The document discusses the evolution and advancements in automated urinalysis technology, highlighting the transition from manual to automated processes to improve accuracy, efficiency, and turnaround time in laboratories. It details different types of automated instruments, including semi-automated and fully automated systems, as well as their integration with laboratory information systems and adaptations for various testing environments. The text also explores innovations like smartphone-based dipstick readers and automated microscopy analyzers that enhance analysis and reduce human error in urinalysis.

1. AUTOMATED URINALYSIS
The automation of laboratory assays - rapidly progressed during the recent past to standardize
procedures, streamline efficiency, minimize cost and turnaround time.
Automated instruments interfaced with laboratory information systems (LIS), facilitating reporting and result
retrieval, quality control and quality assurance. The automation of urinalysis early 1980s.
Partially or completely automated instruments that read urine reagent strips and measure the
physical properties of urine. Automated urinalysis technology is dynamic, with new instruments and
improved versions of current instruments. Several instruments are available to automate the macroscopic
evaluation and chemical component of the routine urinalysis.
These instruments include compact, portable, semi-automated and fully automated dipstick
readers designed for point-of- care (POC) testing in the emergency department, intensive care wards,
physician offices, clinics, higher throughput designed for central clinical laboratories.
These instruments improve the accuracy and reproducibility, eliminates subjective error by visual
interpretation of the color change.
Most also flag abnormal findings, store previous results, print results, and include an
interface to an electronic health record system that eliminates the error associated with manual result
transcription.
Automated reagent strip analyzers were first introduced in 1972, Japan. However, all
automated reagent strip analyzers utilize the principle of reflectance photometry to measure the color
intensity of the reaction pads of the dipstick.
An object illuminated by an incident light source absorbs some of the light and scatters the remaining light
(termed diffuse reflectance) in all directions.
Nearly all automated reagent strip readers provide measurements of urine leukocyte,
nitrite, protein, blood, glucose, ketone, bilirubin, urobilinogen, pH, specific gravity, and color.
Measurements of microalbumin, creatinine, PCR, ACR, and/or urine human chorionic gonadotropin (hCG)
may also be available from some manufacturers.
Semi-automated urine chemistry analyzers read reagent strips but require the operator to
measure and enter the color and clarity of the specimen.
They also require the operator to activate the instrument, manually dip and blot the reagent strip, and place the
strip on a platform in the strip reader.
The instrument moves the strip under a detector, reads the reflectance of each reaction pad at
the proper time, and displays the results for verification, printing, or electronic reporting.
Patient information is entered by the operator or obtained by a barcode reader integrated into the system.
Many include memory to store patient and quality control results, an integrated printer or printer interface, and
an interface for a laboratory information system.
Semi-automated urine chemistry analyzers
1) Urisys 1100 Urine Analyzer
2) Cobas u411 Urinalysis Test System
3) Accustrip URS Urinalysis Reader
In addition to urine reagent strips, it also reads immunoassay cartridges. It is a CLIA-
waived, small, portable, bench-top instrument powered by batteries.
The optical system consists of a series of six LEDs, each at a different wavelength, that illuminates the entire
strip or cassette length.
Reflected light from the strip passes through a lens focused on a charge-coupled device (CCD), which
converts the light intensity into an electronic signal for processing.
Results are reported to the operator via touch screen display, onboard printer, or computer interface.

2. Urisys 1100 urine analyzer - compact, bench-top, CLIA-waived, semi-automated reflectance photometer
designed to read Chemstrip10MD, Chemstrip 7, and Chemstrip 5 OB urine strips.
Each test pad is read photometrically in less than 70 seconds.
The Urisys 1100 has a throughput of up to 100 samples/hour.
It corrects the specific gravity in highly alkaline samples and compensates for urine color.
Data entry is through a barcode reader or keyboard, and there is an integrated printer and advanced data
connectivity for transmission of results.
Cobas u 411 urinalysis test system - bench-top, semi-automated, reflectance photometer for small and
medium-sized laboratories designed to read Chemstrip 10 UA reagent test strip.
The analyzer has a high throughput of up to 600 test strips/hour with continuous strip loading.
The optical unit contains 4 LEDs that emit light at wavelengths of 470nm, 555 nm, and 620 nm.
The reflected light is detected by 11 wide-range photosensors using automatic strip detection by two sensors.
The analyzer compensates for urine color.
Calibration verification is performed using a calibration strip included with the analyzer.
Sample identification is by manual entry, barcode reader, or download from the host computer.
There is an integrated thermal printer and serial interfaces to a barcode reader, LIS.
There is also a USB port – memory device / pendrive.
All of the semi-automated analyzers showed good user-friendliness and analytic performance,
with five of the six showing perfect agreement with the laboratory standard for the nitrite test. The sensitivity
for leukocytes and erythrocytes was lower than the automated findings, but the specificity was high.
Recent advance:-The most recent technological innovation in CLIA-waived urinalysis assays is the
smartphone-based dipstick reader.
Smartphones are widely used in medicine for communication and data storage and manipulation, but
urinalysis is one of the first diagnostic applications.
Fully automated urine chemistry analyzers
Part of an integrated system in a high-volume laboratory with urine sediment analysis. In
these instruments, multiple barcoded tubes of urine are loaded into a rack or carousel for sample identification
by barcode reading and automatic pipetting of a precisely measured urine aliquot directly onto a reagent strip.
The reagent strip is advanced to a reflectance photometer that measures the color change of each reaction pad
at the proper time and at the appropriate wavelength.
The instruments also use measurements of light transmission or light scatter to determine urine clarity
and refractive index to measure specific gravity.
Urine color is determined by multiple wavelength spectrophotometry or by reflectance photometry.
Abnormal results are flagged to identify specimens requiring microscopic sediment examination or
further testing.
An interface with the laboratory information system permits transmission of patient results and quality
control measurements for storage and further analysis.
The reagent strip is automatically disposed of when the analysis is complete.
Current models of fully automated urine chemistry analyzers include:
1) iChemVelocity
2) UC-3500 Fully Automated Urine Chemistry Analyser
3) Cobas u 601 urine analyzer
Since the refractive index and specific gravity of urine are measures of the amount of solute,
the refractive index of the specimen is measured by a fiber optic refractive sensor system and converted to a
quantitative specific gravity result.

3. iChemVELOCITY - fully automated urine chemistry analyzer that reads test strips with a dual wavelength
reflectance system.
The plastic strips contain nine pads impregnated with chemicals specific for the determination of individual
parameter.
Test strips are placed onto a strip conveyor system by a mechanical extractor.
A sample probe mixes the sample, aspirates an aliquot of urine and dispenses it onto each reagent pad.
At defined wavelengths it analyzes the color changes and the intensity of reflected light from the reaction
pads.
Specific gravity is determined with an electronic refractometer assembly.
Color is measured by transmitted light and clarity is measured by scattered light.
The instrument has a throughput of up to 210 samples per hour.
Cobas u 601 - modular analyzer - fully automated urine strip testing 240 samples/hour.
The instrument consists of a computer with touchscreen display, rack transport system, liquid handling
system, test strip cassette compartment, automated test strip processing area, test strip reflectance photometer,
and physical measurement cell (PMC) for clarity and specific gravity.
Patient identification - barcode reader.
Urine sample tubes are manually placed into a rack, which is loaded into the analyzer.
The rack is automatically moved within the analyzer fluid handling station using a rack conveyor.
The test strips are stored in a cassette that holds 400 test strips.
Each cassette is identified by a unique radiofrequency identification (RFID) tag that also contains information
on expiration date and lot number.
The instrument uses reagent strips with an iodate-impregnated mesh layer that provides resistance to ascorbic
acid and ensures uniform color development.
This technology helps to prevent false-negative results for glucose and hemoglobin and permits the detection
of low concentrations of glucose and erythrocytes/hemoglobin (5–10 erythrocytes/mL) in the presence of high
levels of ascorbic acid.
UC-3500 - modular, fully automated urine chemistry analyzer marketed by Sysmex Corporation.
It has a high throughput of 276 urine specimens/hour using a sample handler that can hold 8 tube racks with
10 tubes each.
The instrument is highly sensitive for albumin, with a low detection limit of 5.5 mg/L.
The instrument uses reflectance photometry with a color CMOS sensor.
CMOS sensor distinguishes RBCs and free hemoglobin.
The instrument automatically detects the position of the test strip pads, recognizing wrong strips and abnormal
urine color.
AUTOMATED MICROSCOPY ANALYZERS
Microscopic examination of urine sediment is a labor-intensive and time-consuming procedure subjected to
subjective interpretation and clerical errors.
Automated microscopic analysis of uncentrifuged urine provides many benefits:-
1) Decreased labor costs and
2) Improved laboratory productivity,
3) Improved turnaround time,
4) Reduced observer-associated error and bias,
5) Improved accuracy and precision,
6) Elimination of centrifugation,
7) Reduced operator exposure to biohazardous material,
8) Minimization of clerical errors, and

4. 9) Quality assurance, competency assessment, and education.
The Yellow IRIS urinalysis workstation - first commercial instrument to perform “automated intelligent
microscopy.” First urine analyzer to use flow imaging microscopy.
Flow Imaging Particle Analysis - capture magnified digital images of particles in a fluid during passage
through a flow cell.
The particles are quantitated, measured, and identified using image recognition software.
The IRIS iQ200 bench-top automated urine microscopy analyzer that provides a quantitative or qualitative
count of cells, casts, crystals, organisms, and other formed elements in a urine specimen as they are passed in
hydrodynamic flow in front of a digital camera.
The analyzer counts and auto-identifies the particles and stores the images for verification by the operator.
It consists of a microscopy module, computer workstation module, and optional load / unload stations.
A CCD video camera coupled to the microscope captures 500 frames per sample.
Cell counts can also be performed on body fluids other than urine, with the exception of cerebrospinal fluids
and other specimens with very low cell counts
Flow Cytometric Particle Analysis
In urine flow cytometers, aliquots of urine are stained with fluorescent dyes specific for DNA and cell
membrane components and then passed through a flow cell that orients the cells and other particles into single
file by hydrodynamic focusing.
The particle stream is illuminated by a laser beam, which excites fluorescent dyes attached to the particles and
scatters light.
The present instruments use two flow channels, one for bacteria and the other for cells and all other particles.
Sensors detect impedance, fluorescence, and scattered light at forward and side angles.
The data is then passed to a computer with specialized analytic software for analysis and display.
Eg:- UF-100 analyzer.
UF-1000i
INTEGRATED, FULLY AUTOMATED URINALYSIS SYSTEMS
Fully automated urinalysis systems that provide integrated analysis of urine chemistry and microscopy are
optimal for larger, high-volume laboratories.
In these systems, barcoded urine specimen tubes are loaded into the analyzer, patient identification and test
orders are obtained from the laboratory information system, chemical and/or microscopic analysis is
automatically performed, and the results are autoverified or held for further evaluation by the system operator.
Typically, chemical analysis is performed first, and the specimen is automatically transported to the
microscopy unit if indicated by user-defined criteria.
These systems optimize laboratory productivity and have a high throughput.
Eg:- iRICELL Automated Urinalysis System
CLINITEK AUWi System
LabUMat chemistry analyzer with a UriSed microscopy unit
AUTION HYBRID System