Protocol - Celiac Sprue - Assay
Description
This protocol uses two-step serologic testing of serum to determine the presence of antihuman recombinant tissue transglutaminase (TTG) and endomysial antibody (EMA). When both tests are positive, the subject is notified that they are positive for celiac sprue. The test is most accurate if patients have not been on a gluten-free diet in the weeks leading up to the assay, as a gluten-free diet may cause the serologic assays to normalize in many patients.
Specific Instructions
Availability
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 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 SP answers "No" or "Dont Know," blood is drawn from the SP.
Note from the Gastrointestinal WG: The investigator should record the reason a person is excluded from the blood draw.
Venipuncture Procedures
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.
For a full description of phlebotomy procedures, please refer to Chapter 4 in the downloadable PDF of the 2009–2010 National Health and Nutrition Examination Survey (NHANES) Laboratory Procedures Manual available here: NHANES 2009-2010 Lab Manual
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.
For a full description of blood processing procedures, please refer to Chapter 8 in the downloadable PDF of the 2009–2010 National Health and Nutrition Examination Survey (NHANES) Laboratory Procedures Manual available here: NHANES 2009-2010 Lab Manual
The serum processing protocol is displayed in Exhibit 8.6.
Laboratory Assay
Note from the Gastrointestinal WG: Although there is not a standardized assay, there are a number of different kits that are appropriate to measure the concentration of TTG and EMA in serum. Once an assay is chosen for a particular study, the WG recommends that no changes in the protocol be made over the course of the study. To aid comparability, the Gastrointestinal WG recommends that the investigator record the make and manufacturer of equipment used and the repeatability and coefficients of variation for the assay.
Reference Intervals
TTG:
19 Units or less = Negative
20–30 Units = Weak Positive
31 Units or greater = Moderate to Strong Positive
EMA: < 1:10
Personnel and Training Required
A laboratory technician or phlebotomist who is trained and found to be competent (i.e., tested by an expert) in the conduct of bioassays.Equipment Needs
Phlebotomy supplies, laboratory to perform assaysRequirements
| 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
Child, Adolescent, Adult
Participants
Children, adolescents, and adults aged 6 years and older
Selection Rationale
The National Health and Nutrition Examination Survey (NHANES) 2009-2010 protocol was selected as the best practice methodology and is one of the most widely used research protocols.
Language
Chinese, English
Standards
| Standard | Name | ID | Source |
|---|---|---|---|
| Logical Observation Identifiers Names and Codes (LOINC) | Celiac sprue assay proto | 62957-6 | LOINC |
| Human Phenotype Ontology | Celiac Disease | HP:0002608 | HPO |
| caDSR Form | PhenX PX190301 - Celiac Sprue Assay | 6194969 | 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, 2009-2010
Source
Centers for Disease Control and Prevention (CDC). National Center for Health Statistics (NCHS). 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, 2009-2010.
General References
Dieterich, W., Ehnis, T., Bauer, M., Donner, P., Volta, U., Riecken, E. O., & Schuppan, D. (1997). Identification of tissue transglutaminase as the autoantigen of celiac disease. National Medicine, 3(7), 797–801.
Dieterich, W., Laag, E., Schopper, H., Volta, U., Ferguson, A., Gillett, H., Riecken, E. O., & Schuppan, D. (1998). Autoantibodies to tissue transglutaminase as predictors of celiac disease. Gastroenterology, 115(6), 1317–1321.
Green, P. H., Rostami, K., & Marsh, M. N. (2005). Diagnosis of coeliac disease. Best Practice and Research Clinical Gastroenterology, 19(3), 389–400.
Protocol ID
190301
Variables
Export Variables| Variable Name | Variable ID | Variable Description | dbGaP Mapping | |
|---|---|---|---|---|
| PX190301_Assay_Repeatability_EMA | ||||
| PX190301130000 | Repeatability of the assay for endomysial more | N/A | ||
| PX190301_Assay_Repeatability_TTG | ||||
| PX190301080000 | Repeatability of the assay for tissue more | N/A | ||
| PX190301_Assay_Type_EMA | ||||
| PX190301110000 | Record the type of assay used to perform the more | N/A | ||
| PX190301_Assay_Type_TTG | ||||
| PX190301060000 | Record the type of assay used to perform the more | N/A | ||
| PX190301_Blood_Draw_Comments | ||||
| PX190301040300 | Record any comments about the blood draw, more | Variable Mapping | ||
| PX190301_Blood_Draw_Done | ||||
| PX190301040100 | Was blood drawn? | Variable Mapping | ||
| PX190301_Blood_Draw_Sample | ||||
| PX190301040200 | Was full sample obtained? | N/A | ||
| PX190301_Chemotherapy | ||||
| PX190301020000 | Have you received cancer chemotherapy in the more | Variable Mapping | ||
| PX190301_Coefficient_Of_Variation_EMA | ||||
| PX190301140000 | Coefficient of variation for the assay for more | N/A | ||
| PX190301_Coefficient_Of_Variation_TTG | ||||
| PX190301090000 | Coefficient of variation for the assay for more | N/A | ||
| PX190301_EMA_Assay_Results | ||||
| PX190301150000 | Results of endomysial antibody antibody titer | N/A | ||
| PX190301_Equipment_Make_EMA | ||||
| PX190301120100 | Make of the equipment used to perform the more | N/A | ||
| PX190301_Equipment_Make_TTG | ||||
| PX190301070100 | Make of the equipment used to perform the more | N/A | ||
| PX190301_Equipment_Manufacturer_EMA | ||||
| PX190301120200 | Manufacturer of the equipment used to more | N/A | ||
| PX190301_Equipment_Manufacturer_TTG | ||||
| PX190301070200 | Manufacturer of the equipment used to more | N/A | ||
| PX190301_Exclusion_Criteria | ||||
| PX190301030000 | Exclusion Criteria | N/A | ||
| PX190301_Hemophilia | ||||
| PX190301010000 | Do you have hemophilia? | Variable Mapping | ||
| PX190301_Sample_Comments | ||||
| PX190301050000 | Record any comments about the sample during more | Variable Mapping | ||
| PX190301_TTG_Assay_Results | ||||
| PX190301100000 | Results of tissue transglutaminase antibody assay | N/A | ||
Measure Name
Celiac Sprue Assay
Release Date
December 13, 2010
Definition
This is a two-step serologic measure to determine whether a person is positive for celiac sprue, also known as gluten-sensitive enteropathy.
Purpose
The purpose of this measure is to determine the presence of celiac disease, an intolerance to dietary glutens that has protean manifestations. Surveys in other countries have found celiac sprue in about 0.5 percent to 1.0 percent of the population. Celiac sprue may well be as common in the United States, but it has not been adequately examined.
Keywords
Celiac, celiac sprue, celiac disease, gluten, TTG, EMA, transglutaminase, tissue transglutaminase, endomysial, endomysial antibody, NHANES, National Health and Nutrition Examination Survey, Bioassay, gluten-sensitive enteropathy, Gastrointestinal
Measure Protocols
| Protocol ID | Protocol Name |
|---|---|
| 190301 | Celiac Sprue - Assay |
Publications
There are no publications listed for this protocol.