141229 UC1 CLINITEK Novus V1.1 US WP.2

2015-08-06

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Order No. A91DX-POC-141229-UC1-4A00
07-2015 | All rights reserved
© 2015 Siemens Healthcare Diagnostics Inc.
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www.siemens.com/diagnostics
www.usa.siemens.com/diagnostics Answers for life.
CLINITEK Novus Automated
Urine Chemistry Analyzer
A Performance Study
White Paper
CLINITEK Novus Automated Urine Chemistry Analyzer Performance Study CLINITEK Novus Automated Urine Chemistry Analyzer Performance Study
2 3
Introduction
The CLINITEK Novus® Urine Chemistry Analyzer from
Siemens Healthcare Diagnostics is a novel automated
urinalysis system that employs trusted urine chemistry
technology to deliver consistent, high-quality results.
We are reporting studies that were undertaken to assess
the correlation of CLINITEK Novus analyzer test results with
results obtained using CLINITEK Atlas® analyzer.
Summary
Results from all CLINITEK Novus analyzer tests validated
excellent correlation with results determined using
proven Siemens CLINITEK® urine chemistry systems
(Table 1).
CLINITEK Novus Automated
Urine Chemistry Analyzer
A Performance Study
Advancing Urinalysis Reliability and
Productivity with Trusted Technology
and Enhanced Software
The CLINITEK Novus Automated Urine Chemistry Analyzer
combines proven dry-pad urine chemistry technology
with an easy-to-use cassette test format to deliver reliable
test results and ensure maximum productivity in busy
laboratories. Offering a full spectrum of tests and a
throughput of up to 240 samples per hour, the CLINITEK
Novus analyzer streamlines workflow, simplifies routine
urinalysis and STAT testing, and delivers consistent, high-
quality results, even during peak periods.
Enhanced Software Improved
Bilirubin Test Results
CLINITEK Novus analyzer software employs a patent-
pending algorithm to decrease the number of false
positive bilirubin results. Utilizing digital camera-based
detection technology, this algorithm allows for the
detection of true bilirubin, as confirmed by Ictotest®
reflex testing.
A study was conducted to verify the improved accuracy
of bilirubin reporting. 270 samples were run on three
CLINITEK Novus analyzers and one CLINITEK Atlas analyzer
using one reagent lot. Results verified by Ictotest tablet
confirmation demonstrated that compared to the
CLINITEK Atlas analyzer, the CLINITEK Novus analyzer
Sample population obtained from external vendors and multiple clinical
laboratories in the USA and Japan. 15% of the population was contrived.
Individual laboratory performance will vary depending upon sample population
tested and may not match the results detailed above.
Table 1: CLINITEK Novus analyzer test results: Correlation with CLINITEK Atlas analyzer analyzer results.
CLINITEK
Novus Analyzer Test
Reference Siemens
Analyzer
Positive
Agreement
(Sensitivity)
Negative
Agreement
(Specificity)
Exact
Agreement
Within
One Level
Agreement
Blood CLINITEK Atlas Analyzer 100% 97% 92% 100%
Glucose CLINITEK Atlas Analyzer 100% 97% 92% 100%
Ketone CLINITEK Atlas Analyzer 80% 100% 83% 100%
Leukocyte CLINITEK Atlas Analyzer 98% 90% 86% 100%
Nitrite CLINITEK Atlas Analyzer 97% 100% 99% 100%
pH CLINITEK Atlas Analyzer NA NA 77% 99%
Urobilinogen CLINITEK Atlas Analyzer 100% 97% 88% 100%
reduced the bilirubin false-positive rate by 7%, provided
greater accuracy (fewer false positives with 0.4% false
negatives) in routine bilirubin urinalysis and served to
decrease the time and costs associated with potentially
unnecessary follow-up bilirubin testing.
Improved Color Correction Enhances
CLINITEK Novus Analyzer Performance
Improvement in the detection of highly-colored urine
specimens with the CLINITEK Novus analyzer enhances
test performance for bilirubin (see above), blood, ketone,
glucose, leukocyte, nitrite, and urobilinogen. The color
of the urine is measured and subtracted from the color of
the reacted reagent pad to compensate for non-specific
color changes of the pad. It should be noted that highly-
colored urine samples typically represent less than 5% of
all samples tested.
Highly Sensitive Detection of Red
Blood Cells in Specimens
The Non-Hemolyzed Trace (NHT) reporting range of the
CLINITEK Novus analyzer increases sensitivity of intact
red blood cell (RBC) detection in urine. This assists in
better matching what is seen during follow-up
sedimentation analysis. The CLINITEK Novus analyzer
can detect uneven/speckled samples: Interpretation
of the standard deviation of color measurement between
different areas of the test pad detects very low levels of
non-hemolyzed cells in a sample.
CLINITEK Novus Automated Urine Chemistry Analyzer Performance Study CLINITEK Novus Automated Urine Chemistry Analyzer Performance Study
4 5
Software Improves Workflow and
System Productivity
CLINITEK Novus analyzer software enhancements
add functionality in terms of QC, reporting, and
operator friendliness:
• Easier-to-use help screens and navigation maps
Enhanced results QC with convenient Levey-
Jennings Charts
• Smart control graphs and checks:
Review and print QC results graphs, customizable
by date range, control log, cassette, or operator ID
– Configure QC reporting limits for controls
– Identify failed control results
• Flexible analyzer operation with multiple barcode types:
Read Codabar, Code 128, Code 39, Code 93, and
single barcode symbologies
Unique Load-and-Go Cassette Tests
• Each CLINITEK Novus cassette holds 450 test sets
Easy-to-use cassettes simplify analyzer operation,
maintenance, and cleaning
Proven test pads ensure quality results with excellent
sensitivity and specificity
Cassettes eliminate the need to align traditional
urinalysis test strips
Customizable Test Menus
CLINITEK Novus analyzer cassette types offer testing
chemistries configured for the needs of differing
patient populations:
CLINITEK Novus 10 cassettes for routine urinalysis,
including: Glucose, Leukocyte, Nitrite, Bilirubin, Ketone,
Blood, pH, Urobilinogen, and Protein
Specific gravity, color, and clarity are also analyzed.
Proven Performance in Urinalysis
from the Physician’s Office to the
Central Lab
CLINITEK urine chemistry analyzers from Siemens
employ the same proven chemistry formulations,
regardless of the test format. They deliver consistent
results in every setting, from the physician’s office
to the high-volume automated laboratory.
The CLINITEK brand remains recognized the world over
as a leader in reliable urine chemistry testingmeeting
the needs of different testing volumes, enhancing
productivity, and providing broad clinical insights
into patient health.
Materials and Methods
(Excluding Bilirubin)
A total of 310 clinical and contrived samples were
tested in this study. An additional 30 clinical samples
were tested during urobilinogen evaluation. Clinical
samples were obtained from Discovery Life Sciences, Inc.,
and the University of Louisville. Contrived samples were
made by adding known levels of each analyte to negative
urine samples.
One replicate of each sample was tested on three
CLINITEK Novus analyzers, two CLINITEK Atlas analyzers.
Results for each analyte were summarized in frequency
tables with Positive Agreement (Sensitivity), Negative
Agreement (Specificity), and Percent Exact and Within
One Block Agreement calculated for each analyte.
Materials and Methods (Bilirubin)
A separate study was undertaken to validate CLINITEK
Novus analyzer bilirubin performance equivalency with the
CLINITEK Atlas analyzer. A total of 270 samples were
tested.
Clinical samples were obtained from Discovery Life
Sciences, Inc., the University of Louisville, and Siemens
Healthcare Diagnostics K.K. (Tokyo, Japan). Additional
negative urine specimens were collected from Siemens
employees and used to contrive a larger number of
bilirubin-positive samples (15% of the sample population).
One replicate of each sample was tested on three
CLINITEK Novus analyzers and one CLINITEK Atlas analyzer.
Ictotest reflex testing was employed to identify discrepant
(false-positive) results. All discrepant results (Ictotest-
negative, 35 results) were removed from the comparison
between CLINITEK Novus and Atlas analyzers in order
to measure true concordance. Results were compiled
in frequency tables, and Positive Agreement (Sensitivity),
Negative Agreement (Specificity), and Percent Exact
and Within One Block Agreement calculated.
Results
The results for CLINITEK Novus analyzer performance
compared to CLINITEK Atlas analyzer is listed in the
frequency tables (following pages), with calculated
rates of agreement and clinical performance.
Figure 1: CLINITEK Novus analyzer QC graphing
with Levey-Jennings charts.
Figure 2: CLINITEK Novus analyzer barcode
symbology options.
CLINITEK Novus Automated Urine Chemistry Analyzer Performance Study CLINITEK Novus Automated Urine Chemistry Analyzer Performance Study
6 7
Blood CLINITEK Atlas
Analyzer Negative Trace Small Moderate Large Total
CLINITEK Novus
Analyzer
Negative 634 ––––634
Trace 19 52 4––75
Non-Hemolyzed
Trace (NHT) 1––––1
Small 16 46 17 79
Moderate 1 10 87 2100
Large –––137 38
Total 654 69 60 105 39 927
Positive Agreement (Sensitivity): 100%
Negative Agreement (Specificity): 97%
Exact Agreement: 92%
Within One Level Agreement: 100%
Blood
Frequency table for CLINITEK Novus analyzer blood performance compared to CLINITEK Atlas analyzer:
Within One Level (all) and Exact Agreement (appearing in boldface).
Glucose CLINITEK Atlas
Analyzer Negative 100 mg/dL 250 mg/dL 500 mg/dL ≥ 1,000
mg/dL Total
CLINITEK Novus
Analyzer
Negative 594 –––594
100 mg/dL 21 63 84
250 mg/dL 35 97 132
500 mg/dL 1 8 58 370
≥ 1,000 mg/dL 245 47
Total 615 99 105 60 48 927
Positive Agreement (Sensitivity): 100%
Negative Agreement (Specificity): 97%
Exact Agreement: 92%
Within One Level Agreement: 100%
Glucose
Frequency table for CLINITEK Novus analyzer glucose performance compared to CLINITEK Atlas analyzer:
Within One Level (all) and Exact Agreement (appearing in boldface).
Ketone CLINITEK Atlas
Analyzer Negative Trace 15 mg/dL 40 mg/dL 80 mg/dL ≥ 160 mg/dL Total
CLINITEK Novus
Analyzer
Negative 457 93 3 – – – 553
Trace 269 4 – – – 75
15 mg/dL 111 2 113
40 mg/dL ––240 42
80 mg/dL ––––32 17 49
≥ 160 mg/dL ––––31 64 95
Total 459 162 120 42 63 81 927
Positive Agreement (Sensitivity): 80%
Negative Agreement (Specificity): 100%
Exact Agreement: 83%
Within One Level Agreement: 100%
Ketone
Frequency table for CLINITEK Novus analyzer ketone performance compared to CLINITEK Atlas analyzer:
Within One Level (all) and Exact Agreement (appearing in boldface).
Leukocyte CLINITEK Atlas
Analyzer Negative Trace Small Moderate Large Total
CLINITEK Novus
Analyzer
Negative 545 8–––553
Trace 61 78 21 160
Small 741 18 66
Moderate – – 439 952
Large – – 393 96
Total 606 93 66 60 102 927
Positive Agreement (Sensitivity): 98%
Negative Agreement (Specificity): 90%
Exact Agreement: 86%
Within One Level Agreement: 100%
Leukocyte
Frequency table for CLINITEK Novus analyzer leukocyte performance compared to CLINITEK Atlas analyzer:
Within One Level (all) and Exact Agreement (appearing in boldface).
CLINITEK Novus Automated Urine Chemistry Analyzer Performance Study CLINITEK Novus Automated Urine Chemistry Analyzer Performance Study
8 9
Nitrite CLINITEK Atlas
Analyzer Negative Positive Total
CLINITEK Novus
Analyzer
Negative 560 12 572
Positive 1354 355
Total 561 366 927
Positive Agreement (Sensitivity): 97%
Negative Agreement (Specificity): 100%
Exact Agreement: 99%
Within One Level Agreement: 100%
Nitrite
Frequency table for CLINITEK Novus analyzer nitrite performance
compared to CLINITEK Atlas analyzer: Within One Level (all) and Exact
Agreement (appearing in boldface).
pH CLINITEK Atlas
Analyzer 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 Total
CLINITEK Novus
Analyzer
5.0 182 3––––––185
5.5 28 110 4–––––142
6.0 25 125 –––––150
6.5 47 50 ––––97
7.0 ––113 36 –––50
7.5 ––––33 38 3 74
8.0 –––––41 11 52
8.5 –––––29314
≥ 9.0 ––––––1159 160
Total 213 138 177 63 69 81 24 162 927
Exact Agreement: 77%
Within One Level Agreement: 99%
pH
Frequency table for CLINITEK Novus analyzer ketone performance compared to CLINITEK Atlas analyzer:
Within One Level (all) and Exact Agreement (appearing in boldface).
Urobilinogen CLINITEK Atlas
Analyzer 0.2 EU/dL 1.0 EU/dL 2.0 EU/dL 4.0 EU/dL ≥ 8.0 EU/dL Total
CLINITEK Novus
Analyzer
0.2 EU/dL 641 50 –––691
1.0 EU/dL 462 –––66
2.0 EU/dL 26 83 14 123
4.0 EU/dL 19 81 3103
≥ 8.0 EU/dL –––430 34
Total 645 138 102 99 33 1,017
Positive Agreement (Sensitivity): 100%
Negative Agreement (Specificity): 97%
Exact Agreement: 88%
Within One Level Agreement: 100%
Urobilinogen
Frequency table for CLINITEK Novus analyzer urobilinogen performance compared to CLINITEK Atlas
analyzer: Within One Level (all) and Exact Agreement (appearing in boldface).
CLINITEK Novus Automated Urine Chemistry Analyzer Performance Study CLINITEK Novus Automated Urine Chemistry Analyzer Performance Study
10 11
Discussion and Conclusions
CLINITEK Novus analyzer software test results were found
to correlate well with:
CLINITEK Atlas analyzer results for blood, glucose, ketone,
leukocyte, nitrite, pH, and urobilinogen
The CLINITEK Novus analyzer software demonstrably
improves test results quality. Bilirubin false positive results
verses the CLINITEK Atlas analyzer were shown to be
reduced by 7%, with 0.4% false negatives, using the new
algorithm, and the ability to differentiate NHT from
hemoglobin, results are a better clinical indicator of the
abnormal presence of red blood cells in urine. Similarly,
the improved color correction algorithm employed by the
CLINITEK Novus analyzer reduces false-positive ketone
results associated with highly-colored specimens: 93 trace
results on the CLINITEK Atlas analyzer were reported as
negative on the CLINITEK Novus analyzer.
The greater accuracy of bilirubin reporting with CLINITEK
Novus software allows for fewer false positives, decreasing
the labor, time, and costs associated with potentially
unnecessary reference reflex testing.
The CLINITEK Novus analyzer was shown to generate
results consistent with those obtained using proven
Siemens reference analyzers. Taken together with the
enhanced productivity, ease of use, extended functionality,
and quality checks that the instrument supports, operators
can be confident that the CLINITEK Novus analyzer can be
used for reliable, high-quality urinalysis testing.
Note:
This White Paper is based on results from an internal study conducted
at the Siemens Healthcare Diagnostics facility in Elkhart, Indiana, U.S.
This study was conducted using Version 1.1 of the CLINITEK Novus
software.

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