Measurement in Iran. Performance, Challenges, and. Rasad Pathobiology and Genetic Laboratory

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1 Methods of Creatinine Measurement in Iran Performance, Challenges, and Improvement tstrategiest R Mohammadi Ph D R. Mohammadi, Ph.D Rasad Pathobiology and Genetic Laboratory

2 Performance

3 Methods of Creatinine Measurments Method Evaluation Laboratory Performance

4 METHOD EVALUATION Pars Azmon Kit Pishtaz Teb Kit Audit Kit Man Kit Bionik Kit

5 METHOD EVALUATION Precision Study Within run imprecision Comparison Study Paired t test, Linear Regression Analysis, Deming Regression Analysis, Clinical i l Comparison Detection Study LoB, LoD, FS, and LoQ Linearity Study

6 TOTAL ALLOWABLE ERROR (TEa) Clinical LaboratoryImprovement Amendments (CLIA) Recommends TEa of 15% for Creatinine Measurement National Kidney Disease Education Program (NKDEP) Recommends TEaof 7.6% for Creatinine Measurement

7 PRECISION STUDY Within runimprecisionat NormalConcentration Parameter Pars Azmon Pishtaz Teb Audit Man Bionik n Mean (mg/dl) SD (mg/dl) CV (%) Acceptable limits were calculated according to one forth of TEa%

8 PRECISION STUDY Within runimprecisionat High Concentration Parameter Pars Azmon Pishtaz Teb Audit Man Bionik n Mean (mg/dl) SD (mg/dl) CV (%) Acceptable limits were calculated according to one forth of TEa%

9 COMPARISON STUDY During February and Marchof 2016, creatinine concentration of 97 patient s serum samples and 100 patient s urine (1/50 diluted) samples were measured by five commonly used kits in Iran, including Pars Azmon, Pishtaz Teb, Audit, Man, and Bionik. Results of each kit compared with total mean results by using paired t test, linear regression, and Deming regression. Clinically acceptable limits were calculated according to one third of TEa%

10 COMPARISION STUDY: Urine Samples Range and Mean Kit Range (mg/dl) Mean (mg/dl) Pars Azmon 0.54 to Pishtaz Teb 0.56 to Audit 0.52 to Man 0.51 to Bionik 0.20 to Total* 0.53 to * Total Results calculated from all kit results, except Bionik results

11 COMPARISION STUDY: Urine Samples MeanDifference Analysis Kit Pars Azmon Paired t test test (p<0.0001) Cllinically (One third of TEa%) TEa 15% (1.88 to 2.08) Insignificant TEa 7.6% (1.93 to 2.03) Insignificant Pishtaz ih Teb ifi ifi ifi (p<0.0001) Audit Man Bionik (p<0.0001) 0001) (p<0.0001) (p<0.0001) Insignificant Insignificant Insignificant

12 COMPARISION STUDY: Pars Azmon y = * x r = , Pars sx Total

13 COMPARISION STUDY: Pishtaz Teb y = * x r = , Pish hx Total

14 COMPARISION STUDY: Audit y = * x r = , Aud dx Total

15 COMPARISION STUDY: Man y = * x r = , Man nnx Total

16 COMPARISION STUDY: Bionik y = * x r = X Bio Total

17 COMPARISION STUDY: Serum Samples Range and Mean Kit Range (mg/dl) Mean (mg/dl) Pars Azmon 0.46 to Pishtaz Teb 0.73 to Audit 0.89 to Man 0.69 to Bionik 1.07 to Total 0.85 to

18 COPARISION STUDY: Serum Samples MeanDifference Analysis Kit Pars Azmon Paired t test test (p<0.0001) Cllinically (One third of TEa%) TEa 15% (1.32 to 1.46) TEa 7.6% (1.35 to 1.43) Pishtaz ih Teb ifi ifi ifi (p<0.0001) Audit Man Bionik (p<0.0001) 0001) (p<0.0001) (p<0.0001)

19 COPARISION STUDY: Pars Azmon y = * * x r = , Pars Total

20 COPARISION STUDY: Pishtaz Teb y = * * x r = , Pish Total

21 COPARISION STUDY: Audit y = * x r = , it Aud Total

22 COPARISION STUDY: Man y = * * x r = , Ma an Total

23 COPARISION STUDY: Bionik y = * * x r = ik Bion Total

24 COPARISION STUDY: Bionik y = x (Deming Regression) 6 M ean of Bionik k1 and Bionik Total

25 DETECTION STUDY

26 DETECTION STUDY Parameter Pars Azmon Pishtaz Teb Audit Man Bionik LoB LoD FS LoQ

27 LINEARITY STUDY

28 LINEARITY STUDY Pars Azmon (Claimed: 0.2 to 8.0 mg/dl) No Observed Value (mg/l) Target Value (mg/l) Deviation (%) Interpretation Nonacceptable Nonacceptable Nonacceptable Nonacceptable

29 LINEARITY STUDY Pishtaz Teb (Claimed: 0.1 to mg/dl) No Observed Value (mg/l) Target Value (mg/l) Deviation (%) Interpretation Acceptable Acceptable Nonacceptable Nonacceptable Nonacceptable

30 LINEARITY STUDY Audit (Up to 31 mg/dl) No Observed Value (mg/l) Target Value (mg/l) Deviation (%) Interpretation Acceptable Acceptable Acceptable Acceptable

31 LINEARITY STUDY Man (Claimed: 0.3 to 15.0 mg/dl) No Observed Value (mg/l) Target Value (mg/l) Deviation (%) Interpretation Acceptable Nonacceptable Nonacceptable Nonacceptable

32 LINEARITY STUDY Bionik (Claimed: to 8.0 mg/dl) No Observed Value (mg/l) Target Value (mg/l) Deviation (%) Interpretation Acceptable Acceptable Acceptable Acceptable Acceptable

33 LABORATORY PERFORMANCE: EQAP 19 Results Acceptable (TEa = 17.8%) Acceptable (TEa = 7.6%) Kits No Range Mean Range N % Range N % Pars Pishtaz Audit Man Bionik Total

34 LABORATORY PERFORMANCE: EQAP 20 Results Acceptable (TEa = 17.8%) Acceptable (TEa = 7.6%) Kits No Range Mean Range N % Range N % Pars to Pishtaz to Audit to Man to Bionik to Total

35 LABORATORY PERFORMANCE: EQAP 21 Results Acceptable (TEa = 17.8%) Acceptable (TEa = 7.6%) Kits No Range Mean Range N % Range N % Pars to Pishtaz to Audit to Man to Bionik to Total

36 Challenges Biological Variation Specimen CV W % W CV B % B Index of Individuality Serum Urine, Concentration, Random Urine, Concentration, FistMorning Urine, Concentration, 24h Urine, Output, 24h

37 Challenges Methodology Imprecision, Calibration, Traceability, Bias, Linearity, Detection Limits Laboratory Errors Pre analytical, Analytical, Postanalytical

38 Improvement Strategies Method Standardization Method Selection Method Verification/Validation Method Performance Monitoring Standardization of Result Reporting Education and Training of Staffs Result Interpretation

39 Thank You

COMPARISON STUDY BETWEEN THE STATSPIN EXPRESS 4 HORIZONTAL CENTRIFUGE AND THE HERAEUS LABOFUGE 400 CENTRIFUGE WITH BD TUBES

Iris Sample Processing Toll-Free (8) 782-8774 6 Glacier Drive Phone (781) 551-1 Westwood, MA 29 Fax (781) 551-36 www.proiris.com info@proiris.com COMPARISON STUDY BETWEEN THE STATSPIN EXPRESS 4 HORIZONTAL