Loading…

Protocol - Celiac Sprue - Assay

Add to My Toolkit
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
It is important that the patients screened with this laboratory assay are eating a diet that contains dietary sources of gluten in order for the assay to be most accurate. Sources of dietary gluten include the grains wheat, rye, and barley. The Gastrointestinal Working Group (WG) also recommends performing the immunoglobulin A (IgA) and immunoglobulin G (IgG) antibody tests for more sensitivity. The National Health and Nutrition Examination Survey (NHANES) uses red-top tubes to collect 0.5 ml serum for the antihuman recombinant tissue transglutaminase (TTG)/ endomysial antibody (EMA) bioassay. However, the Gastrointestinal Working Group recommends consulting the laboratory that will perform the bioassay regarding the appropriate collection tubes to use.
Availability

Available

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 assays
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

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
StandardNameIDSource
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 IDVariable DescriptiondbGaP Mapping
PX190301_Assay_Repeatability_EMA
PX190301130000 Repeatability of the assay for endomysial more
antibody titer show less
N/A
PX190301_Assay_Repeatability_TTG
PX190301080000 Repeatability of the assay for tissue more
transglutaminase antibody show less
N/A
PX190301_Assay_Type_EMA
PX190301110000 Record the type of assay used to perform the more
determination of endomysial antibody titer show less
N/A
PX190301_Assay_Type_TTG
PX190301060000 Record the type of assay used to perform the more
determination of tissue transglutaminase antibody. show less
N/A
PX190301_Blood_Draw_Comments
PX190301040300 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
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
past four weeks or do you anticipate such therapy in the next four weeks? show less
Variable Mapping
PX190301_Coefficient_Of_Variation_EMA
PX190301140000 Coefficient of variation for the assay for more
endomysial antibody titer show less
N/A
PX190301_Coefficient_Of_Variation_TTG
PX190301090000 Coefficient of variation for the assay for more
tissue transglutaminase antibody show less
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
determination of endomysial antibody antibody titer show less
N/A
PX190301_Equipment_Make_TTG
PX190301070100 Make of the equipment used to perform the more
determination of tissue transglutaminase antibody show less
N/A
PX190301_Equipment_Manufacturer_EMA
PX190301120200 Manufacturer of the equipment used to more
perform the determination of endomysial antibody antibody titer show less
N/A
PX190301_Equipment_Manufacturer_TTG
PX190301070200 Manufacturer of the equipment used to more
perform the determination of tissue transglutaminase antibody. show less
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
processing. show less
Variable Mapping
PX190301_TTG_Assay_Results
PX190301100000 Results of tissue transglutaminase antibody assay N/A
Gastrointestinal
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.