Aliben PEC.A02 Offline Exhaled Breath Collector
| Brand | Aliben |
|---|---|
| Origin | Sichuan, China |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Regional Classification | Domestic (PRC) |
| Model | PEC.A02 |
| Price Range | USD 11,200 – 21,000 |
Overview
The Aliben PEC.A02 Offline Exhaled Breath Collector is a portable, non-invasive sampling device engineered for the standardized collection and stabilization of human exhaled breath volatiles in field, clinical, or home-based settings. It operates on a passive, bag-based offline collection principle—capturing breath samples directly into chemically inert, low-permeability Tedlar® or fluorinated ethylene propylene (FEP) gas sampling bags—enabling subsequent off-site analysis via time-of-flight mass spectrometry (TOF-MS), proton-transfer-reaction mass spectrometry (PTR-MS), or gas chromatography–mass spectrometry (GC-MS). Unlike online breath interfaces requiring real-time instrument coupling, the PEC.A02 decouples sample acquisition from analytical measurement, supporting logistical flexibility, multi-site cohort studies, and longitudinal monitoring without instrument downtime. Its design adheres to consensus guidelines for breath biomarker research—including the 2019 American Thoracic Society/European Respiratory Society (ATS/ERS) technical standards for breath sampling—and prioritizes minimal analyte adsorption, low blank interference, and consistent dead-space volume control.
Key Features
- Compact, handheld form factor (≤250 g, ≤180 mm × 85 mm × 45 mm) optimized for ambulatory use and transport under ISO 17025-compliant chain-of-custody protocols.
- Integrated microbial reduction system utilizing UV-C irradiation (254 nm) and optional replaceable antimicrobial filter media (e.g., silver-impregnated polypropylene) to suppress bacterial proliferation during storage—critical for preserving volatile organic compound (VOC) integrity over extended holding periods (up to 72 h at 4 °C).
- Intelligent sampling interface with real-time flow monitoring (thermal mass flow sensor, ±2% full-scale accuracy), breath-phase detection (via pressure differential thresholding), and automated end-expiratory trigger to exclude ambient air contamination.
- Rechargeable lithium-polymer battery providing ≥120 hours of standby operation or ≥300 discrete sampling cycles per charge—validated per IEC 62133 safety standards.
- Low-cost consumables architecture: compatible with industry-standard 1 L, 3 L, and 5 L gas-tight sampling bags; no proprietary cartridges or single-use electronics required.
- IP54-rated enclosure for dust and splash resistance, enabling reliable operation in non-sterile environments including outpatient clinics, epidemiological field sites, and domiciliary settings.
Sample Compatibility & Compliance
The PEC.A02 supports collection of exhaled breath from adult, pediatric, and geriatric subjects across diverse physiological states (e.g., fasting, post-prandial, exercise-induced). Sample bags are certified compliant with ASTM D5466 (standard practice for sampling of volatile organic compounds in ambient air) and ISO 16000-6 (indoor air—determination of volatile organic compounds). All wetted materials meet USP Class VI biocompatibility requirements and exhibit <0.1 ng/m³ background VOC emission (as measured by thermal desorption GC-MS per EPA TO-15 methodology). The system is compatible with GLP/GMP-aligned workflows and supports audit-trail generation when paired with validated LIMS integration modules.
Software & Data Management
Embedded firmware enables local storage of metadata—including date/time stamp, subject ID (barcode-scannable), ambient temperature/humidity (via onboard sensors), tidal volume estimate, and sampling duration—for export via USB-C or Bluetooth 5.0. Optional cloud-sync module (Aliben BreathLink™ v2.1) provides encrypted, HIPAA- and GDPR-compliant data transmission and supports 21 CFR Part 11–compliant electronic signatures and user access logging. Raw metadata exports conform to ISA-Tab and BRaHMS-compatible formats for interoperability with metabolomics platforms such as XCMS Online and MetaboAnalyst.
Applications
- Clinical biomarker discovery for pulmonary diseases (e.g., asthma, COPD, cystic fibrosis) and systemic conditions (e.g., diabetes mellitus, hepatic encephalopathy, early-stage lung cancer).
- Epidemiological screening in resource-limited or decentralized healthcare settings where centralized MS infrastructure is unavailable.
- Pharmacokinetic and pharmacodynamic studies assessing real-time metabolic response to inhaled therapeutics or environmental exposures.
- Home-based longitudinal monitoring of treatment adherence and disease progression using patient-operated sampling protocols.
- Method validation and reference material preparation for breath VOC reference standards (e.g., NIST SRM 2588).
FAQ
What breath volume does the PEC.A02 capture per cycle?
It collects a user-defined exhaled volume (typically 500–1500 mL) triggered at end-expiration, with adjustable tidal-volume gating thresholds.
Is the device compatible with both PTR-MS and GC-MS workflows?
Yes—its bag-based output interface meets inlet pressure and flow specifications for direct coupling to standard breath MS interfaces (e.g., Ionicon PTR-TOF 8000, Agilent 5977B GC-MSD) following appropriate bag conditioning and purge protocols.
Does it require calibration before each use?
No routine calibration is needed; however, annual verification of flow sensor accuracy against NIST-traceable standards is recommended per ISO/IEC 17025 Clause 6.5.
Can multiple samples be collected sequentially without bag replacement?
Each collection requires a new pre-evacuated sampling bag to prevent cross-contamination and ensure quantitative recovery; bag loading is tool-free and takes <15 seconds.
What regulatory certifications does the PEC.A02 hold?
CE marking (Class I medical device per MDR 2017/745 Annex VIII), RoHS 2011/65/EU compliance, and Sichuan Provincial Medical Device Registration Certificate (Registration No. SC2023XXXXX).
