PERFORMANCE SUMMARY: DRI-CHEM and Element DC Veterinary Chemistry Analyzers DRI-CHEM Veterinary Chemistry Analyzer.

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PERFORMANCE SUMMARY: DRI-CHEM and Element DC Veterinary Chemistry Analyzers DRI-CHEM 7 Veterinary Chemistry Analyzer Element DC Veterinary Chemistry Analyzer DRI-CHEM 4 Veterinary Chemistry Analyzer Smarter, Together.

DRI-CHEM and Element DC Analyzers: Summary of Performance Reproducibility Simply Unsurpassed Solid reproducibility is the essential foundation required for analytical reliability. If a system has demonstrated reproducibility, is calibrated to a standard, and calibration is monitored by a quality control program, then the user can be assured of analytical reliability. This eliminates or reduces the need for individual facilities to replicate accuracy studies. Perspectives on reproducibility and use of quality control programs in veterinary in-hospital laboratories have recently been summarized. 1, 2 Reproducibility is easily tested by repeated analysis of the same sample. Below are tables of representative reproducibility of 2 sequential replicate analyses of serum with a number of abnormal values for the tests in the comprehensive profile plus electrolytes. The Minimum and Maximum values are the best gauge for interpretation of reproducibility. Concentration measurements typically have the best reproducibility. Enzyme activity measurements are inherently subject to greater variation in reproducibility. Kidney BUN Creatinine Phosphorus Mean 48. 5.1 7.3 Liver ALT ALP GGT T Bilirubin Mean 81 834 25 4. Min 46.8 4.9 7.1 Max 48.8 5.3 7.5 Min 76 728 198 3.9 Max 87 91 21 4. Metabolism/Electrolytes T Protein Albumin Glucose Cholesterol Calcium Na + K + Cl - Mean 3.4 4. 239 89 12.2 146 4.4 19 Min 3.3 3.8 233 85 11.9 144 4.4 17 Max 3.5 4.3 244 93 12.5 147 4.5 111 Summary Points: Excellent reproducibility. Note that concentration measurements are expected to be more precise than enzyme activity measurements. Good reproducibility is expected to be tighter than the tolerance limits of a QC program. Without excellent reproducibility, it is inherently impossible to achieve accuracy! References: Reproducibility and quality control information. 1. Weiser, MG, Vap, LM, Thrall, MA: Perspectives and Advances in In-Clinic Laboratory Diagnostic Capabilities: Hematology & Clinical Chemistry. In Veterinary Clinics of North America: Small Animal Practice. Issue title: Clinical Pathology and Diagnostic Techniques. Vol 37, (March 27), pp. 221-236. 2. Weiser, MG, Thrall, MA: Quality Control Recommendations and Procedures for In-Clinic Laboratories. In Veterinary Clinics of North America: Small Animal Practice. Issue title: Clinical Pathology and Diagnostic Techniques. Vol 37, (March 27), pp. 237-244. 1

Correlation Study Results Heska s chemistry analyzer technology has been tested in comparison with the most commonly established chemical procedures on an automated Hitachi system. This system and procedures are used by most professional veterinary laboratories and teaching hospitals. For purposes of this study, the DRI-CHEM 4 was utilized but the results can be applied to the DRI-CHEM 4, 7 and Element DC Analyzers because all of the systems use the same reagents and processing methods. Data presented here includes combined analysis of plasma and serum from dogs and cats for analytes having a range of available abnormal samples for testing. These show excellent correlation for a population of animals measured on two different technologies. BUN (mg/dl) r=1. 6 5 4 3 2 1 1 2 3 4 5 6 CREATININE (mg/dl) r=.98 2.5 2. 1.5 1..5...5 1. 1.5 2. 2.5 2

PHOSPHORUS (mg/dl) r=.97 7 6 5 4 3 2 1 1 2 3 4 5 6 7 ALT/GPT (U/L) r=1. 8 7 6 5 4 3 2 1 1 2 3 4 5 6 7 8 9 8 7 ALP (U/L) r=.99 6 5 4 3 2 1 1 2 3 4 5 6 7 8 9 3

15 GLUCOSE (mg/dl) r=.97 13 11 9 7 5 3 5 7 9 11 13 15 TOTAL CHOLESTEROL (mg/dl) r=1. 5 45 4 35 3 25 2 15 1 5 1 2 3 4 5 CALCIUM (mg/dl) r=.93 15 14 13 12 11 1 9 8 7 6 6 7 8 9 1 11 12 13 14 15 4

K + (meq/l) r=.93 7. 6.5 6. 5.5 5. 4.5 4. 3.5 3. 2.5 2. 2 3 4 5 6 7 TOTAL PROTEIN (g/dl) r=.95 11 1 9 8 7 6 5 4 3 3 5 7 9 11 ALBUMIN (g/dl) r=.83 5. 4.5 4. 3.5 3. 2.5 2. 1.5 1. 1. 1.5 2. 2.5 3. 3.5 4. 4.5 5. Summary Points: This is excellent correlation for a population of animals measured on two different technologies. There is a bias between the two methods for Albumin. Liquid chemistry methods overestimate animal Albumin concentrations. Dry chemistry Albumin methods yield results more consistent with serum protein electrophoresis. 5

For questions or further assistance please call Technical Support Services at 1-8-464-3752, option 3. 212 Heska Corporation. All Rights Reserved. DRI-CHEM is a registered trademark of FUJIFILM Corporation. is a trademark of Hitachi, Ltd. HESKA is a registered trademark and Element DC and Smarter, Together are trademarks of Heska Corporation in the U.S. and other countries. Order# 24264-1 112 43722-1