Norman FIA-1000 Fluorescence Immunoassay Analyzer
The Norman FIA-1000 is a portable, one-channel fluorescence immunoassay (FIA) analyzer providing quantitative results in 3–15 minutes for over 100 parameters at up to 60 tests/hour with 50 µL sample volume. Tailored for small clinics and labs, it features time-resolved fluorescence (TRF) detection, 7-inch touchscreen, 50,000-result storage, built-in printer, and bi-directional LIS integration for efficient screening of infectious diseases, hormones, and cardiac markers.
Description
Assay Methodologies: Quantitative Fluorescence Detection The Norman FIA-1000 uses time-resolved fluorescence immunoassay (TRF-FIA) for competitive and sandwich formats, enabling precise antigen-antibody binding detection with europium-labeled tracers. This minimizes background noise for high sensitivity, supporting rapid qualitative/quantitative assays ideal for point-of-care (POCT) decisions like confirming infections or monitoring hormones, delivering actionable data in resource-limited settings without full lab infrastructure.
Parameters Measured: Supports over 100 assays including infectious markers (HBsAg, Anti-HCV, HIV Ab, Syphilis TP, Dengue NS1/IgM/IgG), hormones (TSH, FT4, FSH, LH, Prolactin, β-hCG), cardiac (cTnI, CK-MB, Myo, NT-proBNP, D-Dimer), tumor (CEA, AFP, CA125, PSA), inflammation (CRP, SAA, PCT), and fertility (AMH). Employs 365 nm excitation and 610 nm emission for >5-log dynamic range (e.g., 0.01 mIU/mL for TSH), with CV <8% and automated calibration curves for reliable quantification across low/high ranges.
Sample Requirements: Aspirates 50 µL from serum, plasma, whole blood, or urine using disposable test cards (cassettes), compatible with fingerstick capillary or venous draws for minimal invasiveness in pediatrics or field use. Barcode scanning on cards ensures traceability, with no pre-treatment needed for most assays, reducing errors in on-site testing.
Throughput: Processes up to 60 tests per hour in single-channel mode, suited for small clinics handling 200–500 tests daily. Each assay completes in 3–15 minutes (incubation-dependent), with continuous card insertion for walk-away operation during shifts, prioritizing STAT like cardiac troponin for ER triage.
Technology: Leverages TRF technology with LED excitation and PMT detection for long-lived fluorescence signals (>1 ms decay), eliminating short-lived autofluorescence. The portable incubator maintains 37°C for consistent reactions, while integrated optics and software auto-calibrate against standards, aligning with CLSI POCT guidelines for accuracy in non-lab environments.
User Interface and Storage: Integrates a 7-inch color touchscreen with intuitive menus, graphical result displays, and multilingual support (up to 6 languages, including English and Chinese) for easy training. Stores 50,000 results with parameters, curves, patient IDs, and QC logs in a searchable database; built-in thermal printer for on-demand reports, with USB/RS232 for LIS connectivity and PDF/CSV exports to support digital records.
Reagent System: Uses disposable test cards with pre-loaded, dry fluorescent reagents (europium chelates), stored at room temperature for 18 months or 2–8°C for extended stability. No liquid handling required, minimizing waste; auto-recognition via QR codes on cards tracks lot/expiry, with built-in controls for daily verification to ensure 100% readiness.
Dimensions and Portability: Ultra-portable design at 210 × 240 × 135 mm (W × D × H) weighs <5 kg, fitting in briefcases for mobile clinics or bedside use. Battery-powered (up to 8 hours) with AC adapter option, operates quietly (<45 dB) in 10–40°C ambient with 20–90% humidity, ideal for remote or primary care deployment.
- Throughput: Up to 60 tests/hour
- Detection Channel: Single-channel PMT for fluorescence.
- Detection Principle: Time-resolved fluorescence immunoassay (TRF-FIA) in competitive/sandwich formats.
- Detection Items: Over 100 parameters (infectious, hormones, cardiac, tumor, inflammation); alarms for critical thresholds.
- Built-in thermal printer, supports external printers. Multi-builtin report templates available.
- 50,000 sample results, including parameters, calibration curves, QC data, and patient information.
- Sample modes: Serum/plasma, whole blood, urine; card-based auto-insertion.
