Autobio AutoLumo A2000Plus Fully Automated Chemiluminescence Immunoassay Analyzer
| Brand | Autobio |
|---|---|
| Model | AutoLumo A2000Plus |
| Origin | Henan, China |
| Manufacturer Type | Authorized Distributor |
| Domestic Product Classification | Yes |
| Throughput | 200 samples/hour |
| Sample Input Mode | Rotary Disc Loader |
| Sample Types Supported | Serum, Plasma, Whole Blood (with preprocessing), Urine |
| Reagent Loading | Continuous, On-the-Fly |
| Reaction Vessel Handling | Tipless, Inverted Cup Dispensing |
| Magnetic Separation Technology | High-Efficiency Dual-Stage Wash |
| Software Compliance | FDA 21 CFR Part 11–Ready Audit Trail, GLP/GMP-Compliant Data Archiving |
Overview
The Autobio AutoLumo A2000Plus is a fully automated, high-throughput chemiluminescence immunoassay (CLIA) analyzer engineered for clinical laboratory environments requiring robust, reproducible, and regulatory-compliant serological and hormonal testing. It operates on the principle of enzyme-labeled or acridinium ester–based chemiluminescent reactions, where antigen–antibody binding events trigger light emission quantified by a highly sensitive photomultiplier tube (PMT) under controlled thermal and optical conditions. Designed for continuous operation in mid-to-high volume laboratories, the system integrates microplate-based assay architecture with magnetic particle separation—enabling precise capture, washing, and signal detection across a broad panel of immunoassays. Its modular scalability (up to four units in parallel configuration) supports flexible throughput expansion without infrastructure overhaul, while its closed-system design minimizes operator intervention and environmental contamination risk.
Key Features
- Throughput of 200 tests per hour per module, scalable to 800 tests/hour in quad-module configuration
- Rotary disc sample loading with barcoded tube recognition and priority queue management for stat samples
- Tipless liquid handling architecture eliminates disposable pipette tips—reducing consumable cost and waste generation
- Inverted cup dispensing mechanism for reaction vessels: no manual cup alignment required; automated orientation and placement
- Continuous reagent and consumables loading during operation—no workflow interruption for reloading
- Dual-stage magnetic separation with optimized wash buffer kinetics, achieving <0.5% carryover and sub-100 cpm background noise
- Non-contact orbital shaking for uniform mixing—prevents cross-contamination and preserves bead integrity
- Integrated temperature-controlled incubation zones (37 °C ± 0.3 °C) with real-time monitoring and logging
Sample Compatibility & Compliance
The AutoLumo A2000Plus accepts primary tubes (13 × 75 mm, 16 × 100 mm) and microtiter plates (96-well format) for both routine and reflex testing. Compatible sample matrices include serum, lithium heparin or EDTA plasma, urine (diluted), and cerebrospinal fluid (CSF) following standardized preanalytical protocols. All assay protocols are developed and validated in accordance with CLSI EP12-A2 and ISO 15197:2013 guidelines. The instrument’s firmware and data management system support full traceability per ISO/IEC 17025:2017 and align with IVD regulatory requirements under China NMPA Class II/III registration (Registration No. 20223400123). Audit trail functionality complies with FDA 21 CFR Part 11 for electronic records and signatures, including user authentication, action timestamping, and immutable log archiving.
Software & Data Management
The AutoLumo Control Suite v4.2 provides a browser-based interface with role-based access control (RBAC), configurable dashboards, and real-time system status visualization. Critical software capabilities include predictive耗材 (consumables) inventory alerts with low-level notifications ≥72 hours before depletion; dynamic scheduling of STAT samples into active runs without pausing ongoing batches; and integrated result flagging (e.g., delta-check, reflex rule triggers) per LIS/HIS interface standards (HL7 v2.5.1, ASTM E1384). Raw luminescence counts, calibration curves, QC trends (Levey-Jennings, Westgard rules), and maintenance logs are exportable in CSV, PDF, or XML formats. Remote diagnostics and secure technician-assisted troubleshooting are enabled via TLS 1.2–encrypted channels with session recording for GLP audit readiness.
Applications
The platform supports over 80 CE-IVD–marked and NMPA-registered assays spanning infectious disease serology (HBV, HCV, HIV, syphilis, SARS-CoV-2 IgM/IgG), thyroid function (TSH, FT3, FT4, TPOAb), reproductive endocrinology (FSH, LH, prolactin, AMH), tumor markers (AFP, CEA, CA125, PSA), cardiac biomarkers (BNP, Troponin I), and autoimmune panels (ANA, ENA, dsDNA). Its precision profile—CVs ≤3.5% intra-run and ≤4.8% inter-day at medical decision points—meets CLIA ’88 and CAP accreditation requirements for moderate-complexity testing. The system is routinely deployed in tertiary hospitals, regional reference labs, and contract research organizations performing centralized clinical trial bioanalysis.
FAQ
What sample volumes are supported per test?
Minimum sample volume is 10 µL for most assays; up to 200 µL programmable for dilution-intensive analytes.
Does the system support bidirectional LIS/HIS integration?
Yes—HL7 ADT and ORU messages are fully configurable with acknowledgment feedback and error logging.
Is remote software update capability available?
Firmware and application updates are delivered via secure, signed packages through the AutoLumo Cloud Portal; all changes undergo version-controlled validation prior to deployment.
How is calibration and QC managed?
Calibrators and controls are barcode-scanned and auto-associated with lot-specific curves; QC results trigger automatic pass/fail evaluation against user-defined Westgard multirules.
What is the mean time between failures (MTBF) for core modules?
Based on field data from >1,200 installed units, MTBF exceeds 12,500 hours for the PMT detection unit and 8,200 hours for the magnetic separation station.
