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Enzyme linked immunosorbent assays (ELISA) for the qualitative detection of IgA anti-gliadin antibodies in human serum to aid in the diagnosis of patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings Enzyme linked immunosorbent assays (ELISA) for the qualitative detection of IgG anti-gliadin antibodies in human serum to aid in the diagnosis of patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings

This test is performed as a solid phase immunoassay. Microwells are coated with antigen. Controls, calibrators and patient sera are incubated in the antigen coated wells to allow specific antibodies present in the serum to bind to the gliadin antigen. Bound antibodies are detected by adding an enzyme labeled anti-human IgA or IgG conjugate. Specific enzyme substrate (TMB) is then added and the presence of antibodies is detected by a color change that is read by a spectrophotometer at 450 mm. Results are expressed in ELISA units per milliliter (EU/ml) and reported as positive or negative.

AESKULISA DGP-Check is an in-vitro diagnostic device. This solid phase enzyme immunassay employs synthetic, deemicated gliadin-derived pertides for the combined seniqualitative detation of 194 and 195 and 195 and 195 and its deamical desirical d Gliadin-specific peptides (DGP) in human serum. The assay is an aid in the diac disease (gluter-sensitive enteropatiy) and should be used in conjunction with ather serological tests and clinical findings. AESKULISA DGP-G is an in-vitro diagnostic device This salid phase enzyme immuncessay employs synthetic, deamicated gliadin-derived peptides for the semiquantitative and qualitative detection of IgG antibodies against deamidded Gliadin-specific peptides (DGP) in human serum. The assy is an aid in the diegnosis of celies disease (gluter-sensitive enteropedly) and should be used in conjunction with other serological tests and clinical findings. AESKULISA DGP-A is an in-vitro diagnostic device. This solid phase enzyme immunossay employs synthetic, deamidated gliadin-derived peptides for the semiqualitative and qualitative detection of 1gA antibodies against deaminded Gliadin-specific peptides (DGP) in human serum. The assay is an aid in the diagnosis of cellac disease (gluter-sensitive enteropathy) and should be used in corjunction with other serological tests and clinical findings.

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The a-Gliatest® IgA is intended for the semi-quantitative determination of IgA antibodies directed against gliadin in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings. The a-Gliatest® IgG is intended for the semi-quantitative determination of IgG antibodies directed against gliadin in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings. The a-GliaPep® IgA is intended for the semi-quantitative determination of IgA antibodies directed against deamidated gliadin peptide in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings. The a-GliaPep® IgG is intended for the semi-quantitative determination of IgG antibodies directed against deamidated gliadin peptide in human serum. The assay is an aid in the diagnosis of celiac disease and should be used in conjunction with other serological tests and clinical findings.

Each test kit for a-Gliatest® IgA, a-Gliatest® IgG, a-GliaPep® IgA, and a-GliaPep® IgG consists of one (1) microtiter plate (12 strips of 8 microwells coated with purified a-gliadin antigen or deamidated gliadin peptide antigen), assay controls (positive and negative), a ready-to-use set of five (5) calibrators, Horseradish Peroxidase (HRP) goat anti-human IgA or IgG conjugate, serum diluent, Tetramethylbenzidine (TMB) enzyme substrate, stop solution, and washing solution required for the assay.

The QUANTA Flash™ DGP IgA is a chemiluminescent immunoassay for the semi-quantitative determination of of IgA antibodies to synthetic, deamidated gliadin peptides in human serum. The measurement of IgA deamidated gliadin peptide antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of celiac disease and dermatitis herpetiformis. The QUANTA Flash™ DGP IgG is a chemiluminescent immunoassay for the semi-quantitative detection of IgG antibodies to synthetic, deamidated gliadin peptides in human serum. The measurement of IgG deamidated gliadin peptide antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of celiac disease in IgA deficient and IgA deficient patients, as well as dermatitis herpetiformis. The QUANTA Flash DGP IgA Calibrators are intended for use with the QUANTA Flash DGP IgA chemiluminescent immunoassay (CIA). Each calibrator establishes a point of reference for the working curve that is used to determine Chemiluminescent Unit (CU) values in the measurement of IgA anti-DGP antibodies in serum. The QUANTA Flash DGP IgA Calibrators are intended for use with the QUANTA Flash DGP IgA chemiluminescent immunoassay (CIA). Each calibrator establishes a point of reference for the working curve that is used to determine Chemiluminescent Unit (CU) values in the measurement of IgA anti-DGP antibodies in serum. The QUANTA Flash DGP IgA Controls are intended for quality control purposes of the QUANTA Flash DGP lgA chemiluminescent immunoassay (CIA) kit run on the BIO FLASH® instrument that is used for the measurement of IgA anti-deamidated gliadin peptide (DGP) antibodies in human serum. The QUANTA Flash DGP IgG Controls are intended for quality control purposes of the QUANTA Flash DGP IgG chemiluminescent immunoassay (CIA) kit run on the BIO FLASH® instrument that is used for the measurement of IgG anti-deamidated gliadin peptide (DGP) antibodies in human serum.

Synthetic deamidated gliadin peptide is coated onto the surface of paramagnetic beads (microparticles), which are stored in the reagent cartridge under conditions that preserve the antigen in its reactive state. The reagent cartridge is then loaded onto and used by the BIO-FLASH instrument. Serum samples are prediluted by the instrument with system rinse buffer, and added to disposable plastic cuvettes. Small amounts of the diluted patient serum, the DGP beads, and assay buffer are all combined into a second cuvette, and mixed. This cuvette is incubated at 37℃. The beads are then magnetized and washed several times. Isoluminol conjugated anti-human IgA (or IgG) antibody is then added to the cuvette, and incubated at 37°C. Again, the beads are magnetized and washed repeatedly. The isoluminol conjugate produces a luminescent reaction when reagents ("Triggers") are added to the cuvette. The light produced from this reaction is measured as Relative Light Units (RLU) by the BIO-FLASH optical system. The RLU are proportional to the amount of bound isoluminol conjugate, which in turn is proportional to the amount of anti-DGP antibodies bound to the DGP on the beads. For quantitation, the QUANTA Flash DGP IgA and IgG assays utilize a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge barcode. Every new lot number of reagent cartridge must be calibrated before first use with the QUANTA Flash DGP IgA and IgG Calibrators. Based on the results obtained with the two Calibrators included in the Calibrator set, an instrument specific Working Curve is created, which is used to calculate chemiluminescent units (CU) from the RLU obtained for each patient. The QUANTA Flash DGP IgA reagent cartridge contains the following reagents: - DGP coated paramagnetic beads in buffer, containing protein stabilizers and a. preservative. - Assay buffer colored pink, containing Tris-buffered saline, Tween 20, protein b. stabilizers and preservatives. - Tracer IgA Isoluminol labeled anti-human IgA antibodies in buffer, containing protein ن stabilizers and preservative. The QUANTA Flash DGP IgG reagent cartridge contains the following reagents: - DGP coated paramagnetic beads in buffer, containing protein stabilizers and a. preservative. - Assay buffer colored pink, containing Tris-buffered saline, Tween 20, protein ﻗ stabilizers and preservatives. - Tracer IgG Isoluminol labeled anti-human IgA antibodies in buffer, containing protein ﻥ stabilizers and preservative. The QUANTA Flash™ DGP IgA Calibrators and the QUANTA Flash™ DGP IgG Calibrators kits each contain 2 vials of Calibrators: QUANTA Flash™ DGP IgA Calibrators: - QUANTA Flash DGP IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives. - QUANTA Flash DGP IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL . prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives. QUANTA Flash™ DGP IgG Calibrators: - QUANTA Flash DGP IgG Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL . prediluted, ready to use reagent. Calibrators contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives. - QUANTA Flash DGP IgG Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives. The QUANTA Flash™ DGP IgA Controls kit and the QUANTA Flash™ DGP IgG Controls kits each contain 2 vials of Negative Control and two vials of Positive Control: QUANTA Flash™ DGP IgA Controls: QUANTA Flash™ DGP IgA Negative Control: Two (2) barcode labeled tubes containing 0.5 ml, ready to use reagent. Controls contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives. QUANTA Flash™ DGP IgA Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives. QUANTA Flash™ DGP IgG Controls: QUANTA Flash™ DGP IgG Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives. QUANTA Flash™ DGP IgG Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human IgG antibodies to DGP in buffer, protein stabilizers, and preservatives.

The QUANTA Flash™ DGP Screen is a chemiluminescent immunoassay (CIA) for the semiquantitative detection of IgG and IgA anti-deamidated gliadin peptide (DGP) antibodies in human serum on the BIO-FLASH® instrument. It is an aid in the diagnosis of celiac disease and dermatitis herpetiformis in conjunction with clinical findings and other laboratory tests. The QUANTA Flash™ DGP Screen Calibrators are intended for use with the QUANTA Flash™ DGP Screen chemiluminescent immunoassay (CIA) kit run on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used to determine Chemiluminescent Unit (CU) values in the measurement of IgG and IgA anti-DGP antibodies in serum. The QUANTA Flash™ DGP Screen Controls are intended for quality control purposes of the QUANTA Flash™ DGP Screen chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument.

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EliA™ Gliadinºº IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA™ Gliadin47 IgG uses the EliA IgG method on the instruments Phadia® 100 and Phadia® 250. EliA™ Gliadinºº IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to gliadin in serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings. EliA™ Gliadinºº IgA uses the EliA IgA method on the instruments Phadia® 100 and Phadia® 250.

The new devices belong to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments Phadia 100 and Phadia 250. The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate. The conjugate for the EliA IgA method is mouse anti-human IgA beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate. The total IgG and IgA calibration is based on a set of six WHO-standardized IgG and IgA Calibrators, respectively, derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method-specific and general reagents that are packaged as separate units.

Enzyme linked immunosorbent assay (ELISA) for the qualitative and semi-quantitative detection of IgA or IgG antibodies to qliadin in human serum to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings.

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The Anti-Gliadin (GAF-3X) ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of IgA class antibodies against gliadin in human serum. It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.

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The Anti-Gliadin (GAF-3X) ELISA (IgA) test kit is intended for the qualitative determination of IgA class antibodies against gliadin in human serum. It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.

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These assays are designed for the in-vitro measurement of specific IgG or IgA antibodies against a modified gliadin peptide (MGP) in human serum, as an aid in the diagnosis of coeliac disease in conjunction with other clinical and laboratory findings.

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