Turtle ISO Digital Isothermal Amplification System
| Brand | Turtle |
|---|---|
| Origin | Shanghai, China |
| Manufacturer Type | Manufacturer |
| Product Category | Domestic |
| Model | ISO Digital |
| Sample Throughput | 1–12 samples (user-selectable) |
| Reaction Architecture | Fully Automated Digital Isothermal Amplification Platform |
| Droplet Generation Capacity | >20,000 droplets per run |
| Effective Droplet Yield | >95% |
| Droplet Uniformity | >99% |
| Quantification Method | Digital Endpoint Detection (dLAMP/dERA/dRPA compatible) |
| Run Time | 15–45 min |
| Automation Level | Integrated reagent mixing, droplet generation, incubation, and endpoint fluorescence imaging |
| Upgrade Path | Optional digital PCR (dPCR) module support |
Overview
The Turtle ISO Digital Isothermal Amplification System is an engineered platform for nucleic acid quantification based on digital partitioning and isothermal enzymatic amplification. Unlike thermal cycling–dependent methods such as conventional or quantitative PCR, the ISO Digital leverages constant-temperature amplification chemistries—including digital Loop-Mediated Isothermal Amplification (dLAMP), digital Enzymatic Recombinase Amplification (dERA), and digital Recombinase Polymerase Amplification (dRPA)—to deliver absolute quantification without thermocycling hardware. Its core architecture integrates microfluidic droplet generation, temperature-stabilized incubation, and high-sensitivity fluorescence imaging within a single benchtop footprint. Designed for reproducible molecular counting under controlled isothermal conditions (typically 60–65 °C), the system enables direct measurement of target copy number per microliter with Poisson-based statistical confidence—making it suitable for low-abundance target detection, rare variant analysis, and absolute calibration in clinical assay development.
Key Features
- Fully automated workflow: Integrated pipetting, oil–water phase separation, droplet generation, thermal incubation, and endpoint fluorescence acquisition eliminate manual intervention and inter-operator variability.
- Turtle Tech solid-phase oil–water interface technology: Enables robust generation of >20,000 monodisperse aqueous droplets per reaction, with >95% effective encapsulation efficiency and >99% size uniformity—critical for minimizing partitioning bias and ensuring statistical accuracy.
- FIFO (First-In, First-Out) timing control: Ensures identical reagent mixing duration and droplet formation latency across all samples in a batch, guaranteeing temporal consistency essential for comparative quantification.
- Modular throughput configuration: Supports 1–12 independent reactions per run, with individual thermal control and optical readout per channel to maintain cross-sample integrity.
- Scalable architecture: Field-upgradeable to full digital PCR capability via firmware update and optional optical calibration module—preserving capital investment while extending analytical scope.
Sample Compatibility & Compliance
The ISO Digital supports standard 200 µL PCR tubes and 8-strip tube formats, accommodating input volumes from 10–50 µL. It is validated for use with commercially available dLAMP, dERA, and dRPA master mixes, including those compliant with ISO/IEC 17025–accredited laboratory workflows. The system’s closed-tube operation minimizes contamination risk and aligns with CLIA-waived and IVDR pre-submission design principles. Audit trails, user access logs, and electronic signature support are embedded in the control software to facilitate compliance with FDA 21 CFR Part 11, GLP, and GMP documentation requirements where applicable.
Software & Data Management
The ISO Digital Control Suite provides intuitive graphical setup, real-time monitoring, and automated data processing—including droplet classification, fluorescence thresholding, positive/negative droplet enumeration, and Poisson-corrected concentration calculation. Raw image files (TIFF) and processed result tables (CSV/XLSX) are exportable with embedded metadata (date/time, operator ID, protocol version, instrument serial number). Software validation documentation (IQ/OQ protocols) is provided, and the platform supports LIMS integration via HL7 or RESTful API endpoints for enterprise-scale deployment.
Applications
- Ultra-sensitive pathogen detection in point-of-care and reference lab settings (e.g., SARS-CoV-2, HPV, MTB).
- Copy number variation (CNV) analysis and rare allele detection in liquid biopsy samples.
- Quantitative validation of NGS library preparation efficiency and adapter ligation yield.
- Reference material characterization and certified standard development per ISO Guide 34/35 requirements.
- Process analytical technology (PAT) implementation for biomanufacturing process monitoring.
FAQ
What isothermal chemistries are validated on the ISO Digital platform?
dLAMP, dERA, and dRPA chemistries are fully supported; users may also adapt other isothermal amplification formats with appropriate optimization of enzyme kinetics and probe design.
Does the system require external calibration standards for absolute quantification?
No—absolute quantification is intrinsic to the digital partitioning principle and relies only on Poisson statistics and measured droplet count; no standard curve is needed.
Can the ISO Digital be integrated into automated laboratory workflows?
Yes—via USB, Ethernet, or RS-232 interfaces, and through programmable command-line scripting (Python SDK available upon request).
Is the droplet generation process susceptible to surfactant carryover or cross-contamination?
No—the solid-phase oil–water separation technology eliminates emulsion instability and prevents carryover between runs; no post-run cleaning beyond standard surface wipe is required.
What regulatory documentation is supplied with the instrument?
CE marking (IVDR Class B), Declaration of Conformity, Factory Calibration Report, IQ/OQ Validation Templates, and Software Lifecycle Documentation are included in the delivery package.
