Summary & Overview
CPT 0574U: NanoDetect–TB™ LC–MS Test for CFP–10 Tuberculosis Detection
CPT code 0574U designates the NanoDetect–TB™ proprietary laboratory assay from NanoPin Technologies Inc., a serum- or plasma-based liquid chromatography–mass spectrometry (LC–MS) test that detects the CFP–10 protein to aid identification of active Mycobacterium tuberculosis infection. As a PLA code, 0574U is single-source and specific to this manufacturer’s test, which has implications for billing, coding clarity, and payer policy development nationwide. Key national payers included in this analysis are 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 test, an overview of payer coverage considerations and common modifier use, and where available, benchmarking context for proprietary laboratory analyses. The publication also outlines clinical context for using an LC–MS CFP–10 assay compared with other tuberculosis diagnostics and highlights administrative factors tied to PLA codes, such as coding specificity and single-source reporting. Data not provided in the input are noted where applicable.
Billing Code Overview
CPT code 0574U is a Proprietary Laboratory Analyses (PLA) code that applies exclusively to the NanoDetect–TB™ assay from NanoPin Technologies Inc. The test detects the tuberculosis protein CFP–10 in serum or plasma using liquid chromatography mass spectrometry (LC–MS) and is intended to help identify active Mycobacterium tuberculosis infection.
Service type: Laboratory diagnostic test (proprietary PLA)
Typical site of service: Clinical laboratory or hospital laboratory, with specimens collected in outpatient clinics or hospital settings
Data not available in the input.
Clinical & Coding Specifications
Clinical Context
A typical patient is an adult or adolescent presenting with signs or symptoms suggestive of active tuberculosis (TB), such as persistent cough, weight loss, night sweats, hemoptysis, or fever, or a patient with radiographic findings (eg, cavitary lung lesion) suspicious for pulmonary TB. The clinician (infectious disease specialist, pulmonologist, or primary care physician) orders 0574U (NanoDetect–TB™) when rapid, specific detection of the Mycobacterium tuberculosis CFP‑10 protein in serum or plasma will aid in diagnosing active infection, particularly when sputum is unobtainable, smear‑negative, or when prior nucleic acid tests are inconclusive.
The clinical workflow: a phlebotomy draw of serum or plasma is collected and sent to the performing laboratory, which runs the proprietary liquid chromatography–mass spectrometry (LC–MS) assay for CFP‑10. Results are reported back to the ordering clinician and integrated with clinical findings, imaging, and microbiology (eg, sputum smear, culture, NAAT) to establish the diagnosis of active TB and guide isolation, treatment initiation, and public health reporting. Typical site of service is an outpatient clinic, hospital outpatient department, or clinical laboratory receiving specimens from inpatient wards or emergency departments.
Coding Specifications
| Modifier | Description | When to Use |
|---|---|---|
22 | Increased procedural services | Use when the laboratory documents increased complexity, time, or resources beyond typical for the test (rare for PLA codes but applicable if additional validated procedures are required). |
52 | Reduced services | Use if the test was only partially completed or a limited version of the assay was performed. |
53 | Discontinued procedure | Use when specimen processing or assay run was started but discontinued for clinical or technical reasons. |
59 | Distinct procedural service | Use when another unrelated test or procedure is reported on the same date and documentation supports separate services. |
26 | Professional component | Use when billing is separated into professional (interpretation) and technical components and the lab bills only the professional portion. |
TC | Technical component | Use when billing only the technical component (laboratory performance of the test) and not the professional interpretation. |
91 | Repeat clinical diagnostic laboratory test | Use when the identical test is repeated on a separate specimen to confirm results within a clinically appropriate interval. |
QW | CLIA-waived test | Not typically applicable to LC‑MS PLA; include only if a waived version exists and CLIA waiver applies. |
KX | Requirements specified in coverage policy met | Use when medical necessity or other payer policy prerequisites are documented and required for payment. |
XE | Separate encounter, a distinct service | Use when the same CPT/PLA code is reported for a separate encounter on the same date and documentation supports distinct encounters. |
| Taxonomy Code | Specialty | Notes |
|---|---|---|
| 207Q00000X | Infectious Disease | Specialists ordering advanced TB diagnostics and interpreting results in complex cases. |
| 207RP1001X | Pulmonary Disease | Pulmonologists evaluating suspected pulmonary TB and coordinating diagnostic testing. |
| 208000000X | Family Medicine | Primary care clinicians initiating TB workup in outpatient settings. |
| 261QM0800X | Public Health & General Preventive Medicine | Public health clinicians coordinating testing for TB exposure investigations. |
| 363LP0800X | Laboratory Director | Clinical laboratory medical directors overseeing PLA test validation, performance, and reporting. |
Related Diagnoses
| ICD-10 Code | Description | Clinical Relevance |
|---|---|---|
A15.0 | Tuberculosis of lung, confirmed by sputum microscopy with other and unspecified methods | Direct indication for testing to confirm active pulmonary TB when rapid, specific antigen detection is needed. |
A15.7 | Tuberculosis of other respiratory organs | Relevant when TB affects bronchial structures and serum/plasma CFP‑10 may support active disease diagnosis. |
A17.0 | Tuberculosis meningitis | Systemic TB involvement where blood‑based CFP‑10 detection can assist when CNS specimens are difficult to obtain. |
A16.2 | Respiratory TB, unspecified, without bacteriological or histological confirmation | Use when clinical suspicion exists but standard tests are non‑confirmatory; 0574U can aid diagnosis. |
R05 | Cough | Symptom code often present in patients evaluated with TB testing including 0574U. |
Related CPT Codes
| CPT Code | Description | Relationship to This Procedure |
|---|---|---|
81025 | Urinalysis, automated with microscopy | May be ordered concurrently for general infection workup and baseline renal assessment before TB therapy. |
87070 | Culture, bacterial; any other source except urine, blood or stool, aerobic | Sputum or other specimen cultures for Mycobacterium tuberculosis remain the diagnostic gold standard and are ordered alongside 0574U. |
87481 | Infectious agent detection by nucleic acid (eg, NAAT), Mycobacterium tuberculosis complex, amplified probe technique | Molecular testing for M. tuberculosis on respiratory specimens is commonly performed before or with the CFP‑10 assay to increase diagnostic sensitivity. |
G0480 | Drug screen, definitive, any number of drugs, technical component | Baseline or concurrent testing related to therapy monitoring or evaluation of co‑ingestions that may affect treatment choices (used variably in inpatient workflows). |
36415 | Collection of venous blood by venipuncture | Phlebotomy code for specimen collection used in the outpatient or inpatient setting prior to performing 0574U. |