CLINITEK, Atlas, Novus, Status+, and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc. or its affiliates. All other trademarks are properties of their respective owners. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability. Order No. A91DX-POC-141229-UC1-4A00 07-2015 All rights reserved 2015 Siemens Healthcare Diagnostics Inc. White Paper Global Siemens Headquarters Siemens AG, Healthcare Wittelsbacherplatz 2 80333 Muenchen Germany Global Siemens Healthcare Headquarters Siemens AG, Healthcare Henkestrasse 127 91052 Erlangen Germany Telephone: +49 9131 84-0 www.siemens.com/healthcare Global Division Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591-5005 USA www.siemens.com/diagnostics Automated Urine Chemistry A Performance Study www.usa.siemens.com/diagnostics Answers for life.
Automated Urine Chemistry Performance Study Automated Urine Chemistry Performance Study Automated Urine Chemistry A Performance Study Introduction The Urine Chemistry 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 analyzer test results with results obtained using analyzer. Summary Results from all analyzer tests validated excellent correlation with results determined using proven Siemens CLINITEK urine chemistry systems (Table 1). Table 1: analyzer test results: Correlation with analyzer analyzer results. CLINITEK Novus Test Reference Siemens Positive (Sensitivity) Negative (Specificity) Exact Within One Level Blood 100% 97% 92% 100% Glucose 100% 97% 92% 100% Ketone 80% 100% 83% 100% Leukocyte 98% 90% 86% 100% Nitrite 97% 100% 99% 100% ph NA NA 77% 99% Urobilinogen 100% 97% 88% 100% Advancing Urinalysis Reliability and Productivity with Trusted Technology and Enhanced Software The Automated Urine Chemistry 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, highquality results, even during peak periods. Enhanced Software Improved Bilirubin Test Results analyzer software employs a patentpending 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 analyzers and one analyzer using one reagent lot. Results verified by Ictotest tablet confirmation demonstrated that compared to the analyzer, the 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. 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 Performance Improvement in the detection of highly-colored urine specimens with the 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 highlycolored 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 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 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. 2 3
Automated Urine Chemistry Performance Study Automated Urine Chemistry Performance Study Figure 1: analyzer QC graphing with Levey-Jennings charts. Software Improves Workflow and System Productivity 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 Figure 2: analyzer barcode symbology options. Unique Load-and-Go Cassette Tests Each 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 analyzer cassette types offer testing chemistries configured for the needs of differing patient populations: 10 cassettes for routine urinalysis, including: Glucose, Leukocyte, Nitrite, Bilirubin, Ketone, Blood, ph, Urobilinogen, and Protein 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 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 analyzers, two analyzers. Results for each analyte were summarized in frequency tables with Positive (Sensitivity), Negative (Specificity), and Percent Exact and Within One Block calculated for each analyte. Materials and Methods (Bilirubin) A separate study was undertaken to validate CLINITEK Novus analyzer bilirubin performance equivalency with the 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 analyzers and one analyzer. Ictotest reflex testing was employed to identify discrepant (false-positive) results. All discrepant results (Ictotestnegative, 35 results) were removed from the comparison between and Atlas analyzers in order to measure true concordance. Results were compiled in frequency tables, and Positive (Sensitivity), Negative (Specificity), and Percent Exact and Within One Block calculated. Results The results for analyzer performance compared to analyzer is listed in the frequency tables (following pages), with calculated rates of agreement and clinical performance. Specific gravity, color, and clarity are also analyzed. 4 5
Automated Urine Chemistry Performance Study Automated Urine Chemistry Performance Study Blood Frequency table for analyzer blood performance compared to analyzer: Ketone Frequency table for analyzer ketone performance compared to analyzer: Blood Negative Trace Small Moderate Large Total 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 (Sensitivity): 100% Negative (Specificity): 97% Exact : 92% Ketone Negative Trace 15 mg/dl 40 mg/dl 80 mg/dl 160 mg/dl Total 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 (Sensitivity): 80% Negative (Specificity): 100% Exact : 83% Glucose Frequency table for analyzer glucose performance compared to analyzer: Leukocyte Frequency table for analyzer leukocyte performance compared to analyzer: Glucose Negative 100 mg/dl 250 mg/dl 500 mg/dl 1,000 mg/dl 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 (Sensitivity): 100% Negative (Specificity): 97% Exact : 92% Total Leukocyte Negative Trace Small Moderate Large Total 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 (Sensitivity): 98% Negative (Specificity): 90% Exact : 86% 6 7
Automated Urine Chemistry Performance Study Automated Urine Chemistry Performance Study Nitrite Frequency table for analyzer nitrite performance compared to analyzer: Within One Level (all) and Exact (appearing in boldface). Nitrite Negative Positive Total Negative 560 12 572 Positive 1 354 355 Total 561 366 927 Positive (Sensitivity): 97% Negative (Specificity): 100% Exact : 99% Urobilinogen Frequency table for analyzer urobilinogen performance compared to analyzer: Urobilinogen 0.2 EU/dL 1.0 EU/dL 2.0 EU/dL 4.0 EU/dL 8.0 EU/dL Total 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 (Sensitivity): 100% Negative (Specificity): 97% Exact : 88% ph Frequency table for analyzer ketone performance compared to analyzer: ph 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 Total 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 : 77% Within One Level : 99% 8 9
Automated Urine Chemistry Performance Study Automated Urine Chemistry Performance Study Discussion and Conclusions analyzer software test results were found to correlate well with: analyzer results for blood, glucose, ketone, leukocyte, nitrite, ph, and urobilinogen The analyzer software demonstrably improves test results quality. Bilirubin false positive results verses the 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 analyzer reduces false-positive ketone results associated with highly-colored specimens: 93 trace results on the analyzer were reported as negative on the 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 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 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 software. 10 11