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Protocol - Alkaline Phosphatase

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Description:

The National Health and Nutrition Examination Survey (NHANES) 2007-2008 Laboratory Procedure Manual documents the steps to draw the respondent's blood, process and store the serum, and measure the concentration of alkaline phosphatase in international units per liter (IU/L ). The manual also includes information for safety precautions, quality control, and reference ranges for normal values.

Protocol:

The following is a summary version of the full National Health and Nutrition Examination Survey (NHANES) 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 Skin, Bone, Muscle and Joint Working Group: The investigator should record the reason a person is excluded from the blood draw.

Venipuncture Procedures

Please review chapter 4 of the Laboratory Procedures Manual from the National Health and Nutrition Examination Survey 2007–2008 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 Skin, Bone, Muscle and Joint Working Group: Blood should be collected in an appropriate 5-mL or 10-mL red-top tube or serum separator 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.

Blood Processing

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 whether the serum is hemolyzed, turbid, lipemic, or icteric. If so, enter a comment to describe the plasma.

Sample Storage

Note from the Skin, Bone, Muscle and Joint Working Group: Serum should be stored at -80C until testing and shipped on dry ice to prevent thawing.

Lab Assay for Serum Concentration of Alkaline Phosphatase

The Skin, Bone, Muscle and Joint Working Group recommends that alkaline phosphatase concentration be determined by a kinetic rate method. In this reaction, the concentration of the alkaline phosphatase is measured (in international units per liter; IU/L) by monitoring the ability of the enzyme to change a colorless organic phosphate substrate into a yellow colored product. The National Health and Nutrition Examination Survey 2007–2008 includes two examples of this method:

2007 –2008 NHANES Alkaline Phosphatase Lab Assay #1

2007–2008 NHANES Alkaline Phosphatase Lab Assay #2

Note from the Skin, Bone, Muscle and Joint Working Group: 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 for Alkaline Phosphatase*

Serum or Plasma
Age Group

IU/L

0–5 Y

60–321

5–10 Y

110–360

10–12 Y

103–373

12–16 Y

67–382

>16 Y

36–113

* From the National Health and Nutrition Examination Survey 2007–2008 laboratory protocol.

Protocol Name from Source:

The Expert Review Panel has not reviewed this measure yet.

Availability:

Publicly available

Personnel and Training Required

Phlebotomist and a medical technologist or laboratory technician who is trained and found to be competent (i.e., tested by an expert) in the conduct of bioassays.

Equipment Needs

Laboratory capable of performing the kinetic rate method for determination of alkaline phosphatase activity.

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:

Infant, Toddler, Child, Adolescent, Adult, Senior, Pregnancy

Participants:

Lifespan (infants to older adults)

Specific Instructions:

The Skin, Bone, Muscle and Joint Working Group recommends obtaining a total plasma alkaline phosphatase level when the presence of Paget's disease is suspected.

There are many methods used to obtain alkaline phosphatase values. The 2007–2008 National Health and Nutrition Examination Survey (NHANES) used both the Beckman Synchron LX20 and Beckman UniCel® DxC800 Synchron, which yielded comparable results. Regardless of the method used, it is critical to know the reference ranges for that method so that the user can interpret the results of the bioassay.

Selection Rationale

The National Health and Nutrition Examination Survey 2007–2008 manual was selected as the best standardized method for blood collection, sample processing and storage, and determination of alkaline phosphatase concentration.

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) Laboratory Procedure Alkaline Phosphatase Result Value 58313 CDE Browser
Logical Observation Identifiers Names and Codes (LOINC) Alkaline phosphatase proto 62898-2 LOINC
Derived Variables

None

Process and Review

The Expert Review Panel has not reviewed this measure yet.

Source

Centers for Disease Control and Prevention (CDC). National Center for Health Statistics (NCHS). (2007). National Health and Nutrition Examination Survey Laboratory Procedure Manual. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.

General References

None

Protocol ID:

170101

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX170101_Alkaline_Phosphatase_Concentration PX170101090000 Alkaline phosphatase concentration 4 N/A
PX170101_Assay_Repeatability PX170101070000 Repeatability of the assay 4 N/A
PX170101_Blood_Draw_Comments PX170101040200 Record any comments about the blood draw, including any reasons for the tube not being drawn according to the protocol. 4 Variable Mapping
PX170101_Blood_Draw_Done PX170101040000 Was blood drawn? 4 Variable Mapping
PX170101_Blood_Draw_Sample PX170101040100 Was full amount obtained? 4 Variable Mapping
PX170101_Chemotherapy PX170101020000 Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next four weeks? (exclusion from Phlebotomy) 4 N/A
PX170101_Coefficient_Of_Variation PX170101080000 Coefficient of variation for the assay 4 N/A
PX170101_Equipment_Make PX170101060100 Make of the equipment used to perform the alkaline phosphatase assay. 4 N/A
PX170101_Equipment_Manufacturer PX170101060200 Manufacturer of the equipment used to perform the alkaline phosphatase assay. 4 N/A
PX170101_Exclusion_Criteria PX170101030000 Exclusion Criteria 4 N/A
PX170101_Hemophilia PX170101010000 Do you have hemophilia? (exclusion from Phlebotomy) 4 Variable Mapping
PX170101_Sample_Comments PX170101050000 Record any comments about the sample during processing. 4 Variable Mapping
Research Domain Information
Measure Name:

Alkaline Phosphatase

Release Date:

November 12, 2010

Definition

This measure is a bioassay to determine the concentration of alkaline phosphatase in serum or plasma.

Purpose

This measure is used to determine the respondent's serum or plasma concentration of alkaline phosphatase in international units per liter (IU/L). An abnormal level of alkaline phosphatase is an indication of various conditions/diseases, such as liver and parathyroid disease. Alkaline phosphatase is also a marker of bone formation and as such is used to determine the presence of conditions that affect bone turnover, such as Paget's disease or vitamin D deficiency.

Keywords

alkaline phosphatase, Paget's disease, isoenzyme, liver disease, vitamin D deficiency, bone disease, bone formation, bone growth, parathyroid disease