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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).

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.

Availability

Available

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[ ]Dont Know

If the SP answers "Yes," the SP is excluded from the blood draw.

If the SP answers "No" or "Dont 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[ ]Dont Know

If the SP answers "Yes," the SP is excluded from the blood draw.

If the SP answers "No" or "Dont 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

Editors 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

Editors 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

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

Lifestage

Adolescent, Adult

Participants

Adolescents and adults, 12 years and older

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

Chinese, English, Other languages available at source

Standards
StandardNameIDSource
Logical Observation Identifiers Names and Codes (LOINC) Assay for cytokine panel 12 proto 62867-7 LOINC
Human Phenotype Ontology Abnormality of serum cytokine level HP:0011112 HPO
caDSR Form PhenX PX160201 - Assay For Cytokine Panel 12 6184957 caDSR Form
Derived Variables

None

Process and Review

Not applicable.

Protocol Name from Source

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

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 Name Variable IDVariable DescriptiondbGaP Mapping
PX160201_Assay_Repeatability
PX160201080000 Repeatability of the assay N/A
PX160201_Blood_Draw_Comments
PX160201040200 Record any comments about the blood draw, more
including any reasons for the tube not being drawn according to the protocol. show less
Variable Mapping
PX160201_Blood_Draw_Done
PX160201040000 Was blood drawn? Variable Mapping
PX160201_Blood_Draw_Sample
PX160201040100 Was full amount obtained? N/A
PX160201_Chemotherapy
PX160201020000 Have you received cancer chemotherapy in the more
past four weeks or do you anticipate such therapy in the next four weeks? (exclusion from Phlebotomy) show less
Variable Mapping
PX160201_Coefficient_Of_Variation
PX160201090000 Coefficient of variation for the assay N/A
PX160201_Cytokine_Assay_Type
PX160201060000 Record the type of assay used for cytokine more
testing. show less
N/A
PX160201_Equipment_Make
PX160201070100 Make of the equipment used to perform the more
cytokine assay. show less
N/A
PX160201_Equipment_Manufacturer
PX160201070200 Manufacturer of the equipment used to more
perform the cytokine assay. show less
N/A
PX160201_Exclusion_Criteria
PX160201030000 Exclusion Criteria N/A
PX160201_Hemophilia
PX160201010000 Do you have hemophilia? (exclusion from more
Phlebotomy) show less
Variable Mapping
PX160201_Interferon_Gamma_Concentration
PX160201120000 Interferon gamma N/A
PX160201_Interleukin_10_Concentration
PX160201150000 Interleukin 10 Variable Mapping
PX160201_Interleukin_12_Concentration
PX160201110000 Interleukin 12 N/A
PX160201_Interleukin_13_Concentration
PX160201160000 Interleukin 13 N/A
PX160201_Interleukin_1_Beta_Concentration
PX160201170000 Interleukin 1 beta N/A
PX160201_Interleukin_2_Concentration
PX160201210000 Interleukin 2 Variable Mapping
PX160201_Interleukin_2_Receptor_Concentration
PX160201100000 Interleukin 2 Receptor (Soluble) N/A
PX160201_Interleukin_4_Concentration
PX160201130000 Interleukin 4 N/A
PX160201_Interleukin_5_Concentration
PX160201140000 Interleukin 5 N/A
PX160201_Interleukin_6_Concentration
PX160201180000 Interleukin 6 Variable Mapping
PX160201_Interleukin_8_Concentration
PX160201190000 Interleukin 8 N/A
PX160201_Sample_Comments
PX160201050000 Record any comments about the sample during more
processing. show less
Variable Mapping
PX160201_Tumor_Necrosis_Factor_Alpha_Concentration
PX160201200000 Tumor Necrosis Factor - alpha Variable Mapping
Infectious Diseases and Immunity
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

Measure Protocols
Protocol ID Protocol Name
160201 Cytokine Panel 12 - Assay
Publications

There are no publications listed for this protocol.