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Protocol - Cytokine Panel 12 - Assay

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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) 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: 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: 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

Protocol Name from Source:

The Expert Review Panel has not reviewed this measure yet.

Availability:

Publicly available

Personnel and Training Required

Phlebotomist

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

Equipment Needs

Phlebotomy supplies

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:

Adolescent, Adult

Participants:

Adolescents and adults, 12 years and older

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.

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 Milliliter 3151332 CDE Browser
Logical Observation Identifiers Names and Codes (LOINC) Assay for cytokine panel 12 proto 62867-7 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 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_Assay_Repeatability PX160201080000 Repeatability of the assay 4 N/A
PX160201_Blood_Draw_Comments PX160201040200 Record any comments about the blood draw, including any reasons for the tube not being drawn according to the protocol. 4 Variable Mapping
PX160201_Blood_Draw_Done PX160201040000 Was blood drawn? 4 Variable Mapping
PX160201_Blood_Draw_Sample PX160201040100 Was full amount obtained? 4 Variable Mapping
PX160201_Chemotherapy PX160201020000 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
PX160201_Coefficient_Of_Variation PX160201090000 Coefficient of variation for the assay 4 N/A
PX160201_Cytokine_Assay_Type PX160201060000 Record the type of assay used for cytokine testing. 4 N/A
PX160201_Equipment_Make PX160201070100 Make of the equipment used to perform the cytokine assay. 4 N/A
PX160201_Equipment_Manufacturer PX160201070200 Manufacturer of the equipment used to perform the cytokine assay. 4 N/A
PX160201_Exclusion_Criteria PX160201030000 Exclusion Criteria 4 N/A
PX160201_Hemophilia PX160201010000 Do you have hemophilia? (exclusion from Phlebotomy) 4 Variable Mapping
PX160201_Interferon_Gamma_Concentration PX160201120000 Interferon gamma 4 N/A
PX160201_Interleukin_10_Concentration PX160201150000 Interleukin 10 4 N/A
PX160201_Interleukin_12_Concentration PX160201110000 Interleukin 12 4 N/A
PX160201_Interleukin_13_Concentration PX160201160000 Interleukin 13 4 N/A
PX160201_Interleukin_1_Beta_Concentration PX160201170000 Interleukin 1 beta 4 N/A
PX160201_Interleukin_2_Concentration PX160201210000 Interleukin 2 4 N/A
PX160201_Interleukin_2_Receptor_Concentration PX160201100000 Interleukin 2 Receptor (Soluble) 4 N/A
PX160201_Interleukin_4_Concentration PX160201130000 Interleukin 4 4 N/A
PX160201_Interleukin_5_Concentration PX160201140000 Interleukin 5 4 N/A
PX160201_Interleukin_6_Concentration PX160201180000 Interleukin 6 4 N/A
PX160201_Interleukin_8_Concentration PX160201190000 Interleukin 8 4 N/A
PX160201_Sample_Comments PX160201050000 Record any comments about the sample during processing. 4 Variable Mapping
PX160201_Tumor_Necrosis_Factor_Alpha_Concentration PX160201200000 Tumor Necrosis Factor - alpha 4 N/A
Research Domain Information
Measure Name:

Cytokine Panel 12 - Assay

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.

Keywords

Infectious disease, Cytokines, Immunity, Immunomodulating agents, Interleukin, Bioassay, National Health and Nutrition Examination Survey, NHANES, Infectious Diseases and Immunity