The Impact of Whole Blood Creatinine Testing Accuracy on Screening for Medical Imaging

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1 The Impact of Whole Blood Creatinine Testing Accuracy on Screening for Medical Imaging Presenter: Brad S. Karon MD, PhD We will begin shortly. If you need assistance with audio, call

2 The Impact of Whole Blood Creatinine Testing Accuracy on Screening for Medical Imaging Brad S. Karon MD PhD Director, Point of Care Testing Mayo Clinic Rochester, MN

3 Identify benefits and limitations of estimated glomerular filtration rate (egfr) as a screening tool for chronic kidney disease (CKD) Compare recommendations regarding the use of egfr for CKD screening and prevention of contrast-induced nephropathy Assess the reliability of whole blood creatinine methods in differentiating risk for contrastinduced nephropathy Clarify how egfr concordance impacts the effeciency and expense of imaging services

4 Kidney function - Renal physiology - CKD as public health problem - Creatinine and egfr measurement Contrast-induced nephropathy (CIN) - Definition of problem - Radiology/cardiology recommendations Data on whole blood creatinine for CIN Conclusions

5 Filter blood Remove toxins/drugs Maintain water balance Acid-base balance Electrolyte balance Filter unit = nephron urine

6 Renal function = ability to filter blood % decrease in filtering capacity before problem % decrease in filtering need for dialysis

7 Measuring renal function - (micro) albuminuria/proteinuria - Measure glomerular filtration rate (GFR) Blood filtered per unit time Find inert substance (creatinine, iothalamate, Iohexal, Inulin) Measure concentration in blood and urine Calculate GFR - Estimate glomerular filtration rate (GFR) Based on serum creatinine alone Based on egfr calculated from serum creatinine

8 What causes kidney disease? - Diabetes - High blood pressure - Glomerular disease (autoimmune, infectious) - Inherited and congenital kidney disease - Poisons, trauma, medications Types of kidney disease - Acute kidney disease - Chronic kidney disease - End stage renal disease

9 Chronic kidney disease (CKD) - Affects 19 million people in US - Associated with diabetes and hypertension - Loss of renal function over years - Early detection can delay progression to ESRD Control blood pressure Dietary modification Control blood glucose

10 Serum creatinine measurement - Serum creatinine goes up with renal failure Pros Commonly measured analyte Cons Blood levels rise when 50% function lost Other factors (muscle mass, age, gender, race, illness, diet) affect serum creatinine

11 Bottom Line: Difficulty identifying CKD with serum creatinine alone Estimated glomerular filtration rate (egfr) - Formula relating serum creatinine to measured GFR - Different formulas developed and tested over time

12 Goal is facile approach to recognizing CKD - Public health effort (access, commutable, cost)

13 Goal is facile approach to recognizing CKD - Public health effort (access, commutable, cost) Many different creatinine assays exist - Standardization good but not great

14 Goal is facile approach to recognizing CKD - Public health effort (access, commutable, cost) Many different creatinine assays exist - Standardization good but not great Several different formulas for egfr exist

15 Goal is facile approach to recognizing CKD - Public health effort (access, commutable, cost) Many different creatinine assays exist - Standardization good but not great Several different formulas for egfr exist Different creatinine values x different formulas = chaos

16 Goal is facile approach to recognizing CKD - Public health effort (access, commutable, cost) Many different creatinine assays exist - Standardization good but not great Several different formulas for egfr exist Different creatinine values x different formulas = chaos Need for standardized approach for egfr

17 K/DOQI guidelines - Kidney Disease Outcomes Quality Initiative - National Kidney Foundation - CKD = kidney damage or decreased GFR for 3 or more months - Clinical laboratories should report an egfr using a prediction equation, in addition to serum creatinine - Physicians should estimate GFR from prediction equations using serum creatinine and all or some of the following: age, sex, race and body size

18 Guidelines for egfr Stages of CKD: Normal GFR = in young adults Decreases with age Stage 1 2 Description Kidney damage with normal or GFR Kidney damage with mild GFR GFR (ml/min/1.73m2) Moderate GFR Severe GFR Kidney failure <15 (or dialysis) K/DOQI Clinical Practice Guidelines on Chronic Kidney Disease

19 Laboratory guidelines in flux Most labs report > 60 ml/min/1.73 m 2 as equations not accurate at higher GFR Some labs report only on some populations (less than 70 years, outpatients, adults > 18 yrs) In general egfr < 60 ml/min/1.73 m 2 will be viewed as abnormal

20 1. Report no egfr values 2. Report egfr on outpatients only 3. Report egfr on patients only 4. Report egfr on all patients 5. Report egfr on some other selected patient group 20% 20% 20% 20% 20% Report no egfr... Report egfr on... Report egfr on... Report egfr on... Report egfr on...

21

22 Contrast-induced nephropathy (CIN) - Radiographic contrast media used for CT and angiography can be toxic to kidney - CIN = increase in baseline creatinine within 48 hr of contrast (25%, mg/dl) - 3 rd leading cause of hospital-acquired renal failure

23 Patients at risk of CIN - CKD - Diabetes - Shock/hypotension (volume depletion) - Advanced age (> 75 yo) - Advanced congestive heart failure

24 Recognizing risk can prevent CIN - Hydration - Change contrast agents - Reduce contrast dose or volume - Sodium bicarbonate?

25 Recognizing risk can prevent CIN - Hydration - Change contrast agents - Reduce contrast dose or volume - Sodium bicarbonate? Focus on recognizing CKD before contrast

26 Recommendations for CIN prevention - Society for Cardiovascular Angiography and Interventions - Routine use of egfr recommended to identify patients at risk of CIN (MDRD) - egfr > 60 ml/min/1.73 m 2 low risk - egfr < 60 ml/min/1.73 m 2 high risk Consider one of several risk reduction strategies

27 Recommendations for CIN prevention - Canadian Association of Radiologists - egfr > 60 ml/min/1.73 m 2 very low risk - egfr ml/min/1.73 m 2 low to moderate risk - egfr < 30 ml/min/1.73 m 2 high risk - Screen at-risk patients with creatinine/egfr

28 Age > 75 higher risk for CIN egfr in patients > 70 not well established - Radiology guidelines use egfr for all patients - Some prediction equations not that good in older patients around cut-off of 60 ml/min/1.73 m 2

29 Use of whole blood (POC) creatinine - Real-time CIN screening of great benefit - Even lab creatinine performance of concern, don t report egfr over 60 - Whole blood creatinine methods greater imprecision, more interferences - How accurate are whole blood methods in discriminating egfr < 60 ml/min/1.73 m 2?

30

31 Goal: whole blood creatinine for rapid decision-making re: contrast

32 Goal: whole blood creatinine for rapid decision-making re: contrast Based on egfr and/or creatinine

33 Goal: whole blood creatinine for rapid decision-making re: contrast Based on egfr and/or creatinine Acceptance criteria for use: - 90% concordance on egfr - 95% creatinine results within 0.2 mg/dl of lab

34 Goal: whole blood creatinine for rapid decision-making re: contrast Based on egfr and/or creatinine Acceptance criteria for use: - 90% concordance on egfr - 95% creatinine results within 0.2 mg/dl of lab Design study to determine whether any available whole blood creatinine methods were acceptable

35 Study design 266 patients presenting for CT, stat creatinine if no value in last 30 d and: - Age > 70 - Hx renal disease/ckd/renal transplant - Diabetes - Pending creatinine value in lab

36 Study design 266 patients presenting for CT, stat creatinine if no value in last 30 d and: - Age > 70 - Hx renal disease/ckd/renal transplant - Diabetes - Pending creatinine value in lab 3 whole blood methods compared to reference - Roche Cobas Integra 400 (enzymatic, IDMS) - NIST SRM 967 used to verify reference method

37 Study population - Patient age: 68 ± 14 years (range 22-92) females, 163 males non African-American patients, 2 A-A patients

38 Study population - Patient age: 68 ± 14 years (range 22-92) females, 163 males non African-American patients, 2 A-A patients egfr calculated by MDRD formula - Including ethnicity, age and gender - Appropriate formula (IDMS or conventional) used - One method analyzed concordance with and without offset

39 Whole blood minus Plasma creatinine Bland-Altmann Plot of Radiometer vs. Plasma creatinine Whole blood and Plasma mean creatinine Mean bias mg/dl 95% results to 0.13 mg/dl

40 0.6 Bland-Altmann Plot of Method B vs. Plasma creatinine Whole blood minus Plasma creatinine Whole blood and Plasma mean creatinine Mean bias mg/dl 95% results to 0.29 mg/dl

41 Bland-Altmann Plot of Method C vs. Plasma Creatinine Whole blood minus Plasma Creatinine Whole blood and Plasma mean creatinine Mean bias mg/dl 95% results to 0.13 mg/dl

42 egfr concordance Radiometer Method C Method C offset Method B Plasma egfr < 60 (n=68) 55/68 (81%) 11/68 (16%) 40/68 (59%) 66/68 (97%) Plasma egfr 60 (n=198) 192/198 (97%) 198/198 (100%) 170/198 (86%) 166/198 (84%) Overall concordance 247/266 (93%) 199/266 (75%) 210/266 (79%) 232/266 (87%) Only Radiometer met criteria for egfr concordance (90%) and creatinine correlation (within 0.2 mg/dl)

43 What about patients missed with Radiometer? - 13/68 patients with plasma egfr < 60 called normal by Radiometer WB egfr - All 13 had plasma egfr > 45 ml/min/1.73 m 2 - All 13 had plasma creatinine 1.5 mg/dl - Likely low risk group for CIN Elderly patients with near-normal creatinine Demonstrates limitation of egfr in elderly

44 Decision to implement Radiometer for stat creatinine/egfr assessment - Performed in stat lab min TAT ~ 6 mo later Radiology second request, 2 high volume procedure areas off grid for sending to stat lab, request Method B in procedure area

45 Second study of Device B - 3 month clinical pilot of egfr screening using Device B - egfr 60 ml/min/1.73 m 2 proceed with contrast - egfr < 60 confirm by Radiometer, Integra (reference) if sample remained

46 Pilot results, Device B patients screened, 58 (27%) required confirmation - 25 samples measured on Device B and Integra Whole blood minus plasma creatinine (mg/dl) Bland-Altmann Plot of Method B vs. Plasma creatinine Whole blood and plasma mean creatinine (mg/dl) Mean bias mg/dl 14/25 (56%) samples with Method B egfr < 60 confirmed by Reference Both over and under estimation of creatinine by end users

47 Lessons learned from screening data - Trade-off between high specificity for detecting serum/plasma egfr < 60 and high number of discrepant results First study all comers 13% discordant results at cut-off of 60 for Method B, but high sensitivity Second study confirmation of Method B egfr < 60, over 40% of Method B egfr < 60 did not confirm by lab plasma egfr Cost/consequences of over estimating number of patients with mild renal impairment Consequences for procedure (alternative contrast, dollar cost) and after procedure End user performance may not duplicate study

48 Decision made to implement Method B in two areas with following protocol: - Method B egfr 60 proceed with contrast - Method B egfr change to alternative (safer) contrast Data shows 20-40% of time will be unnecessary as lab egfr 60 - Method B egfr < 45 confirm by Radiometer or lab plasma egfr Only 10% of patients expected to have Method B egfr < 45 ml/min/1.73 m 2

49 3319 patients with Radiometer 800 and Roche enzymatic creatinine same day serum egfr serum egrr serum egfr < 30 Mean (SD) creatinine bias mg/dl - Nearly identical to first study, device in use daily by lab techs

50 3319 patients with Radiometer 800 and Roche enzymatic creatinine same day - 94 % of Radiometer 800 results within 0.2 mg/dl of lab enzymatic result - Overall concorance ( 60, 30-59, < 30) between Radiometer and lab enzymatic for egfr classification 93% Over one year of routine use Radiometer 800 whole blood creatinine maintained correlation and concordance with lab enzymatic creatinine/egfr

51 131 samples had Radiometer 800, Method B, and lab enzymatic creatinine within one month Mostly Method B egfr < 45 ml/min/1.73 m 2 that required confirmation Do not represent overall population of patients being screened by radiology

52 Serum egfr 60 Serum egfr Serum egfr < 30 Number samples Rad egfr 60 Rad egfr Rad egfr < (96%) 1 (4%) (15%) 86 (84%) 1 (1%) (100%) Overall concordance 87%

53 Serum egfr 60 Serum egfr Serum egfr < 30 Number samples Method B egfr 60 Method B egfr Method B egfr < (73%) 7 (27%) (6%) 95 (93%) 1 (1%) (100%) Overall concordance 89% No difference between Radiometer and Method B

54 Measure correlation (creatinine) and concordance (egfr) with population to be screened Consider impact of discrepant egfr if screening low risk population - Small systematic bias can result in large number/percent discordant results Many devices may be effective at identifying patients at highest risk (egfr < 30 ml/min/1.73 m 2

55 Weighing sensitivity vs. specificity in WB creatinine at cut-off of 60 - Maximize sensitivity (overestimate creatinine) Pros: Safest practice, never miss a CKD patient Cons: Discordant creatinine/egfr values in medical record, overuse of more expensive contrast agents - Optimize sensitivity and specificity (best correlation) Pros: Fewer discrepant WB results, optimal use of contrast agents Cons: Some risk of missing mild CKD patients What is high risk population?

56 egfr is recommended for CKD screening

57 egfr is recommended for CKD screening CIN serious but can be prevented - System needed to identify at-risk patients - Whole blood POC creatinine may play a role

58 egfr is recommended for CKD screening CIN serious but can be prevented - System needed to identify at-risk patients - Whole blood POC creatinine may play a role Considerations in choosing WB creatinine - Concordance of egfr between WB and lab Especially if both reported in medical record - Sensitivity and specificity at desired egfr cut-off

59 Nichole Korpi-Steiner PhD Eric Williamson MD Amy Wockenfus Chris Koch Jan Lakin

60

61 National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Kidney Disease Outcome Quality Initiative. Am J Kidney Dis 2002; 39:S1-S246. Myers GL, Miller WG, Coresh J et al. Recommendations for improving serum creatinine measurement: a report from the laboratory working group of the National Kidney Disease Education Program. Clin Chem 2006; 52:5-18. Schweiger MJ, Chambers CE, Davidson CJ et al. Prevention of Contrast Induced Nephropathy:Recommendations for the High Risk Patient Undergoing Cardiovascular Procedures Catheterization and Cardiovascular Interventions 2007;69: Benko A, Fraser-Hill M, Magner P et al. Canadian Association of Radiologists:Consensus Guidelines for the Prevention of Contrast- Induced Nephropathy Can J Assoc Radiol 2007;58(2): Korpi-Steiner NL, Williamson EE, Karon BS. Comparison of Three Whole Blood Creatinine Methods for Estimation of Glomerular Filtration Rate Before Radiographic Contrast Administration Am J Clin Pathol 2009;132:920-6.

62 For a complete listing of upcoming and recorded educational events and resources, visit:

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