iFIND Fully Automated Molecular POCT System
| Brand | Rocgene |
|---|---|
| Origin | Beijing, China |
| Manufacturer Type | Original Equipment Manufacturer (OEM) |
| Model | iFIND |
| Automation Level | Fully Automated |
| Sample Types | Whole Blood, Urine, Cerebrospinal Fluid (CSF), Pleural Effusion, Ascites |
Overview
The iFIND Fully Automated Molecular POCT System is an integrated, benchtop nucleic acid testing platform engineered for rapid, closed-tube, point-of-care molecular diagnostics. Leveraging a synergistic architecture of microfluidics, lyophilized reagent cartridges, on-cartridge magnetic bead–based nucleic acid extraction, and real-time quantitative PCR (qPCR), the system executes end-to-end molecular analysis—from raw clinical specimen to validated, interpretable result—within 60 minutes. Unlike conventional laboratory-based PCR workflows requiring multiple manual transfers, centrifugation, pipetting, and thermal cycler handoffs, iFIND implements a true “Sample-in, Result-out” paradigm. All critical steps—including lysis, binding, washing, elution, reverse transcription (where applicable), amplification, and fluorescence detection—are physically confined within a single-use, injection-molded microfluidic cartridge. This eliminates open-tube handling, minimizes aerosol generation, and ensures biosafety compliance per WHO BSL-2 and CLSI MM19-A guidelines.
Key Features
- Fully automated operation: Single-step sample loading followed by one-button initiation; no user intervention required during processing.
- Closed-system workflow: Zero tube opening or reagent transfer post-sample introduction; integrated waste containment and aerosol barrier design.
- Modular throughput: Supports concurrent processing of 1–8 samples per run, with independent reaction chambers per sample to prevent cross-contamination.
- Pre-lyophilized assay cartridges: Each microfluidic unit contains vacuum-dried master mix, primers, probes, internal controls, and extraction reagents—eliminating cold-chain dependency and operator-induced pipetting error.
- MicroUnit sample processing technology: Patented capillary-driven fluidic control enables precise metering and sequential reagent delivery without external pumps or valves.
- Onboard thermal cycling and optical detection: Integrated Peltier-based thermocycling (±0.3°C uniformity) and LED–photodiode fluorescence detection across FAM/HEX/ROX channels.
Sample Compatibility & Compliance
The iFIND system accepts native, unprocessed clinical specimens including anticoagulated whole blood (EDTA/K₂EDTA), urine (centrifuged or uncentrifuged), cerebrospinal fluid (CSF), pleural effusion, and ascites—without pre-dilution or pre-filtration. Its liquid-sealed cartridge architecture prevents backflow and maintains hydrostatic isolation between processing zones. The platform complies with ISO 13485:2016 for medical device quality management systems and supports audit-ready data integrity per FDA 21 CFR Part 11 requirements, including electronic signatures, time-stamped audit trails, and immutable result archiving. It meets IEC 61010-1 safety standards and is CE-marked under IVDR Class D for high-risk in vitro diagnostic applications.
Software & Data Management
The embedded iFIND Control Software (v3.2+) provides intuitive touchscreen navigation, customizable test panels, and role-based user access control (administrator, technician, viewer). All runs generate encrypted .csv and PDF reports with full metadata: sample ID, operator, timestamp, cycle threshold (Ct), amplification curves, internal control status, and interpretation logic (e.g., positive/negative/indeterminate). Reports export via USB 3.0 or direct thermal printer interface (ESC/POS protocol). Raw fluorescence data and thermal profiles are stored locally with optional DICOM-SR or HL7 v2.5.1 integration for LIS/EHR interoperability. Audit logs record every user action, parameter change, and instrument event with tamper-proof hashing.
Applications
The iFIND system is deployed across diverse clinical and public health settings requiring rapid, reliable nucleic acid detection: hospital clinical microbiology and emergency departments (ED), intensive care units (ICU), outpatient clinics, centralized reference laboratories, national and provincial CDCs, port-of-entry quarantine facilities, veterinary diagnostic centers, companion animal hospitals, and agricultural biosecurity labs. Validated use cases include respiratory pathogen panels (e.g., SARS-CoV-2, influenza A/B, RSV), bloodstream infection markers (e.g., MRSA, Candida albicans), CNS infection diagnostics (e.g., HSV-1, EBV, enteroviruses in CSF), and zoonotic surveillance (e.g., avian influenza, African swine fever virus).
FAQ
What sample preparation is required prior to loading?
None—specimens are loaded directly into the cartridge inlet port in their native state. No centrifugation, dilution, or manual extraction is needed.
Can the system perform multiplex detection?
Yes—each cartridge supports up to 4-target multiplex qPCR assays with spectrally resolved detection across three fluorescent channels.
Is calibration or routine maintenance required?
No scheduled calibration is needed; the system performs daily self-diagnostic checks including optical baseline verification, thermal ramp validation, and fluidic integrity testing.
How is data security ensured during network transmission?
All network communications use TLS 1.2+ encryption; local storage employs AES-256 full-disk encryption compliant with HIPAA and GDPR technical safeguards.
Are assay cartridges stable at ambient temperature?
Yes—lyophilized reagents remain stable for ≥18 months at 2–30°C; no refrigeration or freezing is required for storage or transport.
