TIANLONG Panall 8000 Integrated Nucleic Acid Extraction and Real-Time Fluorescent PCR System
| Brand | TIANLONG |
|---|---|
| Origin | Shaanxi, China |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Product Category | Domestic |
| Model | Panall 8000 |
| Instrument Type | Real-Time Quantitative PCR System |
| Sample Throughput | 1–8 samples |
| Modular Exchangeability | Not supported |
| Effective Reaction Volume Range | Max sample volume ≤ 2/3 of tube capacity |
| Heating Rate | Avg ≥ 4.5°C/s |
| Cooling Rate | Avg ≥ 3.5°C/s |
| Temperature Uniformity | ±0.2°C across wells |
| Temperature Accuracy | ≤ ±0.1°C |
| Temperature Control Precision | ≤ ±0.1°C |
| Detection Channels | 4 |
| Light Source | High-Stability LED Array |
| Detection Sensitivity | 99.99% (based on validated assay performance under ISO 13485-controlled manufacturing) |
| Software Compliance | Supports audit trail, user access control, and electronic signature per FDA 21 CFR Part 11 requirements for regulated laboratories |
Overview
The TIANLONG Panall 8000 Integrated Nucleic Acid Extraction and Real-Time Fluorescent PCR System is an automated, closed-tube molecular diagnostic platform engineered for precision, reproducibility, and workflow consolidation in clinical microbiology, public health, and research laboratories. It integrates magnetic-bead-based nucleic acid isolation with real-time quantitative polymerase chain reaction (qPCR) amplification and detection in a single instrument enclosure—eliminating manual transfer steps between extraction and amplification modules. The system operates on the principle of solid-phase paramagnetic particle binding under controlled buffer chemistry and magnetic field gradients, followed by thermal cycling using Peltier-based thermoelectric modules and optical detection via four independently calibrated LED-excitation/photodiode-emission channels. Designed to meet ISO 15189 and CLIA-equivalent operational standards, the Panall 8000 supports “sample-in, result-out” workflows for pathogen identification, viral load quantification, and multi-target syndromic testing without cross-contamination risk.
Key Features
- Single-platform integration of sample tube opening/closing, precise liquid handling (20–250 µL), magnetic bead-based nucleic acid purification, reaction setup, and real-time fluorescent qPCR amplification.
- Eight-sample throughput with four-color fluorescence detection (FAM/SYBR Green I, VIC/HEX/TET/JOE, ROX/Texas Red, Cy5), enabling up to 24 distinct genetic targets per sample via multiplexed assay design.
- Proprietary rotational mixing technology (Patent No. ZL201710435931.8) replaces conventional vortexing or shaking—reducing aerosol generation by >90% compared to oscillatory methods and minimizing false-positive risk from carryover contamination.
- Integrated biosafety architecture: directional airflow management between sample processing and amplification zones; programmable negative-pressure chamber control; dual UV-ozone lamps with automatic post-run sterilization cycle; HEPA-filtered exhaust (H13 grade, ≥99.95% efficiency at 0.3 µm).
- Intuitive touchscreen interface with spatially mapped experiment layout—software auto-detects tube placement on deck and validates reagent strip orientation; visual alerts flag misloaded consumables with red-highlighted icons in real time.
Sample Compatibility & Compliance
The Panall 8000 accepts standard 0.2 mL PCR tubes and proprietary magnetic bead-based extraction kits validated under TIANLONG’s ISO 13485-certified manufacturing system. It complies with IEC 61010-1:2010 for laboratory equipment safety and meets electromagnetic compatibility (EMC) requirements per EN 61326-1:2013. For regulatory environments, the system supports GLP/GMP-aligned data integrity through built-in 2D barcode scanning for sample tracking, vision-based reagent lot verification, and immutable audit logs—including timestamps, operator IDs, parameter changes, and instrument status events. All firmware and software revisions are traceable and documented per ISO 14971:2019 risk management protocols.
Software & Data Management
The embedded Linux-based operating system runs TIANLONG’s proprietary PanallControl™ software, featuring role-based user authentication (admin, technician, viewer), customizable assay templates, and dynamic threshold setting for Ct value calculation. Data files—including raw fluorescence curves, melt profiles, and QC metrics—are stored locally (up to 1,000 experiments) and exportable in CSV, PDF, and RDML v1.2 formats. Network connectivity via Gigabit Ethernet (TCP/IP) enables HL7-compatible LIS/HIS integration and remote monitoring. Electronic signatures, session lockout after inactivity, and full 21 CFR Part 11 compliance—including audit trail encryption and non-repudiation safeguards—are enabled by default in clinical deployment configurations.
Applications
The Panall 8000 is routinely deployed in hospital central labs for rapid detection of respiratory pathogens (e.g., SARS-CoV-2, influenza A/B, RSV), gastrointestinal panels (Norovirus, Rotavirus, Salmonella), and bloodstream infection markers (MRSA, VRE, Candida spp.). Its multiplex capability supports syndromic testing across neurological, urogenital, and immunocompromised patient cohorts. In reference laboratories, it serves as a confirmatory platform for antimicrobial resistance gene profiling (e.g., mecA, vanA, blaKPC) and oncology biomarker screening (e.g., EGFR L858R, BRAF V600E). Method validation studies demonstrate linearity (|r| ≥ 0.998), inter-run CV ≤ 1.5% for Ct values, and LOD consistent with CLSI EP17-A2 guidelines.
FAQ
Is the Panall 8000 compatible with third-party reagents?
The system is optimized for use with TIANLONG’s CE-IVD and NMPA-registered magnetic bead extraction kits and qPCR master mixes. While open-channel configuration allows manual protocol adaptation, full performance validation—including sensitivity, specificity, and reproducibility—is only guaranteed with TIANLONG-validated consumables.
What maintenance intervals are recommended?
Daily decontamination using 70% ethanol is required for external surfaces; HEPA filters must be replaced every 6 months or after 500 cycles; UV lamps are rated for 5,000 hours and should be verified quarterly with radiometric dosimetry.
Does the system support remote diagnostics or firmware updates?
Yes—via secure HTTPS-enabled web portal with TLS 1.2 encryption. Firmware updates require signed digital certificates and undergo SHA-256 hash verification prior to installation.
Can the Panall 8000 be integrated into a laboratory information system (LIS)?
It supports ASTM E1384-compliant bidirectional HL7 v2.5.1 messaging for order entry, result reporting, and status notifications, including rejection flags and QC failure codes.
What environmental conditions are required for stable operation?
Ambient temperature: 10–30°C; relative humidity: 35–70% RH (non-condensing); atmospheric pressure: 86.0–106.0 kPa; power supply: AC 220 V ±10%, 50 Hz, 1200 VA maximum load.
