Serum Creatinine Assay for Kidney Function
Protocol Id
141401
Version #
1
Description of
Protocol
This protocol provides instructions for drawing, processing and storing blood
for the serum creatinine assay according to the National Health and Nutrition
Examination Survey (NHANES) methods. Creatinine concentration in a
participant’s serum is measured according to the Jaffe rate method.
Specific
Instructions
The Diabetes Working Group notes that the Serum Creatinine assay can be
done in conjunction with Cystatin C assay (see Diabetes Supplemental
Information Cystatin C) to yield more information about kidney disease. In
particular, comparing and contrasting the polymorphisms associated with
each assay can identify "true" markers for kidney function (see Kottgen et
al., 2009 for more information).
The Sickle Cell Disease Research and Scientific Panel cautions about relying
only on the serum creatinine to detect renal insufficiency in sickle cell
disease. Because of low muscle mass and an increase in the tubular secretion
of creatinine in this disease, a serum creatinine in the normal range does not
rule out renal insufficiency (low glomerular filtration rate, GFR) and
overestimates the level of GFR. Estimation equations of GFR, widely used in
clinical practice, have been derived from non-sickle cell disease populations
and lack precision to estimate GFR in sickle cell disease. Based on studies in
non-African-American SCD populations, the Chronic Kidney Disease
Epidemiology Collaboration (CKD-EPI) equation without adjustment for
ethnicity (Artlet, et al., 2012) may offer the best estimate of GFR in adults,
until sickle cell disease specific eGFR equations are developed.
Protocol Text
The following is a summary version of the full National Health and Nutrition
Examination Survey 2007-2008 protocol.
Exclusion Criteria
Persons will be excluded from this component if they:
• Report that they have hemophilia; or
• Report that they have received cancer chemotherapy in the last 4 weeks
SP= Sample Person.
1. Do you have hemophilia?
1
[]
Yes
2
[]
No
7
[]
Refused
9
[]
Don’t Know
If the SP answers, "Yes," the SP is excluded from the blood draw.
If SP answer "No" or "Don’t Know," blood is drawn from the SP.
2. Have you received cancer chemotherapy in the past four weeks or do you
anticipate such therapy in the next four weeks?
1
[]
Yes
2
[]
No
7
[]
Refused
9
[]
Don’t Know
If the SP answers, "Yes," the SP is excluded from the blood draw.
If SP answer "No" or "Don’t Know," blood is drawn from the SP.
Note from the Diabetes Working Group: The investigator should record the
reason a person is excluded from the blood draw.
Venipuncture Procedures
Editor’s Note: Please review chapter 4 of the Laboratory Procedures Manual
from the National Health and Nutrition Examination Survey for a full
description of Phlebotomy procedures. 2007-2008 NHANES Lab Manual.
Venipuncture should generally be performed using the median cubital,
cephalic, or basilic veins in the left arm unless this arm is unsuitable. If the
veins in the left arm are unsuitable, look for suitable veins on the right arm.
If the veins in the antecubital space on both arms are not suitable, then look
for veins in the forearm or dorsal side of the hand on the left arm/hand and
then the right arm/hand.
Note from the Diabetes Working Group: Blood should be collected in an
appropriate 5- or 10-mL red-top tube.
Recording the Results of the Venipuncture Procedure
Immediately after completing the venipuncture, record the results of the
blood draw, the reasons for a tube not being drawn according to the
protocol, and any comments about the venipuncture.
Note from the Diabetes Working Group: The Diabetes Working Group
recommends that the investigator record whether the blood was drawn and
whether the full amount was obtained.
Process the Sample for the Serum Creatinine Assay
Editor’s Note: Please review chapter 8 of the Laboratory Procedures Manual
from the National Health and Nutrition Examination Survey 2007-2008 for a
full description of Blood Processing procedures: 2007-2008 NHANES Lab
Manual.
• Allow the blood to clot by setting aside for 30 to 45 minutes at room
temperature. Do not clot for more than an hour.
• Centrifuge the tube at room temperature to separate the serum and
aliquot into an appropriate storage tube.
• Determine if the serum is hemolyzed, turbid, lipemic, or icteric. If so,
enter a comment to describe the plasma.
Note from the Diabetes Working Group: Serum should be stored at -80°C
until testing and shipped on dry ice to prevent thawing.
Laboratory Assay for Serum Creatinine
The Diabetes Working Group recommends that serum creatinine
concentration be determined according to the Jaffe rate method used in the
National Health and Nutrition Examination Survey: 2007-2008 NHANES Serum
Creatinine Lab Assay.
To aid comparability, the Diabetes Working Group recommends that the
investigator record the make and manufacturer of equipment used and the
repeatability and coefficients of variation for the assay.
Reference Ranges*
Serum or Plasma mg/dl
Age Group
Male
0-1 month
Female
0.3-0.8
1 month - 1 Year
0.3-0.6
1-15 Years
0.3-1.0
Older than 15
Years
0.7-1.3
0.6-1.1
*From the NHANES protocol for Serum Creatinine
Selection
Rationale
The NHANES 2007-2008 protocol was selected as the best practice
methodology and one of the most widely used protocols to measure serum
creatinine.
Source
Centers for Disease Control and Prevention (CDC). National Center for Health
Statistics (NCHS). National Health and Nutrition Examination Survey
Questionnaire. Laboratory Procedures Manual. Hyattsville, MD: U.S.
Department of Health and Human Services, Centers for Disease Control and
Prevention, 2007.
Language
English, Spanish
Participant
Participant 6 years of age or older.
Personnel and
Training
Required
Phlebotomist
Laboratory that can perform the Jaffe rate method
Equipment Needs Phlebotomy supplies
Standards
General
References
Standard
Name
ID
Source
Common Data Elements
(CDE)
Hematology Serum
Creatinine Laboratory Result
Value in mg/dL
2655822 CDE Browser
Logical Observation
Identifiers Names and
Codes (LOINC)
Serum creatinine assay proto
62807-3 LOINC
American Diabetes Association. (2010). Diagnosis and classification of
diabetes mellitus. Diabetes Care, 33 (Supplement 1), S11 - S61.
Kottgen A, Glazer NL, Dehghan A, Hwang SJ, Katz R, Li M, Yang Q, Gudnason
V, Launer LJ, Harris TB, Smith AV, Arking DE, Astor BC, Boerwinkle E, Ehret
GB, Ruczinski I, Scharpf RB, Ida Chen YD, de Boer IH, Haritunians T, Lumley
T, Sarnak M, Siscovick D, Benjamin EJ, Levy D, Upadhyay A, Aulchenko YS,
Hofman A, Rivadeneira F, Uitterlinden AG, van Duijn CM, Chasman DI, Par�,
Ridker PM, Kao WH, Witteman JC, Coresh J, Shlipak MG, & Fox CS. (2009).
Multiple loci associated with indices of renal function and chronic kidney
disease. Nature Genetics. 41(6), 712-717
Allon, M., Lawson, L., Eckman, J.R., Delaney, V., & Bourke, E. (1988).
Effects of nonsteroidal antiinflammatory drugs on renal function in sickle cell
anemia. Kidney International, 34, 500-506.
Arlet, J.B., Ribeil, J.A., Chatellier, G., Eladari, D., De Seigneux, S.,
Souberbielle, J.C., Friedlander, G., de Montalembert, M., Pouchot, J.,
Pri�D., & Courbebaisse, M. (2012) Determination of the best method to
estimate glomerular filtration rate from serum creatinine in adult patient
with sickle cell disease: a prospective observational cohort study. BMC
Nephrology, 13, 83
de Jong, P.E., de Jong-Van Den Berg, T.W., Sewrajsingh, G.S., Schouten, H.,
Donker, A.J.M., & Statius van Eps, L.W. (1980). The influence of
indomethacin on renal hemodynamics in sickle cell anemia. Clinical Science,
59, 245-250.
Guasch, A., Cua, M., & Mitch, W.E. (1996). Early detection and the course of
glomerular injury in patients with sickle cell anemia. Kidney International,
49, 786-791.
Protocol Type
Bioassay
Derived Variables Estimated Glomerular Filtration Rate (eGFR):
For Creatinine in mg/dL:
Estimated Glomerular Filtration Rate = 186 X Serum Creatinine
Age -.203 X [1.210 if African American] X [0.742 if Female]
-1.154
X
For Creatinine in umol/L:
Estimated Glomerular Filtration Rate = 32788 X Serum Creatinine
Age -.203 X [1.210 if African American] X [0.742 if Female]
-1.154
X
Levey, AS, Bosch, JP, Lewis, JB, Greene, T, Rogers, N, & Roth D. (1999). A
more accurate mehtod to estimate glomerular filtration rate from serum
creatinine: a new prediction equation. Modification of Diet in Renal Disease
Study Group. Annals of Internal Medicine. 130(6), 461-470.
Requirements
Requirement Category
Required
Average time of greater than 15 minutes in an unaffected individual
No
Average time of greater than 15 minutes in an unaffected
individual
Major equipment
This measure requires a specialized measurement device that
may not be readily available in every setting where genome wide
No
association studies are being conducted. Examples of specialized
equipment are DEXA, Echocardiography, and Spirometry
Specialized requirements for biospecimen collection
No
This protocol requires that blood, urine, etc. be collected from
the study participants.
Specialized training
This measure requires staff training in the protocol methodology
and/or in the conduct of the data analysis.
No