Gluten Immunogenic Peptide tests

Product code: KT-5739 iVYLISA GIP stool test. ELISA 96 wells.
Product code: KT-5737 iVYCHECK GIP stool test. Rapid test. 25 tests.
Product code: KT-6411 iVYCHECK GIP urine test. Rapid test. 25 tests.

Product code: KT-6414 GlutenDetect Home urine test. 1 test.
Product code: KT-6418 GlutenDetect Home urine test. 6 tests.
Product code: KT-6416 GlutenDetect Home urine test. 12 tests.
Product code: KT-6355 GlutenDetect Home stool test. 2 tests.

Gluten Immunogenic Peptide (GIP) Tests

Gluten Immunogenic Peptides (GIP) are fragments of gluten which are resistant to gastrointestinal digestion. These peptides trigger a series of immune reactions in coeliac patients. The resistance of GIP to gastrointestinal digestion results in significant levels of GIP excretion post gluten ingestion and therefore the presence of GIP in stool and urine samples is a reliable and direct marker for the accurate short and long-term control of the gluten-free diet (GFD).
Immunoassays based on G12 and A1 monoclonal antibodies, which react to 33-mer-like peptides of α-gliadin, the most immunogenic fragment of gluten enable very specific and sensitive detection and / or quantification of GIP in stool and urine samples as a direct marker of the adherence to a gluten-free diet.

Test for GIPs

GIP testing helps manage, and check, the adherence to a GFD and thus supports patients to reach a controlled and stabile state in disorders related to gluten sensitivity such as coeliac disease. GIP testing is recommended to predict and clarify adherence to GFD by collecting and testing three urine samples during a representative week. The frequency of positive GIP results correlates with the level of mucosal damage, with a triple-positive result showing an 83% probability of Marsh II-III. While patients who present a triple GIP negative result have a lower probability of intestinal damage (3%) compared to those with negative serology results (16%). This data indicates that the use of GIP testing is key in achieving a level of GFD adherence which should allow intestinal recovery.

Key Advantages

Simple, safe and non-invasive
Tests available for urine and stool samples
Results in as little as 15 minutes
Highly specific detection of Gluten in samples
Formats available for labs, clinics and home use

Specifications

Lateral flow test / ELISA

Multiple pack sizes available

Storage: 2-8 °C (ELISA) | Room temperature (LFTs)

Urine or Stool sample

More Details

Gluten Immunogenic Peptide Test Applications

The clinical utility of GIP detection in urine or stool samples has been demonstrated in several clinical trials and has now been adopted into several treatment pathways.
GIP testing helps manage, and check, the adherence to a GFD and thus supports patients to reach a controlled and stable state in disorders related to gluten sensitivity such as coeliac disease. The presence of symptoms, the use of dietary questionnaires, and serological testing are not reliable predictors of the level of gluten ingestion and can be hampered by subjective inaccuracies, GIP testing is recommended to predict and clarify adherence to GFD by collecting and testing three urine samples during a representative week. The frequency of positive GIP results correlates with the level of mucosal damage, with a triple-positive result showing an 83% probability of Marsh II-III. Conversely, patients who present a triple GIP negative result have a lower probability of intestinal damage (3%) compared to those with negative serology results (16%). This data indicates that the use of GIP testing is key in achieving a level of GFD adherence which should allow intestinal recovery.

GIP tests from BIOHIT

iVYLISA GIP Stool is a quantitative Sandwich ELISA kit designed for the detection and quantification of GIP in stool samples. High analytic sensitivity and specificity allow high quality quantification of GIP in a method that is easily scalable and automatable.

The iVYCHECK GIP products are immunochromatographic lateral flow tests (LFT) that detect the absence or presence of GIP in urine or stool samples, simplifying the evaluation of the patient in a few minutes.

When to use GIP tests

  • For the follow-up of gluten-free diets in coeliac and non-coeliac gluten sensitivity.
  • When symptoms have not been completely eliminated after following a gluten free diet.
  • During the first months after diagnosis to verify good dietary habits.
  • To evaluate gluten intake during Coeliac Disease follow-up and Refractory Celiac Disease diagnosis.
  • To prove Gluten Free Diet adherence or gluten challenge intake in clinical trials.

Gluten Immunogenic Peptides Tests FAQs

What are Gluten Immunogenic Peptides?

Gluten Immunogenic Peptides (GIP) are fragments of gluten which are resistant to gastrointestinal digestion. These peptides trigger a series of immune reactions in coeliac patients. The resistance of GIP to gastrointestinal digestion results in significant levels of GIP excretion post gluten ingestion and therefore the presence of GIP in stool and urine samples is a reliable and direct marker for the accurate short and long-term control of the gluten-free diet (GFD).

How do GIP tests work?

Immunoassays based on G12 and A1 monoclonal antibodies, which react to 33-mer-like peptides of alpha-gliadin, the most immunogenic fragment of gluten enable very specific and sensitive detection and / or quantification of GIP in stool and urine samples as a direct marker of the adherence to a gluten-free diet. BIOHIT supplies ELISA and lateral flow tests for detecting GIP in stool and urine.

Who should be tested for GIP?

Individuals who are on a gluten free diet can be tested for adherence and to detect any inadvertent consumption of gluten as part of their follow up. GIP tests can be used:

  • for follow-up of gluten-free diets in coeliac and non-coeliac gluten sensitivity;
  • when symptoms have not been completely eliminated after following a gluten free diet;
  • during the first months after diagnosis to verify good dietary habits;
  • to evaluate gluten intake during Coeliac Disease follow-up and Refractory Celiac Disease diagnosis;
  • to assess Gluten Free Diet adherence or gluten challenge intake in clinical trials.

How accurate are GIP tests?

iVYLISA GIP Stool test

  • Diagnostic sensitivity 97.1%
  • Diagnostic specificity 83.3%

iVYCHECK GIP Stool test

  • Diagnostic sensitivity  94.6%
  • Diagnostic specificity 100%

iVYCHECK GIP Urine test

  • Diagnostic sensitivity 90.18%
  • Diagnostic specificity 98.28%

 

Who can use the GIP Tests?

The GIP tests are user-friendly and suitable for laboratories, clinics and home (self-test) use. Our range of professional use only and home tests enable patients and practitioners to work in partnership in the management of their condition.

How often should GIP tests be used?

The test can be used for annual follow up or more frequently (e.g. monthly) for more intensive monitoring according to medical needs based on patient history, presentation and risk factors.

What do GIP test results mean?

According to recent clinical studies, when three urine samples are measured in the same week and the results are negative, there is more than a 97% chance that the intestine is in good condition. Similarly, two negative stool tests over a week would indicate good compliance with the gluten-free diet.

When a test result is positive it indicates that gluten has been consumed (>50mg).

Should we test urine or gluten for GIP?

For monitoring a gluten free diet, both types of test are equally effective. According to the Spanish Society of Celiac Disease, for effective control of a gluten free diet, 3 urine tests or 2 stool tests should be carried out within the same week every 3 or 6 months.

The urine test can detect gluten 2-15 hours after ingestion, while the stool test can detect it 1-6 days after ingestion.


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