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Protocol - Cytokine Panel 12 - Assay

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Protocol Name from Source:

The Expert Review Panel has not reviewed this measure yet.

Availability:

Publicly available

Description:

This protocol provides instructions for drawing, processing, and storing blood according to the National Health and Nutrition Examination Survey (NHANES) and uses the multi-analyte fluorescent detection (MAFD) method to measure 12┬┐different cytokines: Interferon gamma (IFN-gamma), Interleukin-1 beta (IL-1 beta), Interleukin-10 (IL-10), Interleukin-12 (IL-12), Interleukin-13 (IL-13), Interleukin-2 (IL-2), Interleukin-2 Receptor (IL-2R), Interleukin-4 (IL-4), Interleukin-5 (IL-5), Interleukin-6 (IL-6), Interleukin-8 (IL-8), Tumor Necrosis Factor alpha (TNF alpha).

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 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.

Note from the Infectious Diseases and Immunity Working Group (WG): 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 NHANES for a full description of phlebotomy procedures: [alink[NHANES_Lab_Manual.pdf|2007-2008 NHANES Lab Manual]].

Venipuncture should generally be performed using the median cubital, cephalic, or basilica 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 right arm/hand.

The Infectious Diseases and Immunity WG recommends that 3 mL serum be collected from each participant.

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 Infectious Diseases and Immunity WG: The Infectious Diseases and Immunity WG recommends that the investigator record whether the blood was drawn and whether the full amount was obtained.

Process the Sample for the Serum

Editor's Note: Please review chapter 8 of the Laboratory Procedures Manual from the NHANES 2007–2008 for a full description of Blood Processing procedures: [alink[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 describe the plasma.

Laboratory Assay for Cytokine Panel 12

The Infectious Diseases and Immunity WG recommend the multi-analyte fluorescent detection (MAFD) method of Cytokine Panel 12 offered through ARUP Laboratories.

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

Reference Interval

Components

Reference Interval

Interleukin-2 Receptor (Soluble) by MAFD

0–1,033 pg/mL

Interleukin-12 by MAFD

0–6 pg/mL

Interferon-gamma by MAFD

0–5 pg/mL

Interleukin-4 by MAFD

0–5 pg/mL

Interleukin-5 by MAFD

0–5 pg/mL

Interleukin-10 by MAFD

0–18 pg/mL

Interleukin -13 by MAFD

0–5 pg/mL

Interleukin-1 beta by MAFD

0–36 pg/mL

Interleukin-6 by MAFD

0–5 pg/mL

Interleukin-8 by MAFD

0–5 pg/mL

Tumor Necrosis Factor – alpha

0–22 pg/mL

Interleukin-2 by MAFD

0–12 pg/mL

Personnel and Training Required

Phlebotomist

Laboratory capable of performing multi-analyte fluorescent detection (MAFD)

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

Health Professional

Life Stage:

Adolescent, Adult

Specific Instructions:

The Infectious Diseases and Immunity Working Group notes that although the recommendation is for the multi-analyte fluorescent detection (MAFD) method of Cytokine Panel 12 offered through ARUP Laboratories, there are additional cytokines or other immunoactive molecules that may be selected according to the individual condition(s) being studied.

Research Domain Information

Release Date:

November 12, 2010

Definition

This is a bioassay to measure 12 different cytokines: Interferon gamma (IFN-gamma), Interleukin-1 beta (IL-1 beta), Interleukin-10 (IL-10), Interleukin-12 (IL-12), Interleukin-13 (IL-13), Interleukin-2 (IL-2), Interleukin-2 Receptor (IL-2R), Interleukin-4 (IL-4), Interleukin-5 (IL-5), Interleukin-6 (IL-6), Interleukin-8 (IL-8), Tumor Necrosis Factor alpha (TNF alpha).

Purpose

The measure is used for research purposes to understand the pathophysiology of immune, infectious, or inflammatory disorders.

Selection Rationale

The National Health and Nutrition Examination Survey (NHANES) 2007–2008 protocol was selected as the best standardized methodology for blood collection, processing, and storage.

Language

English, Spanish

Standards

StandardNameIDSource
Common Data Elements (CDE)Immunology Cytokine Panel 12 MAFD Assay Concentration in picograms per Milliliter3151332CDE Browser
Logical Observation Identifiers Names and Codes (LOINC)Assay for cytokine panel 12 proto62867-7LOINC

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 Questionnaire. Laboratory Procedures Manual. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.

ARUP Laboratories

500 Chipeta Way

Salt Lake City, UT 84108-1221

Phone: 800.242.2787

E-mail: clientservices@aruplab.com

General References

None

Protocol ID:

160201

Variables:

Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX160201_HemophiliaPX160201010000Do you have hemophilia? (exclusion from Phlebotomy)4Variable Mapping
PX160201_ChemotherapyPX160201020000Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next four weeks? (exclusion from Phlebotomy)4N/A
PX160201_Exclusion_CriteriaPX160201030000Exclusion Criteria4N/A
PX160201_Blood_Draw_DonePX160201040000Was blood drawn?4Variable Mapping
PX160201_Blood_Draw_SamplePX160201040100Was full amount obtained?4Variable Mapping
PX160201_Blood_Draw_CommentsPX160201040200Record any comments about the blood draw, including any reasons for the tube not being drawn according to the protocol.4Variable Mapping
PX160201_Sample_CommentsPX160201050000Record any comments about the sample during processing.4Variable Mapping
PX160201_Cytokine_Assay_TypePX160201060000Record the type of assay used for cytokine testing.4N/A
PX160201_Equipment_MakePX160201070100Make of the equipment used to perform the cytokine assay.4N/A
PX160201_Equipment_ManufacturerPX160201070200Manufacturer of the equipment used to perform the cytokine assay.4N/A
PX160201_Assay_RepeatabilityPX160201080000Repeatability of the assay4N/A
PX160201_Coefficient_Of_VariationPX160201090000Coefficient of variation for the assay4N/A
PX160201_Interleukin_2_Receptor_ConcentrationPX160201100000Interleukin 2 Receptor (Soluble)4N/A
PX160201_Interleukin_12_ConcentrationPX160201110000Interleukin 124N/A
PX160201_Interferon_Gamma_ConcentrationPX160201120000Interferon gamma4N/A
PX160201_Interleukin_4_ConcentrationPX160201130000Interleukin 44N/A
PX160201_Interleukin_5_ConcentrationPX160201140000Interleukin 54N/A
PX160201_Interleukin_10_ConcentrationPX160201150000Interleukin 104N/A
PX160201_Interleukin_13_ConcentrationPX160201160000Interleukin 134N/A
PX160201_Interleukin_1_Beta_ConcentrationPX160201170000Interleukin 1 beta4N/A
PX160201_Interleukin_6_ConcentrationPX160201180000Interleukin 64N/A
PX160201_Interleukin_8_ConcentrationPX160201190000Interleukin 84N/A
PX160201_Tumor_Necrosis_Factor_Alpha_ConcentrationPX160201200000Tumor Necrosis Factor - alpha4N/A
PX160201_Interleukin_2_ConcentrationPX160201210000Interleukin 24N/A