Summary & Overview
CPT 0402U: Abbott Alinity m Multiplex STI Assay
CPT code 0402U denotes a Proprietary Laboratory Analyses (PLA) code for the Abbott Alinity™ m STI Assay, a multiplex molecular test that detects Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium from vaginal, endocervical, or male urine specimens. As a PLA code, 0402U is specific to a single manufacturer's test and is used to identify that proprietary assay in billing and claims data. Nationally, accurate coding of PLA tests matters for surveillance of STI testing utilization, clarity in lab billing, and tracking adoption of new multiplex diagnostics.
Key payers covered in this overview include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise explanation of the clinical purpose and service setting for the assay, plus context on what to expect in payer coverage discussions and claims workflows when PLA codes are used. The publication outlines benchmarking and policy-relevant topics such as coding specificity for proprietary assays, implications for laboratory billing, and clinical context for multiplex STI testing. Data not available in the input is noted where applicable.
Billing Code Overview
CPT code 0402U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the Abbott Alinity™ m STI Assay from Abbott Molecular Inc. The test evaluates a vaginal, endocervical, or male urine specimen using a multiplex amplified probe technique to detect four sexually transmitted infection organisms: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium.
Service type: Molecular multiplex infectious disease testing (proprietary laboratory assay)
Typical site of service: Clinical laboratory, hospital laboratory, or other certified diagnostic laboratory processing patient-collected vaginal, endocervical, or urine specimens
Clinical & Coding Specifications
Clinical Context
A 24-year-old sexually active woman presents to a primary care clinic with new-onset vaginal discharge and lower abdominal discomfort. The clinician collects a vaginal swab specimen and documents risk factors including multiple sexual partners and inconsistent condom use. The specimen is sent to the laboratory for the Abbott Alinity™ m STI Assay. The assay is performed in a certified clinical laboratory using a multiplex nucleic acid amplification test to detect Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. Results are returned to the ordering clinician within the lab’s validated turnaround time and used to guide targeted antimicrobial therapy and partner notification as appropriate.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | No modifier | Standard reporting when no modifier applies to the PLA test |
26 |