TH-ZW216 Tianhe Portable Real-Time Fluorescent Quantitative PCR System for African Swine Fever Virus Detection

Overview

The TH-ZW216 is a compact, field-deployable real-time fluorescent quantitative PCR system engineered specifically for rapid, on-site nucleic acid detection of African Swine Fever virus (ASFV) in swine biological samples. It operates on the principle of sequence-specific amplification and fluorescence-based real-time monitoring of target DNA using TaqMan probe or SYBR Green I intercalating dye chemistry. Designed to meet the stringent operational requirements of veterinary diagnostic laboratories, mobile biosecurity units, and frontline agricultural inspection teams, the instrument complies with the regulatory framework established by the Ministry of Agriculture and Rural Affairs (MARA) of China—where only MARA-approved ASFV diagnostic kits (including配套 Tianhe’s ASFV Fluorescent PCR Detection Kit and ASFV Nucleic Acid Detection Kit) are authorized for official surveillance, slaughterhouse screening, and outbreak confirmation. Its dual-channel optical architecture supports simultaneous detection of ASFV and an internal control (e.g., porcine β-actin), enabling built-in assay validation and inhibition assessment per run.

Key Features

• Portable form factor (≤4.2 kg) with integrated battery option for uninterrupted operation in off-grid farm environments or transport vehicles.
• High-fidelity thermal cycling driven by Marlow-grade Peltier modules, coupled with PT1000 platinum resistance thermometers and active edge-resistive heating compensation—ensuring ±0.1 °C temperature accuracy and uniformity across all 16 wells.
• Full-plate fluorescence acquisition completed within 3 seconds per cycle, minimizing inter-well variability and supporting high reproducibility in low-template or degraded-field-sample contexts.
• Auto-adjusting pressure-sensitive heat lid eliminates condensation and ensures consistent seal integrity across varying tube types (0.2 mL single tubes or 8-tube strips).
• Capacitive touchscreen interface with intuitive workflow navigation; firmware supports offline protocol storage, user-defined program templates, and audit-trail-enabled session logging.
• No gradient function required—optimized for standardized MARA-validated ASFV assay protocols requiring uniform thermal profiles across all reaction vessels.

Sample Compatibility & Compliance

The TH-ZW216 accepts nucleic acid extracts from whole blood, serum, oral fluids, tissue homogenates, and environmental swabs processed via ISO 18593:2018-compliant or MARA-registered extraction kits. It is validated for use with Tianhe’s MARA-registered ASFV detection reagents (Registration Nos.兽药证书字2020XXXXX and 兽药证书字2021XXXXX), which conform to GB/T 38910–2020 (Nucleic Acid Detection Methods for African Swine Fever Virus). While not FDA 510(k)-cleared or CE-IVD marked, the platform meets GLP-aligned data integrity criteria: all runs generate timestamped, operator-identified .qpcr files with immutable cycle threshold (Ct), amplification efficiency, and melt peak metadata. Raw fluorescence data export (CSV/FCS) enables traceability during provincial veterinary bureau audits or MARA post-market surveillance reviews.

Software & Data Management

The embedded software provides full qPCR data analysis without external PC dependency. Core capabilities include automatic baseline determination, adaptive threshold setting, standard curve generation with R² ≥ 0.995, relative quantification (ΔΔCt), and multiplex channel overlay for co-amplified controls. All analyses retain original fluorescence trajectories and undergo checksum-verified export. Audit logs record user login, protocol selection, run initiation/completion timestamps, and manual parameter overrides—supporting alignment with MARA’s “Traceable Diagnostic Record” requirements under Notice No. 218 (2020). Data can be exported via USB to LIMS-compatible formats or synchronized to Tianhe Cloud (optional subscription) for centralized herd-level epidemiological dashboards.

Applications

• Routine surveillance testing in commercial pig farms, breeding nuclei, and boar stations under national ASF monitoring programs.
• Point-of-slaughter verification at licensed abattoirs prior to carcass release—integrated into HACCP-aligned food safety plans.
• Emergency response deployment during suspected outbreaks, enabling same-day confirmation without reliance on regional reference labs.
• Validation of cleaning-and-disinfection efficacy on fomites and transport vehicles via environmental sample screening.
• Parallel detection of other swine pathogens including Classical Swine Fever (CSFV), Porcine Reproductive and Respiratory Syndrome Virus (PRRSV), Pseudorabies Virus (PRV), and Avian Influenza Virus (AIV) using validated multiplex assays.

FAQ

Is the TH-ZW216 approved for official ASF diagnosis in China?

Yes—the instrument is deployed exclusively with MARA-registered Tianhe ASFV detection kits, fulfilling the mandatory requirement in MARA Announcement No. 302 (2020) for statutory testing in animal health supervision.
Can it be used without a laboratory infrastructure?

Yes—it operates on AC power or optional external LiFePO₄ battery packs (up to 4.5 h runtime), requires no external cooling, and functions reliably in ambient temperatures from 10–35 °C.
Does the software support 21 CFR Part 11 compliance?

No—its current configuration aligns with Chinese agricultural regulatory frameworks (MARA/GLP); Part 11 features (e.g., electronic signatures, role-based access control) are available only in enterprise-tier cloud-managed deployments.
What training is required for operators?

Users must complete Tianhe-certified training covering nucleic acid extraction fundamentals, contamination prevention, thermal profile validation, and interpretation of MARA-defined Ct cutoff thresholds (e.g., ≤38 for positive ASFV calls).
Is third-party reagent compatibility supported?

Only MARA-registered assays are validated for diagnostic use; non-Tianhe kits may function technically but void regulatory validity and quality assurance documentation.