ZiQi ZQTP-DI & ZQTP-DII Circular Orbital Shaker for Serological Assays (Syphilis Testing)

Overview

The ZiQi ZQTP-DI and ZQTP-DII Circular Orbital Shakers are precision-engineered laboratory instruments designed specifically for standardized serological agglutination assays—particularly the Rapid Plasma Reagin (RPR), Toluidine Red Unheated Serum Test (TRUST), and Venereal Disease Research Laboratory (VDRL) tests used in syphilis screening and confirmation workflows. These shakers operate on a fixed 22 mm circular orbit, delivering consistent, low-shear orbital motion optimized for uniform mixing of serum-antigen suspensions in shallow-well plates, glass slides, or Petri dishes without foaming or sample splashing. Unlike generic platform shakers, the ZQTP series incorporates clinical assay-specific mechanical calibration, ensuring reproducible rotation kinetics required by CLSI EP12-A2 and ISO 15197–aligned protocols. The system’s brushless DC motor provides stable torque across the full 40–350 rpm range, eliminating electromagnetic interference that could compromise adjacent sensitive instrumentation (e.g., ELISA readers or microplate luminometers). Its compact benchtop footprint and dual-configurable platform—open-frame (ZQTP-DI) and transparent polycarbonate shielded (ZQTP-DII)—support both high-throughput batch processing and biosafety-compliant handling of potentially infectious specimens.

Key Features

• Orbital motion with precisely controlled 22 mm diameter path—engineered to meet kinetic requirements of RPR/TRUST/VDRL slide-based assays per CDC and WHO syphilis testing guidelines.
• Brushless DC motor drive ensures silent operation (20,000 h MTBF), and zero EMI emission—critical in shared diagnostic lab environments.
• Independent digital control of speed (40–350 rpm, ±1 rpm resolution) and time (1 min to 19 h 59 min, ±10 s accuracy) via intuitive LCD interface with real-time parameter feedback.
• ZQTP-DII variant includes a removable, autoclavable polycarbonate safety shield (IP21 rated) with integrated four-zone anti-slip silicone mat—enabling spatial segregation of parallel assay batches while minimizing aerosol generation and solvent evaporation.
• Universal AC input (100–240 V, 50/60 Hz) with active voltage regulation safeguards against line fluctuations common in resource-constrained clinical settings.
• Integrated oscillation brake halts motion within <0.5 s upon lid opening or emergency stop—complying with IEC 61010-1 Clause 7.3.2 for operator protection during plate handling.

Sample Compatibility & Compliance

The ZQTP-DI/DII accommodates standard diagnostic formats including 12- to 72-well glass/slides, 96-well microplates (flat-bottom only), Petri dishes (up to Ø150 mm), and custom assay trays with total load ≤2 kg. Its open-platform (ZQTP-DI) supports rapid plate exchange in high-volume labs; the shielded ZQTP-DII meets WHO Laboratory Biosafety Manual (3rd ed.) recommendations for Level 2 containment when processing human serum specimens. The unit conforms to IEC 61010-1:2010 (Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use), EMC Directive 2014/30/EU, and RoHS 2011/65/EU. While not FDA-cleared as an IVD device, its performance parameters align with CLSI EP12-A2 verification criteria for qualitative immunoassay shakers and support GLP-compliant recordkeeping when paired with external audit-trail-capable software.

Software & Data Management

The ZQTP series operates as a standalone hardware platform with no embedded firmware-based data logging. All operational parameters—including start time, set rpm, duration, and mode—are displayed in real time on the front-panel LCD but are not stored internally. For regulatory traceability (e.g., ISO 13485 or CAP-accredited labs), users must integrate external timestamped documentation: manual logbooks, LIMS-triggered event capture, or third-party USB-connected data loggers compliant with FDA 21 CFR Part 11 (electronic signatures, audit trails, and data integrity controls). The shaker’s analog-compatible control signals (0–5 V TTL output optional upon request) permit synchronization with automated assay workstations or PLC-controlled lab automation systems.

Applications

• Routine syphilis serology: RPR, TRUST, and VDRL slide agglutination assays per CDC MMWR guidelines.
• Antibody titration workflows requiring precise endpoint determination under standardized agitation kinetics.
• Uniform resuspension of latex or carbon particle reagents in rapid diagnostic test (RDT) development and QC.
• Low-shear mixing of cell cultures in suspension-mode assays where centrifugal force must remain below 0.5 × g.
• Pre-incubation homogenization of antigen-coated microtiter plates prior to ELISA or lateral flow strip assembly.

FAQ

Is this instrument FDA-cleared for clinical diagnostics?
No. The ZQTP-DI/DII is classified as a general-purpose laboratory shaker. It is not an FDA-listed IVD device, nor does it carry CE-IVD marking. Its use in regulated clinical testing must be validated per local regulatory requirements (e.g., CLIA, CAP, or national health authority protocols).

Can the ZQTP-DII shield be sterilized?
Yes. The polycarbonate shield is autoclavable at 121 °C for 15 minutes (max. 20 cycles recommended). Avoid chemical sterilants containing phenols or strong oxidizers to prevent surface crazing.

What is the maximum allowable ambient temperature for continuous operation?
The unit is rated for uninterrupted operation at ambient temperatures up to 50 °C, provided relative humidity remains ≤80% RH and ventilation grilles are unobstructed.

Does the shaker support external triggering or remote control?
Standard units feature only front-panel operation. Optional TTL-compatible trigger input (0–5 V) and analog speed control interface are available under OEM configuration—contact technical support for part number and integration documentation.

How is compliance with ISO/IEC 17025 verified during installation qualification?
IQ/OQ documentation packages—including factory-calibrated speed verification reports (traceable to NIST standards), mechanical stability test records, and electrical safety certificates—are provided with each shipment. On-site performance qualification requires user-defined acceptance criteria aligned with assay-specific rotational uniformity thresholds (e.g., ±3 rpm deviation across full load range).