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Elia celikey iga

Manufactured by Thermo Fisher Scientific
Sourced in United States, Sweden

The EliA Celikey IgA is a laboratory equipment product designed to detect the presence of immunoglobulin A (IgA) antibodies associated with celiac disease. It serves as a diagnostic tool to aid in the identification of celiac disease.

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6 protocols using elia celikey iga

1

Celiac Serology Assays Comparison

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All diagnostic patient sera were tested with QUANTA Flash  h-tTG IgA from Inova Diagnostics (San Diego, USA) and with EliA Celikey  IgA from Thermo Fisher Scientific (Uppsala, Sweden). The latter analyses were performed in batch on stored serum samples (-18°C).
QUANTA Flash  h-tTG IgA analyses were performed on the BIO-FLASH  (Inova Diagnostics, San Diego, USA) fully automated chemiluminescent immunoassay (CLIA) analyzer. In this assay, purified recombinant human tTG (QUANTA Flash  h-tTG IgA) coated on paramagnetic beads is used as antigen and will react with antibodies from the patient's serum sample. The optical system of the analyzer measures the light induced by the antigen-antibody reaction in relative light units (RLU) and, after conversion, expresses results as chemiluminescent units (CU). The cut-off set by Inova Diagnostics for IgA anti-h-tTG antibody positivity is 20 CU.
The Phadia 250 analyzer (Thermo Fisher Scientific, Uppsala) was used to perform the EliA Celikey  IgA assays. Phadia 250 is an automated fluorescence enzyme immunoassay (FEIA) analyzer. Human recombinant tissue transglutaminase is used as antigen in this assay.
According to the manufacturer's instructions, the cut-off value of the EliA Celikey  IgA assay is 7 U/mL. Test result specific likelihood ratios were calculated using the Bézier method as described in Bossuyt et al. (26) (link).
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2

Quantifying tTG IgA Levels in Celiac Disease

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IgA tTG at the time of diagnosis were processed at various outpatient laboratories. Values are reported here as multiples of the upper limit of normal (ULN) for the assay used.
For serum samples collected at the time of endoscopy, the tTG IgA level was measured at MGH using QUANTA Lite Rh-tTG IgA ELISA using INOVA Quanta Flash on BIO-flash (INOVA Diagnostics, San Diego, CA, USA) with a ULN of 20 U/mL. Samples collected at clinical visits were tested using EliA Celikey IgA (Thermofisher Scientific, Waltham, MA) with a ULN of 6.9 U/mL.
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3

Celiac Disease Serological Diagnosis

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Serum IgA tissue anti-transglutaminase antibodies (tTG) (or IgG tTG in IgA-deficient patients) were analyzed using homologated commercial quantitative automated ELISAs while the patients were on a gluten-containing diet at the time of the diagnosis (during the 23 years considered for patient recruitment). Depending on the center, Elia Celikey IgA (Thermo Fisher, Phadia AB, Uppsala, Sweden), Aeskulisa tTg-A (Aesku Diagnostics, Wendelsheim, Germany), or Bioplex 2200 Celiac IgA (Bio-Rad, Hercules, CA, USA) were mainly used. Little change in sensitivity was expected. Serum anti-endomysium IgA antibodies (EmA) were tested by an IF assay at a dilution of 1:5 in commercial sections of primate distal esophagus as the antigen substrate (Immco Diagnostics, Buffalo, NY, USA) to confirm a positive result in all samples analyzed with the Aeskulisa tTG-A kit. In the remaining centers, EmA was tested in patients with either borderline anti-tTG or detectable anti-tTG titers that were below the cut-off suggested by the manufacturer to confirm positive celiac serology.
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4

Serological Biomarkers for Celiac Disease

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Detection of IgA anti-TG2, IgA anti-GL, and Immunoglobulin G (IgG) anti-DGP in serum or plasma was performed using EliA Celikey IgA (positive result ≥ 7 U/mL), EliA Gliadin IgA (positive result ≥ 7 U/mL), and EliA GliadinDP IgG (positive result ≥ 10 U/mL), respectively, on Phadia250 (Thermo Fisher Scientific, Waltham, MA) as described by the manufacturer. In cases with total IgA levels below 0.07 g/L, detection of IgG anti-TG2 replaced IgA anti-TG2 (EliA Celikey IgG, Thermo Fisher Scientific). In order to distinguish results below the detection limit of an assay from missing data, the former were replaced with the detection limit divided by two.
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5

Serological Testing for Celiac Disease

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Serum IgA tTG (or IgG tTG in IgA deficient patients) was analysed using homologated commercial quantitative automated ELISAs while the patients were on a gluten-containing diet. Depending on the centre, EliA Celikey IgA (Thermo Fisher, Phadia AB, Uppsala, Sweden), Aeskulisa tTg-A (Aesku.Diagnostics, Wendelsheim, Germany) or Bioplex 2200 Celiac IgA (BioRad, Hercules, CA, USA) were used. Serum EmA was tested by an IF assay at dilution 1:5 in commercial sections of primate distal oesophagus as the antigen substrate (Immco Diagnostics, Buffalo, NY, USA) to confirm a positive result in all samples analysed with the Aeskulisa tTg-A kit. In the remaining centres, EmA was tested in patients with either borderline anti-tTG titres or detectable anti-tTG titres, but below the cut-off suggested by the manufacturer.
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6

Evaluation of Celiac Disease Diagnostics

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The tTG IgA reference test was EliA Celikey IgA (Thermo Scientific, Phadia GmbH), a FEIA used widely by clinical laboratories. Total IgA was measured with an accredited in-house method of HUSLAB (Hospital District of Helsinki and Uusimaa, Laboratory Services, Finland). If the total IgA measurement was indicative of selective IgA deficiency, tTG IgG was measured by EliA Celikey IgG (Thermo Scientific, Phadia GmbH).
A commercial rapid lateral flow test (Celiac Disease Quick Test, Biohit) for anti-tTG antibodies performed according to the manufacturer’s instructions was used as an additional reference.
All statistical analyses were performed with R version 3.5.1.
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