Norman CL2IIA Dual-Module Chemiluminescence Immunoassay Analyzer
The Norman CL2IIA is a dual-module, fully automated CLIA analyzer delivering 120 tests/hour with results in 7 minutes using 50 µL sample volume across 200+ parameters. Built for mid-to-large labs, it features magnetic particle chemiluminescence, dual-track hematology linkage, 10.4-inch touchscreen, unlimited storage, bi-directional LIS, and reagent auto-loading for seamless infectious, hormone, tumor, and cardiac marker testing.
Description
Assay Methodologies: Advanced Immunoassay Flexibility The Norman CL2IIA employs dual-module magnetic particle-based chemiluminescence (CLIA) with parallel processing for sandwich, competitive, and indirect immunoassays, enabling simultaneous high-throughput runs. This modular design supports rapid one-step reactions for urgent markers (e.g., cTnI, NT-proBNP) and extended panels (e.g., thyroid, fertility), providing high-sensitivity results to drive decisions in emergency, oncology, and endocrinology workflows.
Parameters Measured: Covers over 200 validated assays: infectious (HBsAg, Anti-HCV, HIV combo, CMV IgG/IgM), hormones (TSH, T3/T4, FSH, LH, β-hCG, AMH, Cortisol), tumor markers (CEA, AFP, CA15-3, CA125, PSA/fPSA, HE4), cardiac (cTnI, CK-MB, Myo, NT-proBNP, BNP, D-Dimer), inflammation (PCT, IL-6, CRP), and anemia (Ferritin, Folate). Uses acridinium ester luminescence with PMT detection for >7-log dynamic range (e.g., 0.005 pg/mL for cTnI), CV <4%, with AI-flagged outliers and multi-point calibration for precision in low-concentration or high-interference samples.
Sample Requirements: Aspirates 50 µL from serum, plasma, whole blood, urine, or CSF in 120-position dual racks (primary/secondary tubes), with barcode auto-ID and collision-free probe. Supports whole blood direct linkage to hematology analyzers for CBC+IA combo testing, auto-dilution (1:100), and STAT override, minimizing pre-analytics in high-volume or pediatric settings.
Throughput: Dual modules achieve 120 tests/hour (60/module) with 7-minute TAT, optimized for labs processing 1,000–2,500 tests daily. Continuous loading, parallel incubation (37°C × 2), and intelligent scheduling handle mixed panels (e.g., cardiac + thyroid) without delay, with <5-minute STAT results for critical care escalation.
Technology: Integrates dual magnetic separation units with high-luminance CLIA (acridinium ester) and dual PMT detectors for interference-free signal isolation. The hematology sample track enables seamless CBC+immunoassay on one draw, while robotic pipetting, auto-washing, and real-time QC monitoring ensure CLSI/ISO 15189 compliance. Built-in AI predicts reagent consumption and flags anomalies, reducing downtime.
User Interface and Storage: Equipped with a 10.4-inch high-resolution touchscreen featuring dual-module dashboards, real-time dual-curve visualization, and multilingual interface (up to 10 languages, including English, Spanish, and Arabic). Unlimited encrypted storage for results, calibration/master curves, Levey-Jennings QC, and audit trails; built-in thermal printer with customizable templates, plus USB/LAN/RS232/Wi-Fi for HL7/FHIR LIS/HIS integration and cloud backup.
Reagent System: 50 cooled positions (2–8°C, 24 h) across dual trays with auto-loading carousel for 25-test kits, using low-dead-volume (<15 µL) magnetic particle reagents. RFID auto-recognition manages inventory, expiry, and lot tracing; supports Norman’s ready-to-use packs with 28-day onboard stability, cutting waste by 35% and enabling weekly calibration.
Dimensions and Portability: Streamlined dual-module benchtop at 1,100 × 700 × 850 mm (W × D × H) weighs 120 kg, with modular expansion for future upgrades. Low power (≤600 VA) and quiet (<58 dB) operation suit 15–32°C ambient with 30–80% humidity, with lockable casters for multi-room deployment.
- Throughput: 120 tests/hour (dual module)
- Detection Channel: Dual PMT with independent magnetic separation.
- Detection Principle: Magnetic particle chemiluminescence (acridinium ester) in sandwich/competitive formats.
- Detection Items: 200+ parameters (infectious, hormones, tumor, cardiac, inflammation); critical alarms and AI flags.
- Built-in thermal printer, supports external printers. Multi-builtin report templates available.
- Unlimited sample results, including parameters, dual curves, QC trends, and patient information.
- Sample modes: Serum/plasma, whole blood, urine, CSF; dual-track hematology integration and auto-dilution.
