Waters ACQUITY UPLC I-Class PLUS / Xevo TQ-S cronos System

Overview

The Waters ACQUITY UPLC I-Class PLUS / Xevo TQ-S cronos System is a fully integrated ultra-high-performance liquid chromatography–tandem mass spectrometry (UHPLC-MS/MS) platform co-branded by Waters Corporation and KHB (Shanghai Kehua Bio-Engineering Co., Ltd.). Engineered specifically for high-throughput clinical diagnostics laboratories, this system combines Waters’ industry-proven ACQUITY UPLC I-Class PLUS separation module—featuring low-dispersion flow paths, sub-2-µm particle column compatibility, and nanogram-level injection precision—with the Xevo TQ-S triple quadrupole mass spectrometer, renowned for its robust ion transmission, high duty cycle, and quantitative reproducibility across dynamic concentration ranges. The system operates on the principle of electrospray ionization (ESI) or atmospheric pressure chemical ionization (APCI), followed by mass-selective fragmentation in Q2 and detection in Q3, enabling highly selective multiple reaction monitoring (MRM) assays essential for small-molecule quantitation in complex biological matrices such as serum, plasma, urine, and dried blood spots.

Key Features

• UHPLC Module: ACQUITY UPLC I-Class PLUS with binary solvent manager, integrated sample manager-FTN, and column oven supporting temperature control from 5 °C to 90 °C; maximum operating pressure up to 1300 bar.
• Mass Spectrometer: Xevo TQ-S triple quadrupole MS with StepWave ion optics, enhanced sensitivity for low-abundance analytes, and fast polarity switching (< 20 ms) for simultaneous positive/negative mode analysis.
• System Integration: Pre-validated hardware and firmware coupling between UPLC and MS ensures seamless synchronization, reduced method transfer time, and minimized downtime during routine operation.
• Robust Architecture: Designed for 24/7 clinical laboratory environments with redundant pump systems, automatic leak detection, and intelligent diagnostic logging accessible via UNIFI SIS dashboard.
• Regulatory-Ready Design: Includes audit trail, electronic signatures, and user access controls aligned with FDA 21 CFR Part 11, ISO/IEC 17025, and CLIA requirements.

Sample Compatibility & Compliance

The cronos system accommodates a broad range of clinical sample types—including anticoagulated whole blood, centrifuged plasma (EDTA, heparin, citrate), serum, urine, cerebrospinal fluid (CSF), and tissue homogenates—following standardized protein precipitation, solid-phase extraction (SPE), or liquid–liquid extraction (LLE) workflows. All hardware components comply with IEC 61010-1 safety standards and electromagnetic compatibility (EMC) directives (EN 61326-1). Method validation packages support adherence to CLSI EP26-A, USP , and ISO 15189:2022 clauses related to measurement uncertainty, specificity, and intermediate precision. Routine performance verification follows daily tuning and weekly calibration protocols traceable to NIST-certified reference materials.

Software & Data Management

UNIFI Scientific Information System serves as the unified software environment for instrument control, data acquisition, processing, and reporting. It provides template-driven assay setup, automated peak integration using retention time alignment and spectral deconvolution algorithms, and configurable report generation compliant with HL7 and ASTM E1384 standards. The system supports role-based user permissions, full audit trail recording (including parameter changes, reprocessing events, and result approvals), and secure data archiving with optional integration into LIMS via RESTful APIs. Electronic signature functionality meets ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) required under GxP-regulated environments.

Applications

This platform is routinely deployed in clinical toxicology (e.g., opioid panel screening, benzodiazepine quantification), endocrinology (cortisol, testosterone, vitamin D metabolites), newborn screening (acylcarnitines, amino acids), therapeutic drug monitoring (tacrolimus, sirolimus, vancomycin), and metabolic disorder diagnostics (organic acidemias, lysosomal storage diseases). Its MRM transition specificity and low ng/L limit of quantitation enable reliable detection in multiplexed assays containing >50 analytes per run, with cycle times under 1.2 seconds—critical for maintaining throughput in high-volume reference labs.

FAQ

Is the cronos system validated for use in CAP-accredited laboratories?
Yes—the system’s hardware configuration, UNIFI SIS software modules, and associated IQ/OQ/PQ documentation packages are designed to meet CAP checklist requirements for mass spectrometry-based clinical testing.
Can existing UPLC or Xevo TQ-S methods be transferred directly to the cronos platform?
Method portability is supported through UNIFI’s cross-platform method import utility; minor adjustments to dwell time or collision energy may be required depending on column dimensions and mobile phase composition.
Does the system support GLP-compliant study execution?
While primarily optimized for clinical diagnostics, the system’s 21 CFR Part 11–enabled software architecture and full audit trail functionality allow adaptation for non-clinical GLP studies when paired with appropriate SOPs and validation documentation.
What level of technical support is available outside North America?
KHB provides localized service coverage across mainland China, including field engineer deployment, preventive maintenance contracts, and remote diagnostics via Waters’ global support infrastructure.