Summary & Overview
CPT 0408U: Omnia SARSCoV-2 Antigen Test, Automated BAW Immunoassay
CPT code 0408U designates a Proprietary Laboratory Analyses (PLA) test specific to the Omnia™ SARSCoV–2 Antigen Test from Qorvo Biotechnologies. It captures a laboratory-based automated immunoassay that uses a bulk acoustic wave (BAW) biosensor on nasal swab specimens to detect SARS–CoV–2 antigens. This PLA code matters nationally because it identifies a manufacturer-specific diagnostic method tied to a single proprietary test, aiding payers and providers in claims processing, inventory tracking, and epidemiologic surveillance of COVID–19 testing technologies.
Key payers discussed include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise description of the test and its clinical context, an explanation of typical sites of service and service type, and a summary of payer coverage focus. The publication outlines benchmarking and payment considerations tied to PLA coding, highlights policy updates that affect laboratory proprietary codes, and provides clinical context for antigen testing methods using automated immunoassay and BAW biosensor technologies. Data not available in the input are explicitly noted where applicable.
Billing Code Overview
CPT code 0408U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the Omnia™ SARSCoV–2 Antigen Test from Qorvo Biotechnologies. The test evaluates a nasal swab specimen using an automated instrument that performs an immunoassay procedure combined with a bulk acoustic wave (BAW) biosensor to detect antigens from severe acute respiratory syndrome coronavirus 2 (SARS–CoV–2), the virus that causes COVID–19.
Service type: Laboratory diagnostic test using an automated immunoassay with a BAW biosensor.
Typical site of service: Clinical laboratory or other facility-based laboratory setting where automated immunoassay instruments are used.
Clinical & Coding Specifications
Clinical Context
A symptomatic adult presents to an outpatient clinic or urgent care reporting 48 hours of nasal congestion, sore throat, fever, and new cough during a local COVID-19 surge. A clinician performs a brief history and focused respiratory exam, documents symptom onset and exposure risk, and collects a nasal swab specimen using the Omnia™ nasal swab collection kit. The specimen is processed on-site or in a nearby certified laboratory using the Omnia™ SARSCoV–2 Antigen Test implemented on an automated immunoassay instrument with a bulk acoustic wave (BAW) biosensor. Results are available within the laboratory instrument runtime and are documented in the electronic health record; a positive result prompts isolation counseling and reporting per public health rules, while a negative result in a high-pretest-probability patient may trigger reflex PCR testing. Typical workflow locations include outpatient clinics, urgent care centers, hospital laboratories, and CLIA-certified reference or local laboratories performing the proprietary assay.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
00 | Unclassified | Rarely used; reserve for payer-specific reporting when no other modifier applies |
26 | Professional component |