TIANLONG Fascan 48E Real-Time Fluorescent Quantitative PCR System

Overview

The TIANLONG Fascan 48E Real-Time Fluorescent Quantitative PCR System is a compact, benchtop thermal cycler engineered for precision nucleic acid quantification and genotyping via fluorescence-based detection. It operates on the principle of real-time polymerase chain reaction (qPCR), integrating precise Peltier-based thermal control with multi-channel LED excitation and photodiode-based emission detection. Designed specifically for pharmacogenomic applications, the system supports endpoint and kinetic analysis of DNA amplification using hydrolysis probes (e.g., TaqMan), intercalating dyes (e.g., SYBR Green I), and ligation-based sequencing chemistries—including TIANLONG’s proprietary micro-sequencing assay platform for SNP detection. Its 48-well format enables efficient batch processing of clinical specimens such as whole blood, gastric mucosal biopsies, and buccal swabs, supporting rapid turnaround in molecular diagnostics laboratories adhering to ISO 15189 and CLIA-equivalent quality frameworks.

Key Features

• Precision thermal control architecture delivering ≤ ±0.3°C accuracy across the clinically critical 40–99°C range, with well-to-well temperature uniformity (CV ≤ 0.5%) ensuring high inter-run reproducibility.
• Four independent optical channels with discrete LED excitation (470 nm, 523 nm, 571 nm, 630 nm) and matched photodiode detection (525 nm, 564 nm, 612 nm, 670 nm), enabling simultaneous multiplex detection of FAM/SYBR Green I, VIC/HEX/TET/JOE, ROX/Texas Red, and Cy5-labeled targets.
• Maintenance-free solid-state LED illumination eliminates lamp degradation, reducing long-term calibration drift and operational downtime.
• Integrated 7-inch capacitive touchscreen interface with intuitive workflow navigation; also compatible with Windows-based desktop software for advanced protocol design, remote monitoring, and audit-ready data export.
• Optimized thermal ramping profiles support rapid cycling (≤ 1-hour total run time for standard 40-cycle assays), facilitating same-day reporting in pharmacogenomic testing workflows.

Sample Compatibility & Compliance

The Fascan 48E accepts standard 0.2 mL thin-wall transparent PCR tubes and 8-well strips, eliminating the need for proprietary consumables. It is validated for use with FDA-cleared and CE-IVD marked reagent kits—including TIANLONG’s companion micro-sequencing reagents for CYP2C9, VKORC1, CYP2C19, SLCO1B1, MTHFR, and other pharmacogenes. The system complies with IEC 61010-1 (Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use) and meets electromagnetic compatibility (EMC) requirements per IEC 61326-1. Software functionality supports ALCOA+ data integrity principles and includes user access controls, electronic signatures, and audit trail generation aligned with 21 CFR Part 11 readiness for regulated environments.

Software & Data Management

The Fascan Control Software provides modular experiment templates for genotyping, gene expression, and copy number variation analysis. It features automated baseline correction, threshold setting, Ct calculation, and allelic discrimination clustering. Raw fluorescence data (Rn values), amplification curves, melt curves, and allelic scatter plots are stored in vendor-neutral .csv and .fcs formats. All instrument operations—including method creation, run execution, and result review—are timestamped and logged with operator ID. Data encryption at rest and role-based permissions ensure compliance with GDPR and HIPAA-aligned data handling policies. Up to 1000 experiments can be archived locally; external backup via USB or network share is supported.

Applications

• Pharmacogenomic testing for warfarin, clopidogrel, statins, nitroglycerin, antihypertensives, aspirin, psychotropics, and folate metabolism-related variants.
• SNP genotyping using ligation-mediated micro-sequencing chemistry, enabling high-specificity discrimination of adjacent base substitutions.
• Quantitative detection of low-abundance biomarkers in liquid biopsy and tissue-derived DNA.
• Validation of NGS findings via orthogonal qPCR confirmation in clinical molecular pathology labs.
• Research-grade gene expression profiling in translational studies requiring moderate throughput and assay flexibility.

FAQ

Is the Fascan 48E compliant with 21 CFR Part 11 for use in regulated clinical laboratories?
Yes—the system’s software supports electronic signatures, audit trails, and user authentication protocols required for FDA-regulated environments when deployed with appropriate procedural controls.
Can the thermal block be replaced or upgraded to accommodate different well formats?
No—the Fascan 48E uses a fixed 48-well aluminum block optimized for 0.2 mL tubes and 8-well strips; it does not support interchangeable blocks.
What is the minimum detectable target concentration under standard assay conditions?
Under optimized primer-probe and template conditions, the system reliably detects targets at ≤ 10 copies per reaction with <5% inter-assay CV.
Does the instrument support high-resolution melt (HRM) analysis?
Yes—continuous fluorescence acquisition during controlled ramping (0.02–0.2°C/sec) enables HRM profiling for variant screening and methylation analysis.
Is remote monitoring or cloud-based data synchronization available?
Local network connectivity is supported for file transfer and status polling; however, native cloud integration is not embedded—data export must be performed manually via USB or LAN.