Reflective Practive

Gastrointestinal disease

Differentiating between GI conditions, the symptoms of which are very similar, can be difficult and frustrating for both patients and healthcare professionals; laboratory investigations should be used to help differentiate between GI conditions, potentially reducing the time to diagnosis.1-7 The tests available to support the diagnosis of gastrointestinal disease are:

EliA Celikey IgA (14-5517-01)

EliA Celikey IgA has a virtually identical performance compared to EMA, but is fully automated8 Study included a total of 150 patients (95 coeliac disease patients; 55 control patients (32 affected by respiratory disease; 23 affected by digestive disease)

Cut-off/measuring range

Negative Equivocal Positive Measuring range
EliA Celikey IgA <7 U/ml 7-10 U/ml >10 U/ml 0.1-≥128 U/ml

Coating

  • Human recombinant tissue transglutaminase IgA produced in the baculovirus/insect cell system

Dilution

  • 1:100

Sample material

  • Serum, plasma (EDTA, citrate)

EliA Celikey IgG (14-5518-01)

EliA Celikey IgG has comparable sensitivity with the highest specificity in coeliac disease patients with selective IgA deficiency9 IgG anti-tTG antibodies in 20 patients with coeliac disease and IgA deficiency and in 113 controls (9 patients with IgA deficiency without coeliac disease, 54 patients with chronic liver disease, and 50 healthy individuals) Adapted from Villata D, et al. 2007 - maunfacturers' cutoff.

Cut-off/measuring range

Negative Equivocal Positive Measuring range
EliA Celikey IgG <7 U/ml 7-10 U/ml >10 U/ml 0.6-≥600 U/ml

Coating

  • Human recombinant tissue transglutaminase IgG produced in the baculovirus/insect cell system

Dilution

  • 1:100

Sample material

  • Serum, plasma (EDTA, citrate)

EliA GliadinDP IgG (14-5538-01)

EliA Celikey IgA and EliA GliadinDP IgG - the ideal combination for coeliac disease testing10 Internal study included a total of 349 patients (98 coeliac disease patients; 248 controls)

Cut-off/measuring range

Negative Equivocal Positive Measuring range
EliA GliadinDP IgG <7 U/ml 7-10 U/ml >10 U/ml 0.4-≥302 U/ml

Coating

  • Deamidated gliadin peptide IgG

Dilution

  • 1:100

Sample material

  • Serum, plasma (EDTA, citrate, heparin)

EliA GliadinDP IgA (14-5519-01)

EliA GliadinDP IgA and IgG are highly sensitive in young children; children below 12 months may have insufficient tTG antibodies for a reliable diagnosis11

Cut-off/measuring range

Negative Equivocal Positive Measuring range
EliA GliadinDP IgA <7 U/ml 7-10 U/ml >10 U/ml 0.2-≥213 U/ml

Coating

  • Deamidated gliadin peptide IgG

Dilution

  • 1:100

Sample material

  • Serum, plasma (EDTA, citrate, heparin)

EliA Calprotectin 2 (14-6748-01)

EliA Calprotectin 2 has outstanding performance10 Performance of EliA Calprotectin 2 and four other tests in 99 symptomatic IBD patients and 83 controls with FBD; internal study

Cut-off/measuring range

Negative Positive Measuring range
EliA Calprotectin 2 ≤50 mg/kg >50 mg/kg 3.8-≥6000 mg/kg
The extensive measuring range can allow clinicians to monitor the progress of patients with high initial faecal calprotectin, e.g. if a patient presents with a faecal calprotectin of 5500 mg/kg, receives treatment and a second result is 3500 mg/kg; the treatment is clearly working however, without the extended measuring range the clinician would not know the precise reduction.

Coating

  • Mouse monoclonal antibodies to calprotectin

Dilution

  • 1:200

Sample material

  • Human stool

EliA ASCA IgA/IgG (14-5633-01 / 14-5635-01)

EliA ASCA is a fully automated, specific, and clinically relevant test10 Performance data of EliA ASCA IgA + IgG and tests from two other suppliers in 100 ulcerative colitis patients; internal study

Cut-off/measuring range

Negative Equivocal Positive Measuring range
EliA ASCA IgA <7 U/ml 7-10 U/ml >10 U/ml 0.8-≥237 U/ml
EliA ASCA IgG <7 U/ml 7-10 U/ml >10 U/ml 0.5-≥240 U/ml

Coating

  • Mannan of Saccharomyces cerevisiae

Dilution

  • 1:100

Sample material

  • Human serum or plasma (EDTA, citrate herparin)

Cut-off/measuring range, coating, dilution and sample material have been taken from respective Phadia 250 DFUs. The data is intended as a guide and should be treated accordingly. If you have any questions or uncertainty please contact your local service team or Laboratory Sales Representative.

References
  1. Waugh N, et al. Health Technology Assessment 2013; 17.
  2. Green PHR, et al. Am J Gastroenterol 2001; 96(1): 126-131.
  3. Jatla M, et al. Pract Gastroenterol 2008; 32(4): 18-34.
  4. Van Assche G, et al. J Crohns Colitis 2010; 4: 7-27.
  5. National Health Service: Irritable bowel syndrome (IBS) - Symptoms. 2013. Available from: http://www.nhs.uk/Conditions/Irritable-bowel-syndrome/Pages/Symptoms.aspx; last accessed May 2014.
  6. National Institute for Health and Care Excellence. Coeliac Disease: recognition, assessment and management (NG20). 2015. London: National Institute for Health and Care Excellence.
  7. National Institute for Health and Care Excellence. NICE pathways - Irritable bowel syndrome in adults. Available from http://pathways.nice.org.uk/pathways/irritable-bowel-syndrome-in-adults; last accessed May 2014.
  8. Brusca I, et al. CLin Chem Lab Med 2012; 50(1): 111-117.
  9. Villata D, et al. Clinica Chemica Acta 2007; 382: 95-99.
  10. Thermo Fisher Scientific. Internal study.
  11. Lagerqvist C, et al. J Pediatr Gastroenterol 2008; 47(4): 428-435.

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