ground Transport AmbulanceVehicle and staff for patient emergency or non-emergency ground transport. Includes traditional ambulances as well as ambulance buses.
    207RH0003XHematology & Oncology PhysicianAn internist doctor of osteopathy that specializes in the treatment of the combination of hematology and oncology disorders. A doctor of osteopathy t…
    261QM2500XMedical Specialty Clinic/CenterAn entity, facility, or distinct part of a facility providing diagnostic, treatment, and prescriptive services related to a specific area of medical s…
    2278P3800XPalliative/Hospice Certified Respiratory TherapistA coordinated plan of care to help dying patients and their families handle the burden of terminal care. Effective secretion management and relief of…

    Related Payer Policy Updates

    Specialty: Genetic & Molecular Testing1 / 3

    2 rows

    PolicyPayerEffective Date
    RTM Testing of Homocysteine Metabolism-Related ConditionsOscar Health2026-10-01
    Multimarker Serum Testing Related to Ovarian CancerBlue Cross Blue Shield - Rhode Island2026-09-01

    Related Codes

    CPT-0001U-PRECISETYPE-HEA-MULTIPLEX-RBC-ANTIGEN-GENOTYPING

    CPT 0001U: PreciseType HEA Erythrocyte Antigen Genotyping

    CPT-0002U-POLYPDX-URINE-METABOLOMIC-ASSAY-ADENOMATOUS-POLYP-RISK

    CPT 0002U: PolypDX™ Urine Metabolomic Risk Assay

    CPT-0003U-OVAR-A-NEXT-GENERATION-OVARIAN-CANCER-RISK-ASSAY

    CPT 0003U: Overa (MIA2G) Ovarian Cancer Risk Assay

    CPT-0005U-PROSTATE-EXOSOMEDX-INTELLISCORE-GENE-EXPRESSION-URINE-TEST

    CPT 0005U: ExosomeDx Prostate (IntelliScore) urine gene expression test

    CPT-0007U-TOXPROTECT-URINE-DRUG-SCREEN-WITH-DNA-AUTHENTICATION

    CPT 0007U: ToxProtect Urine Drug Screen With DNA Authentication

    CPT-0008U-H-PYLORI-ANTIBIOTIC-RESISTANCE-SEQUENCING-PANEL

    CPT 0008U: H. pylori Antibiotic Resistance Gene Panel

    CPT-0009U-DEPARRAY-HER2-FISH-TUMOR-CELL-ISOLATION

    CPT 0009U: DEPArray HER2 Tumor‑Cell Isolation with FISH Analysis

    CPT-0010U-BACTERIAL-TYPING-WHOLE-GENOME-SEQUENCING-MAYO-CLINIC

    CPT 0010U: Bacterial Typing by Whole Genome Sequencing, Mayo Clinic

    CPT-0011U-CORDANT-CORE-ALGORITHMIC-ORAL-FLUID-DRUG-TEST

    CPT 0011U: Oral Fluid Drug Test with Algorithmic Steady‑State Comparison

    CPT-0016U-BCR-ABL1-MAJOR-MINOR-FUSION-TRANSCRIPT-TESTING

    CPT 0016U: BCR–ABL1 Major and Minor Breakpoint Fusion Transcripts

    Showing 1–10 of 536

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    Frequently Asked Questions

    References

    1. 1.CPT® Codes and Descriptions. AAPC. Retrieved Aug 11, 2026.Maintains the CPT code set's official descriptions and guidelines, licensed from the American Medical Association, used as the definitional source for CPT codes on this page.
    2. 2.HCPCS Quarterly Update. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's quarterly release of HCPCS Level II codes and short/long descriptors, the source for HCPCS code definitions and update history.
    3. 3.ICD-10-CM Full Code List. Centers for Medicare & Medicaid Services (CMS). Retrieved Aug 11, 2026.CMS's complete ICD-10-CM diagnosis code list, used to cross-reference diagnosis codes associated with this procedure or service.
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