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Protocol - Serum Creatinine - Assay

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Protocol Name from Source:

2007 National Health and Nutrition Examination Survey (NHANES) Laboratory Procedures Manual

Availability:

Publicly available

Description:

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.

Protocol:

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 the SP answers "No" or "Don’t Know," blood is drawn from the SP.

2. Have you received cancer chemotherapy in the past 4 weeks or do you anticipate such therapy in the next 4 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 the SP answers "No" or "Don’t Know," blood is drawn from the SP.

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. [link[www.phenxtoolkit.org/toolkit_content/supplemental_info/diabetes/additional_info/NHANES_Lab_Manual.pdf|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.

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.

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: [link[www.phenxtoolkit.org/toolkit_content/supplemental_info/diabetes/additional_info/NHANES_Lab_Manual.pdf|2007-2008 NHANES Lab Manual]].

• Allow the blood to clot by setting aside for 30-45 minutes at room temperature. Do not clot for more than 1 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 d 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 S Reference Ranges*

Serum or Plasma Age Group

mg/dl

Male

Female

0-1 month

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

Serum or Plasma Age Group

mg/dl

Male

Female

0-1 month

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 National Health and Nutrition Examination Survey (NHANES) protocol for Serum Creatinine.

Personnel and Training Required

Phlebotomist Laboratory that can perform the Jaffe rate method

Equipment Needs

Phlebotomy supplies

Requirements

Requirement CategoryRequired
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingNo

Mode of Administration

Self-administered

Life Stage:

Child, Adolescent, Adult

Specific Instructions:

The Diabetes Working Group (WG) notes that the Serum Creatinine assay can be done in conjunction with cystatin C assay (see Diabetes Supplemental Information [link[www.phenxtoolkit.org/toolkit_content/supplemental_info/diabetes/additional_info/Cystatin_C_Assay_for_Kidney_Function.doc|Cystatin C]]) to yield more information about kidney disease (Levey, 2014).

Note from the Diabetes WG: Blood should be collected in an appropriate 5 mL or 10 mL red-top tube.

Note from the Diabetes WG: The investigator should record the reason a person is excluded from the blood draw.

Note from the Diabetes WG: The DW Group recommends that the investigator record whether the blood was drawn and whether the full amount was obtained.

Note from the Diabetes WG: Serum should be stored at -80°C until testing and shipped on dry ice to prevent thawing.

To aid comparability, the Diabetes WG recommends that the investigator record the make and manufacturer of equipment used and the repeatability and coefficients of variation for the assay.

Note from the Expert Review Panel: Plasma or Serum

Collection of blood samples for the measurement of analytes requires a general determination of whether to use serum or plasma for the assay and also a determination of the type of collection tube to be obtained. For example, if serum is to be used, a determination needs to be made as to whether red-top or serum gel separator collection tubes are used. While comparable values are obtained for many analytes from either serum or plasma, there may be situations where differences are more pronounced and serum- or plasma-specific norms will be needed for references. The protocol presented here uses red-top/serum separator tubes. At times, it may be possible to collect both, but other considerations, such as participant burden, may be the deciding factor. It is important to match assay type with sample type. Some automated devices may preclude the use of serum, for example, while others may be optimized for it. Investigators should choose methods of collection that match the methods of analysis. This will best be done by communicating with the laboratory where the proposed assays will be performed. The laboratory will become an important partner with you in assuring that there is compatibility from collection to assays to interpretation and reporting of levels and results.

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.

Research Domain Information

Release Date:

October 1, 2015

Definition

A bioassay to measure the serum concentration of creatinine, a metabolite of muscle creatine that is filtered out of blood by the kidneys.

Purpose

Serum creatinine concentration is the most standardized way to calculate glomerular filtration rate (GFR) as a measure of kidney function.

Selection Rationale

The National Health and Nutrition Examination Survey (NHANES) 2007-2008 protocol was selected as the best practice methodology and one of the most widely used protocols to measure serum creatinine.

Language

English, Spanish

Standards

StandardNameIDSource
Common Data Elements (CDE)Hematology Serum Creatinine Laboratory Result Value in mg/dL2655822CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)Serum creatinine assay proto62807-3LOINC

Process and Review

The [link[phenx.org/node/62|Expert Review Panel #1]] reviewed the measures in the Anthropometrics, Diabetes, Physical Activity and Physical Fitness, and Nutrition and Dietary Supplements domains.

Guidance from the ERP includes:

• Changed name of measure

• Added recommendations on use of serum or plasma

Back-compatible: no changes to Data Dictionary

Previous version in Toolkit archive ([link[www.phenxtoolkit.org/index.php?pageLink=browse.archive.protocols&id=140000|link]])

Source

Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS). (2007). 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.

General References

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.

American Diabetes Association (ADA). (2014). Diagnosis and classification of diabetes mellitus. Diabetes Care, 37(Suppl. 1), S81-S90.

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.

Levey, A. S., Inker, L. A., & Coresh, J. (2014). GFR estimation: From physiology to public health. American Journal of Kidney Diseases, 63(5), 820-834.

Miles, R. R., Roberts, R. F., Putnam, A. R., & Roberts, W. L. (2004). Comparison of serum and heparinized plasma samples for measurement of chemistry analytes [Letter to the Editor]. Clinical Chemistry, 50(9), 1704-1705.

Protocol ID:

141401

Variables:

Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX141401_HemophiliaPX141401010000Do you have hemophilia?4Variable Mapping
PX141401_ChemotherapyPX141401020000Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next four weeks?4N/A
PX141401_Exclusion_CriteriaPX141401030000Exclusion Criteria4N/A
PX141401_Blood_Draw_DonePX141401040100Was blood drawn?4Variable Mapping
PX141401_Blood_Draw_SamplePX141401040200Was full sample obtained?4Variable Mapping
PX141401_Blood_Draw_CommentsPX141401040300Record any comments about the blood draw, including any reasons for the tube not being drawn according to the protocol.4Variable Mapping
PX141401_Sample_CommentsPX141401050000Record any comments about the sample during processing.4Variable Mapping
PX141401_Equipment_MakePX141401060000Make of the equipment used to determine the concentration of serum creatinine.4N/A
PX141401_Equipment_ManufacturerPX141401060100Manufacturer of the equipment used to determine the concentration of serum creatinine.4N/A
PX141401_Assay_RepeatabilityPX141401070000Repeatability of the assay4N/A
PX141401_Coefficient_Of_VariationPX141401080000Coefficient of variation for the assay4N/A
PX141401_Serum_Creatinine_ConcentrationPX141401090000Serum Creatinine Concentration4N/A