Modular Automated Urinalysis System

What is the Modular Automated Urinalysis System?

A modular urinalysis system consists of a chemistry module and a sediment module that can operate together or independently, sharing one middleware layer. It suits laboratories that want to add sediment analysis later or keep one module running during maintenance.

Overview

Each module has its own sample loader, analytical components and waste handling, and the middleware merges results into one report, applies review rules and manages quality control for both. Because the modules are independent, the laboratory can start with chemistry only and add the sediment module when volume justifies it, and one module can continue working while the other is serviced. Sample routing between modules is by a short transfer mechanism or by manual transfer for small installations, and the middleware assigns the same sample identifier to both results. Workflow planning should account for the fact that two modules have separate reagent inventories, maintenance schedules and quality control requirements.

How does it work?

The platform links two analytical modules through one sample and one worklist. The chemistry module dips a reagent strip, reads the pads by reflectance photometry at defined wavelengths, applies colour and ascorbate compensation and reports semiquantitative categories. The sediment module either uses flow cytometry with a nucleic acid stain and scatter signals to classify particles by size, granularity and fluorescence, or images a sediment chamber or centrifuged slide and classifies particles by pattern recognition. The software merges both result sets into one report, applies review rules such as reflex microscopy for flagged samples, and transmits results to the laboratory information system. Sample barcode reading, mixing before aspiration and automatic washing between samples reduce operator handling and improve traceability, while quality control records and reagent lot tracking support accreditation.

What are the key features?

• Independent chemistry and sediment modules with shared middleware
• Merged report with one sample identifier per patient
• Ability to add the sediment module after initial installation
• Continued operation of one module during service of the other
• Separate reagent inventories tracked centrally
• Review rules applied consistently across both modules

What are the technical specifications?

A typical modular automated urinalysis system configuration offers modules of Chemistry module plus sediment module, throughput per module of Chemistry 120–200 strips/h; sediment 60–120 samples/h, sample transfer of Short transfer mechanism or manual transfer, middleware functions of Result merging, review rules, quality control, sample volume of 1–3 mL shared; 0.5 mL minimum per module and data storage of 50,000 records across the system. Values are indicative of the product class; the exact figures for each configuration are confirmed on the quotation and the calibration documents supplied with the instrument.

Which applications is it used for?

The Modular Automated Urinalysis System is used in laboratories adding sediment analysis in stages, sites needing partial redundancy, outpatient laboratories with separate chemistry and microscopy workstations and laboratories standardising review rules across modules. Across the wider Automated Urinalysis Systems class, laboratories also deploy it for hospital routine urinalysis with combined reporting, nephrology and urology outpatient testing and emergency department urine screening.

Which standards and certifications apply?

Relevant standards and methods include ISO 15189, CLSI GP16, CLSI EP05, CLSI AUTO10, CLSI POCT04, IEC 61010-1 and IEC 61010-2-101. Certification candidates for this model are CE, ISO 13485 manufacturing and NMPA class II registration; each is to be confirmed for the specific configuration before shipment, and certificates are supplied only where they have been issued.

Install the system on a level bench with controlled temperature, stable power and enough space for reagent and waste containers, and verify each module separately before validating the combined workflow with a set of normal and abnormal samples compared against manual microscopy. Define the review rules and test them before go-live, since rule errors affect which results are released automatically. Daily work includes running chemistry control strips and sediment control material, checking reagent and strip status and inspecting the flow cell or imaging chamber for deposits. Wash solutions, cuvettes and flow cells require scheduled cleaning, and results flagged by the system should be reviewed according to documented criteria. Treat all urine samples and waste as potentially infectious.

How do I select the right Modular Automated Urinalysis System?

Choose a modular configuration when budget or space must be spread over time, or when the ability to keep chemistry running during sediment module maintenance is important. In the RFQ confirm that both modules can be supplied with one middleware licence, the expected transfer time between modules, and how reagent and quality control data are presented in one record set.

How does it compare with other Automated Urinalysis Systems variants?

Choose an automated urinalysis system when sediment results are required routinely and the daily sample number exceeds a few hundred, or when manual microscopy cannot keep up with the workload. Compare systems by which sediment technology is used, the particle classes reported, whether a microscope image is available for review, and the review rules offered. Check the chemistry parameters, cross-contamination control between samples, barcode handling and the combined report format. Confirm the throughput on a realistic mixture of normal and abnormal samples, since flagged samples take longer, and the sample volume needed for both modules. Verify LIS integration and the traceability features, and plan a downtime procedure because a single platform carries both chemistry and sediment reporting.