Hengaode HAD-SK2 Rotational Platform Shaker for Syphilis Serology Assays (RPR/TRUST/VDRL) and Microplate Mixing

Overview

The Hengaode HAD-SK2 Rotational Platform Shaker is an engineered laboratory instrument designed specifically for standardized serological testing of syphilis—including Rapid Plasma Reagin (RPR), Toluidine Red Unheated Serum Test (TRUST), and Venereal Disease Research Laboratory (VDRL) assays—as well as general-purpose mixing of flat-format labware such as Petri dishes, multiwell plates, and microtiter plates. Its operation follows the principle of controlled orbital motion, generating uniform centrifugal acceleration across the platform to ensure consistent sample agitation without vortexing or splashing. The device complies with CLSI EP15-A3 guidelines for precision and reproducibility in clinical laboratory instrumentation and is routinely validated in ISO 15189-accredited diagnostic laboratories for routine serology workflows.

Key Features

• Transparent polycarbonate safety cover with integrated latch mechanism—prevents aerosol generation, liquid evaporation, and cross-contamination while enabling real-time visual monitoring.
• Four-quadrant anti-slip silicone mat with color-coded zones—facilitates spatial segregation of parallel samples within a single run, supporting traceability in batched clinical testing.
• Brushless DC motor drive system—ensures low acoustic noise (<45 dB(A)), zero maintenance, high torque stability at low speeds, and extended service life under continuous operation.
• Digital parameter control via front-panel keypad—enables precise setting of rotational speed (1 rpm increments) and duration (1-minute resolution), with non-volatile memory retention for user-defined protocols.
• Wide-input universal power supply (AC 100–240 V, 50/60 Hz)—eliminates need for voltage converters and maintains stable performance during grid fluctuations common in field or resource-limited laboratory environments.
• IP21-rated enclosure—provides protection against vertically falling solid objects and limited ingress of moisture, meeting IEC 60529 requirements for benchtop medical device safety.

Sample Compatibility & Compliance

The HAD-SK2 accommodates standard 35–150 mm Petri dishes, 6–96-well microplates (including deep-well and PCR plates), glass slides, and custom flat-bottom containers up to 2 kg total load. Its 22 mm orbit diameter delivers optimal mixing efficiency for viscous serological reagents and antigen-antibody suspensions, minimizing sedimentation artifacts during incubation phases. The instrument is compatible with CLIA-waived and moderate-complexity testing protocols under US FDA 21 CFR Part 866.2800 (in vitro diagnostics for syphilis). It supports GLP-compliant documentation when paired with external audit-trail-capable LIMS systems and satisfies essential requirements of ISO 17025:2017 clause 6.4.3 (equipment verification and calibration).

Software & Data Management

While the HAD-SK2 operates as a standalone hardware unit without embedded software, its digital interface enables seamless integration into regulated laboratory environments through external data capture. All operational parameters—including set speed, elapsed time, and active mode—are displayed in real time on the backlit LCD panel and can be logged manually or via RS-232/USB-connected data acquisition modules (optional). For 21 CFR Part 11 compliance, users may deploy third-party electronic lab notebook (ELN) platforms that record shaker usage metadata (e.g., operator ID, timestamp, protocol ID) alongside analytical results from associated immunoassay readers. Calibration records and preventive maintenance logs are maintained per manufacturer-recommended intervals (every 12 months or 1,000 operating hours).

Applications

• Clinical microbiology labs performing manual RPR, TRUST, or VDRL slide tests per CDC-recommended algorithms.
• Reference laboratories conducting proficiency testing and inter-laboratory comparison studies requiring high inter-run reproducibility.
• Research settings optimizing antigen coating uniformity on microplate surfaces prior to ELISA development.
• Biochemistry labs performing gentle resuspension of precipitated proteins or cell pellets in low-volume buffers.
• Quality control units validating lot-to-lot consistency of rapid diagnostic test kits under ISO 13485 manufacturing conditions.

FAQ

Is the HAD-SK2 compliant with ISO 15189 for clinical laboratory accreditation?

Yes—the mechanical design, repeatability performance (±1 rpm speed stability over 8-hour runs), and documented calibration traceability support alignment with ISO 15189:2022 clause 5.5.2 for equipment qualification.

Can the shaker accommodate 150-mm Petri dishes?

Yes—its 255 × 255 mm working surface provides ≥10 mm clearance margin around standard 150-mm dishes; maximum load remains 2 kg regardless of vessel size.

Does the transparent cover interfere with UV sterilization of the platform?

No—the polycarbonate cover is removable and autoclavable (up to 121°C, 15 min); UV-C exposure of the bare platform surface is permitted between uses.

What is the recommended calibration frequency?

Annual calibration using NIST-traceable tachometer and timer standards is advised; verification checks should occur before each daily shift in high-throughput diagnostic labs.

Is the device suitable for use inside a biosafety cabinet?

Yes—its low power draw (20 W), absence of heat-generating components, and compact footprint allow safe operation within Class II A2 cabinets without airflow disruption.