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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

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IntroductionThe 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.

SummaryResults 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 SoftwareThe 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 ResultsCLINITEK 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 PerformanceImprovement 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 SpecimensThe 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

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Software Improves Workflow and System ProductivityCLINITEK 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 MenusCLINITEK 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 LabCLINITEK 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 testing—meeting 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.

ResultsThe 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

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BloodCLINITEK Atlas

AnalyzerNegative 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 2 100

Large – – – 1 37 38

Total 654 69 60 105 39 927

Positive Agreement (Sensitivity): 100%Negative Agreement (Specificity): 97%Exact Agreement: 92%Within One Level Agreement: 100%

BloodFrequency table for CLINITEK Novus analyzer blood performance compared to CLINITEK Atlas analyzer: Within One Level (all) and Exact Agreement (appearing in boldface).

GlucoseCLINITEK Atlas

AnalyzerNegative 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 3 70

≥ 1,000 mg/dL – – – 2 45 47

Total 615 99 105 60 48 927

Positive Agreement (Sensitivity): 100%Negative Agreement (Specificity): 97%Exact Agreement: 92%Within One Level Agreement: 100%

GlucoseFrequency table for CLINITEK Novus analyzer glucose performance compared to CLINITEK Atlas analyzer: Within One Level (all) and Exact Agreement (appearing in boldface).

KetoneCLINITEK Atlas

AnalyzerNegative Trace 15 mg/dL 40 mg/dL 80 mg/dL ≥ 160 mg/dL Total

CLINITEK Novus Analyzer

Negative 457 93 3 – – – 553

Trace 2 69 4 – – – 75

15 mg/dL – – 111 2 – – 113

40 mg/dL – – 2 40 – – 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%

KetoneFrequency table for CLINITEK Novus analyzer ketone performance compared to CLINITEK Atlas analyzer: Within One Level (all) and Exact Agreement (appearing in boldface).

LeukocyteCLINITEK Atlas

AnalyzerNegative Trace Small Moderate Large Total

CLINITEK Novus Analyzer

Negative 545 8 – – – 553

Trace 61 78 21 – – 160

Small – 7 41 18 – 66

Moderate – – 4 39 9 52

Large – – – 3 93 96

Total 606 93 66 60 102 927

Positive Agreement (Sensitivity): 98%Negative Agreement (Specificity): 90%Exact Agreement: 86%Within One Level Agreement: 100%

LeukocyteFrequency 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

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NitriteCLINITEK Atlas

AnalyzerNegative Positive Total

CLINITEK Novus Analyzer

Negative 560 12 572

Positive 1 354 355

Total 561 366 927

Positive Agreement (Sensitivity): 97%Negative Agreement (Specificity): 100%Exact Agreement: 99%Within One Level Agreement: 100%

NitriteFrequency table for CLINITEK Novus analyzer nitrite performance compared to CLINITEK Atlas analyzer: Within One Level (all) and Exact Agreement (appearing in boldface).

pHCLINITEK Atlas

Analyzer5.0 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 – – 1 13 36 – – – 50

7.5 – – – – 33 38 3 – 74

8.0 – – – – – 41 11 – 52

8.5 – – – – – 2 9 3 14

≥ 9.0 – – – – – – 1 159 160

Total 213 138 177 63 69 81 24 162 927

Exact Agreement: 77%Within One Level Agreement: 99%

pHFrequency table for CLINITEK Novus analyzer ketone performance compared to CLINITEK Atlas analyzer: Within One Level (all) and Exact Agreement (appearing in boldface).

UrobilinogenCLINITEK Atlas

Analyzer0.2 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 4 62 – – – 66

2.0 EU/dL – 26 83 14 – 123

4.0 EU/dL – – 19 81 3 103

≥ 8.0 EU/dL – – – 4 30 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%

UrobilinogenFrequency table for CLINITEK Novus analyzer urobilinogen performance compared to CLINITEK Atlas analyzer: Within One Level (all) and Exact Agreement (appearing in boldface).

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Discussion and ConclusionsCLINITEK 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.