Norman CL211 Rapid Chemiluminescence Immunoassay Analyzer
The Norman CL211 is a rapid, benchtop chemiluminescence immunoassay (CLIA) analyzer designed for outpatient, emergency, and mid-sized labs, delivering results in 7 minutes for over 100 parameters at 60 tests/hour with 50 µL sample volume. It features magnetic particle CLIA technology, integrated sample track for hematology linkage, 10.4-inch touchscreen, unlimited result storage, and bi-directional LIS integration for efficient infectious disease, hormone, and tumor marker screening.
Description
Assay Methodologies: Versatile Immunoassay Detection The Norman CL211 utilizes magnetic particle-based chemiluminescent immunoassay (CLIA) for quantitative sandwich, competitive, and indirect assays, enabling sensitive detection of antigens and antibodies in serum, plasma, or whole blood. This rapid platform supports one-step reactions for accelerated workflows, ideal for time-critical testing like troponin for ACS or hCG for pregnancy confirmation, providing reliable results to guide immediate clinical decisions in ERs or primary care.
Parameters Measured: Supports over 100 assays across categories: infectious diseases (e.g., HBsAg, Anti-HBs, HCV Ab, HIV Ab/Ab combo, Syphilis TP), hormones (TSH, FT4, FSH, LH, Prolactin, Estradiol, Testosterone), tumor markers (CEA, AFP, CA125, CA19-9, PSA), cardiac markers (cTnI, CK-MB, Myo, NT-proBNP, D-Dimer), fertility (AMH, Inhibin B), and thyroid panels. Employs luminol-H2O2 chemiluminescence with PMT detection for ultra-low limits (e.g., 0.01 mIU/mL for TSH), with CV <5% and automated curve fitting for precise quantification, including flags for abnormal ranges.
Sample Requirements: Requires only 50 µL per test from serum, plasma, whole blood, or urine, minimizing patient discomfort in pediatric or frequent-monitoring scenarios. Compatible with primary tubes (5 mL) via auto-sampler rack (60 positions), supports barcode scanning for traceability, and allows whole blood direct testing when linked to hematology analyzers, reducing pre-processing steps.
Throughput: Processes up to 60 tests per hour with 7-minute assay times, tailored for labs handling 300–600 profiles daily. Continuous random access and STAT priority slots ensure <10-minute turnaround for urgent panels like thyroid or cardiac, while modular integration with chemistry/hematology systems expands to multi-parameter workflows without sample redraws.
Technology: Leverages magnetic particle separation for efficient washing and signal amplification via acridinium ester or luminol chemiluminescence, detected by high-sensitivity photomultiplier tubes (PMT) for dynamic range >6 logs. The integrated sample track enables seamless linkage to any hematology analyzer for combined CBC+IA on one sample, with automated pipetting, incubation (37°C), and data processing to minimize errors and support CLSI-compliant QC.
User Interface and Storage: Features a 10.4-inch color touchscreen with graphical dashboards, multilingual support (up to 8 languages, including English and Chinese), and one-touch protocols for user-friendly operation. Unlimited onboard storage for results, calibration curves, and QC logs with patient demographics; built-in thermal printer for reports, plus USB/LAN/RS232 for HL7 bi-directional LIS/HIS connectivity and PDF/CSV exports for EMR integration and audits.
Reagent System: Open system with dedicated 25-position reagent tray (2–8°C cooled, 24-hour stability) for magnetic particle kits, supporting bulk loading and low dead-volume dispensing (<20 µL) to cut costs by 30%. Auto-dilution for high samples, two-level QC, and expiry alerts ensure daily readiness, with compatibility for Norman’s ready-to-use reagents extending calibration to 28 days.
Dimensions and Portability: Compact benchtop design at 600 × 500 × 650 mm (W × D × H) weighs 45 kg, fitting standard lab benches or mobile units. Low power (≤300 VA) and quiet operation (<55 dB) suit 15–30°C ambient with 30–85% humidity, with optional casters for easy relocation in multi-room facilities.
- Throughput: 60 tests/hour
- Detection Channel: Multi-channel PMT for chemiluminescence.
- Detection Principle: Magnetic particle CLIA with sandwich/competitive formats.
- Detection Items: Over 100 parameters including infectious, hormones, tumor, cardiac markers; alarms for critical values.
- Built-in thermal printer, supports external printers. Multi-builtin report templates available.
- Unlimited sample results, including parameters, curves, QC data, and patient information.
- Sample modes: Serum/plasma, whole blood, urine; auto-sampling and hematology integration.
