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Protocol - N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)

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Description:

This protocol provides instructions for drawing, processing, and storing blood according to the National Health and Nutrition Examination Survey (NHANES) methods. Because there are many comparable assays for ascertaining levels of N-terminal-pro-brain natriuretic peptide (NT-proBNP), the protocol also provides basic guidelines to aid comparability among different studies.

Protocol:

Summary of the N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Assay

The following is a summary version of the full National Health and Nutrition Examination Survey 2011-2012 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 answers "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 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 2011-2012 National Health and Nutrition Examination Survey (NHANES) for a full description of phlebotomy procedures. This manual is posted here, and is also available at the NHANES website: 2011-2012 NHANES Laboratory Procedures 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.

Blood Processing

Please review chapter 8 of the Laboratory Procedures Manual from the National Health and Nutrition Examination Survey 2011-2012 for a full description of blood processing procedures: 2011-2012 NHANES Laboratory Procedures Manual

• Centrifuge the tube at room temperature to separate the plasma and aliquot into an appropriate storage tube.

• Determine if the plasma is hemolyzed, turbid, lipemic, or icteric. If so, enter a comment to describe the plasma.

Laboratory Assay for NT-proBNP

NT-proBNP can be measured using a two-step sandwich enzyme-linked immunosorbent assay (ELISA) in streptavidin-coated microtitre plates. The Sickle Cell Disease Cardiovascular, Pulmonary, and Renal Working Group notes that there are a number of different reagents and instruments that are appropriate to measure the concentration of NT-proBNP. Once an assay is chosen for a particular study, the Working Group recommends that no changes in the protocol be made over the course of the study. To aid comparability, the 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

Age

Range (pg/mL)

< 50 years old

300 - 450

50-75 years old

300 - 900

>75 years old

300 - 1800

Protocol Name from Source:

This section will be completed when reviewed by an Expert Review Panel.

Availability:

Publicly available

Personnel and Training Required

A phlebotomist, nursing staff, or other health care professional who is trained to draw blood and laboratory staff who are trained to perform this assay.

Equipment Needs

Phlebotomy supplies, centrifuge for serum separation, and freezer for sample storage is required.

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Bioassay

Life Stage:

Adult

Participants:

Adults, ages 18 and older

Specific Instructions:

The National Health and Nutrition Examination Survey (NHANES) instructions for drawing, processing, and storing blood provide a standard methodology used successfully for many years to ensure comparable results across study sites. However, the Sickle Cell Disease Working Group 1 (Cardiovascular, Pulmonary, and Renal) notes that certain aspects (e.g., exclusion criteria) of the NHANES protocol are study specific and might not be applicable to all types of studies (e.g., sickle cell disease). Investigators who want to include participants that have hemophilia or have received cancer chemotherapy in the last 4 weeks will need to implement special venipuncture procedures.

N-terminal-pro-brain natriuretic peptide (NT-proBNP) analysis is performed by plasma assay.

Selection Rationale

The Sickle Cell Disease Cardiovascular, Pulmonary, and Renal Working Group selected N-terminal-pro-brain natriuretic peptide (NT-proBNP) measurement because it is a validated, specific, low-burden, and non-invasive alternative to echocardiography for differentiating patients with ventricular dysfunction. Additionally, this assay does not require sample extraction and there is no detectable cross reactivity with atrial natriuretic peptide (ANP), N-terminal pro-atrial natriuretic peptide (NT-proANP), brain natriuretic peptide (BNP), or urodilatin.

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) N-Terminal Fragment Brain Natriuretic Protein Laboratory Procedure Performed Outcome Integer::1 Decimal Place Nanogram per Liter Value 4155192 CDE Browser
Process and Review

This section will be completed when reviewed by an Expert Review Panel.

Source

Centers for Disease Control and Prevention (CDC). (2011). 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.

Bay, M., Kirk, V., Parner, J., Hassager, C., Nielsen, H., Krogsgaard, K., Trawinski, J., Boesgaard, S., & Aldershvile, J. (2003). NT-proBNP: A new diagnostic screening tool to differentiate between patients with normal and reduced left ventricular systolic function. Heart, 89, 150-154.

General References

Karl, J., Borgya, A., Gallusser, A., Huber, E., Krueger, K., Rollinger, W. & Schenk, J. (1999). Development of a novel, N-terminal-proBNP (NT-proBNP) assay with a low detection limit. Scandinavian Journal of Clinical and Laboratory Investigation, 59(Suppl230), 177-181.

Machado, R. F., Anthi, A., Steinberg, M. H., Bonds, D., Sachdev, V., Kato, G. J., Taveira-DaSilva, A. M., Ballas, S. K., Blackwelder, W., Xu, X., Hunter, L., Barton, B., Waclawiw, M., Castro,O., Gladwin, M. T., & MSH Investigators. (2006). N-Terminal Pro-Brain Natriuretic Peptide Levels and Risk of Death in Sickle Cell Disease. JAMA, 296(3), 310-318. doi:10.1001/jama.296.3.310

Machado, R. F., Hildesheim, M., Mendelsohn, L., Remaley, A. T., Kato, G. J., & Gladwin, M. T. (2011). NT-pro brain natriuretic peptide levels and the risk of death in the cooperative study of sickle cell disease. British Journal of Haematology, 154(4), 512-520.

Pfister, R., & Schneider, C. A. (2008). ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2008: application of natriuretic peptides. European Heart Journal, 382-383.

Tamizifar, B., & Rismankarzadeh, M. (2012). Using NT-proBNP as a criterion for heart failure hospitalization. Journal of Research in Medical Sciences, 17(1): 111-113.

Protocol ID:

810501

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX810501_NTerminalProBrainNatriureticPeptide_NTProBNP_Age PX810501030000 Age 4 N/A
PX810501_NTerminalProBrainNatriureticPeptide_NTProBNP_Assay_Repeatability PX810501110000 Repeatability of the NT-proBNP assay 4 N/A
PX810501_NTerminalProBrainNatriureticPeptide_NTProBNP_Blood_Draw_Results PX810501040000 Record the results of the blood draw. 4 N/A
PX810501_NTerminalProBrainNatriureticPeptide_NTProBNP_Blood_Draw_Tube_Deviation PX810501050000 Record reasons for a tube not being drawn according to the protocol. 4 N/A
PX810501_NTerminalProBrainNatriureticPeptide_NTProBNP_Chemotheraphy_4weeks PX810501020000 Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next four weeks? 4 N/A
PX810501_NTerminalProBrainNatriureticPeptide_NTProBNP_Coefficients_Variation_Assay PX810501120000 Coefficients of variation of the NT-proBNP assay 4 N/A
PX810501_NTerminalProBrainNatriureticPeptide_NTProBNP_Concentration PX810501080000 NT-proBNP concentration 4 N/A
PX810501_NTerminalProBrainNatriureticPeptide_NTProBNP_Equipment_Make PX810501090000 Make of the equipment used to perform the NT-proBNP assay 4 N/A
PX810501_NTerminalProBrainNatriureticPeptide_NTProBNP_Equipment_Manufacturer PX810501100000 Manufacturer of the equipment used to perform the NT-proBNP assay 4 N/A
PX810501_NTerminalProBrainNatriureticPeptide_NTProBNP_Hemophilia PX810501010000 Do you have hemophilia? 4 N/A
PX810501_NTerminalProBrainNatriureticPeptide_NTProBNP_Plamsa_Description PX810501070200 If plasma is hemolyzed, turbid, lipemic, or iteric, then describe. 4 N/A
PX810501_NTerminalProBrainNatriureticPeptide_NTProBNP_Plamsa_Determination PX810501070100 Determine if the plasma is hemolyzed, turbid, lipemic, or icteric. 4 N/A
PX810501_NTerminalProBrainNatriureticPeptide_NTProBNP_Venipuncture_Comments PX810501060000 Record any comments about the venipuncture. 4 N/A
Research Domain Information
Measure Name:

N-terminal Pro-brain Natriuretic Peptide (NT-proBNP)

Release Date:

July 30, 2015

Definition

A bioassay to determine an individual’s level of N-terminal pro-brain natriuretic peptide (NT-proBNP).

Purpose

N-terminal pro-brain natriuretic peptide (NT-proBNP) is released from the right or left ventricle of the heart when it is under increased strain related to volume or pressure overload. Levels of NT-proBNP can be used as a screening tool to evaluate an individual’s left and right ventricular function. Elevated NT-proBNP levels can be used diagnostically in decompensated congestive heart failure and they can be followed longitudinally to understand response to therapy. In patients with pulmonary hypertension and acute pulmonary embolism, elevated levels reflect an increased risk of morbidity and mortality. Additionally, in patients with sickle cell disease, levels of NT-proBNP levels > 160 pg/ml predict increased mortality risk.

Keywords

N-terminal pro-brain natriuretic peptide, NT-proBNP, left ventricular ejection fraction, LVEF, sickle cell disease, SCD, chronic heart failure, pulmonary hypertension, PH, biomarkers, immunoassay