Protocol - Cytokine Panel 12 - Assay
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
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 Category | Required |
---|---|
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
Standard | Name | ID | Source |
---|---|---|---|
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 VariablesVariable Name | Variable ID | Variable Description | dbGaP Mapping | |
---|---|---|---|---|
PX160201_Assay_Repeatability | ||||
PX160201080000 | Repeatability of the assay | N/A | ||
PX160201_Blood_Draw_Comments | ||||
PX160201040200 | Record any comments about the blood draw, more | 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 | 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 | N/A | ||
PX160201_Equipment_Make | ||||
PX160201070100 | Make of the equipment used to perform the more | N/A | ||
PX160201_Equipment_Manufacturer | ||||
PX160201070200 | Manufacturer of the equipment used to more | N/A | ||
PX160201_Exclusion_Criteria | ||||
PX160201030000 | Exclusion Criteria | N/A | ||
PX160201_Hemophilia | ||||
PX160201010000 | Do you have hemophilia? (exclusion from more | 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 | Variable Mapping | ||
PX160201_Tumor_Necrosis_Factor_Alpha_Concentration | ||||
PX160201200000 | Tumor Necrosis Factor - alpha | Variable Mapping |
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.