CPT 0527U: Abbott Alinity m HSV 1 & 2 and VZV Molecular Assay

CPT code 0527U identifies a proprietary molecular diagnostic assay—the Abbott Alinity™ m HSV 1 & 2 / VZV Assay—that detects HSV-1, HSV-2 and varicella zoster virus (VZV) in clinical specimens. As a PLA code, 0527U represents a single manufacturer's test and is used when reporting that specific assay. Nationally, proprietary molecular assays like this are important for rapid, pathogen-specific diagnosis that can guide infection control and antiviral management.

Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare and Medicare. The publication provides benchmarks and context for coverage and reimbursement for proprietary laboratory analyses, summarizes clinical indications and testing workflow, and highlights implications for laboratory service lines that perform high-complexity molecular testing. Readers will find a concise description of the test and service setting, comparison points for payer coverage considerations, and clinical context on when HSV and VZV molecular testing is used. Data not available in the input is identified where applicable.

Billing Code Overview

CPT code 0527U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the Abbott Alinity™ m HSV 1 & 2 / VZV Assay from Abbott Molecular Inc. The assay uses an amplified probe technique to detect herpes simplex virus type 1 (HSV-1), herpes simplex virus type 2 (HSV-2), and varicella zoster virus (VZV) in clinical specimens, with results reported for each pathogen as detected or not detected.

Service type: Molecular diagnostic infectious disease testing (proprietary laboratory assay)

Typical site of service: Clinical laboratory or hospital laboratory performing molecular diagnostics

Clinical Context

A 28-year-old immunocompetent adult presents to an urgent care clinic with a painful vesicular rash on the lip and oral mucosa and reports fever and prodromal tingling. The clinician obtains a swab of the lesion and orders the Abbott Alinity™ m HSV 1 & 2 / VZV Assay to identify herpes simplex virus type 1, herpes simplex virus type 2, or varicella zoster virus to guide infection control and antiviral selection. The specimen is transported to the laboratory where a molecular technologist performs the proprietary amplified probe assay. Results are reported as each pathogen “detected” or “not detected.” Typical sites of service include hospital outpatient laboratory, independent clinical laboratory, reference laboratory, and urgent care or ambulatory clinic collecting and sending specimens. The service type is a laboratory molecular diagnostic test (Proprietary Laboratory Analyses, PLA). Common clinical workflow steps: clinician evaluation and specimen collection; specimen accessioning and testing on the Abbott Alinity™ m platform; documentation of results in the laboratory information system; transmission of results to the ordering provider; and clinical interpretation and management by the ordering clinician.

Coding Specifications

Modifier	Description	When to Use
`00`	No modifier	Use when no special modifier applies and the full service is billed
`26`

Taxonomy Code	Specialty	Notes
261Q00000X	Pathology	Clinical laboratory directors and molecular pathologists overseeing testing
207RH0000X	Infectious Disease	Infectious disease physicians ordering and interpreting complex viral diagnostics
207L00000X	Family Medicine	Primary care clinicians and urgent care providers who collect specimens and manage patients
207P00000X	Emergency Medicine	Emergency physicians ordering rapid diagnostics for acute vesicular or neurologic presentations
3336C0002X	Clinical Laboratory	Clinical laboratory scientists/technologists performing the assay

Related CPT Codes

CPT Code	Description	Relationship to This Procedure
`87479`	Infectious agent detection by nucleic acid (DNA or RNA); amplified probe, multiple organisms (e.g., HSV 1/2, VZV)	Alternative molecular method codes sometimes used historically for multiplex viral detection; relates as similar nucleic acid detection approach
`87633`	Infectious agent detection by nucleic acid (DNA or RNA), herpes simplex virus types 1 and 2, amplified probe technique	Commonly performed for HSV testing; may be ordered when a non-proprietary HSV-specific assay is used
`87338`	Infectious agent antigen detection, screening, multiple types or subtypes (e.g., rapid immunoassay)	Antigen-based rapid testing that may be performed at point of care prior to sending PCR assay
`87420`	Infectious agent detection by nucleic acid (DNA or RNA); varicella zoster virus, amplified probe technique	VZV-specific molecular test that may be ordered when only VZV is suspected
`99000`	Handling and/or conveyance of specimen for transfer from physician office to laboratory	Administrative/transportation code sometimes used when specimen logistics are charged or reported

Related Diagnoses

ICD-10 Code	Description	Clinical Relevance
`B00.0`	Eczema herpeticum due to herpes simplex	HSV testing to confirm active HSV infection in disseminated skin disease
`B00.1`	Herpesviral vesicular dermatitis	Lesion testing to identify HSV as cause of vesicular dermatitis
`B00.2`	Herpesviral gingivostomatitis and pharyngotonsillitis	Oral lesion swab testing for HSV-1 or HSV-2
`B02.9`	Varicella zoster without complication	VZV testing to distinguish primary varicella or localized zoster from HSV
`B02.0`	Zoster with meningitis	CSF or lesion testing for VZV in suspected neurologic involvement

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Summary & Overview