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Will New Tests and Devices Change Celiac Diagnostics and Management?

Will new tests and devices change celiac diagnostics and diabetes management?


Will new tests change the way we diagnose and treat celiac disease and diabetes? Photo: CC--AJC1

Celiac.com 09/11/2017 - The FDA has granted clearance for Immco Diagnostics' ELISA for celiac disease, and for Roche's Benchtop Analyzer. What does that mean?

Immco's test is conducted as a solid phase immunoassay and is intended for the qualitative or semiquantitative detection of IgA or IgG antigliadin antibodies in human blood, and thus to aid in diagnosing patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings.

In other important diagnostic news, a benchtop analyzer from Roche Diagnostics and an immunoassay system from Shenzhen New Industries Biomedical was among the instruments and tests cleared by the US Food and Drug Administration in July, according to the agency. The FDA granted 510(k) clearance to Roche's Cobas b 101 instrument platform, as well as the Cobas HbA1c test. The fully automated and self-contained Cobas b 101 uses a single-use reagent disc to measure HbA1c from capillary and/or venous whole-blood samples, according to a document filed with the FDA.

The Cobas HbA1c is an in vitro diagnostic test for detecting the presence of glycate hemoglobin, which develops when hemoglobin joins with glucose in the blood, becoming 'glycated'. By measuring glycated hemoglobin (HbA1c), clinicians are able to get an overall picture of what our average blood sugar levels have been over a period of weeks/months.

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For people with diabetes this is important as the higher the HbA1c, the greater the risk of developing diabetes-related complications. The HbA1c assay is designed for use with the Cobas b 101 platform, which is not a portable home test, but is intended for a clinical laboratory or point-of-care setting.

Other instruments receiving FDA clearance in July include a new flow cytometer from Becton Dickinson; an expanded version of Bruker's MALDI Biotyper; and expanded indications for BioMérieux's Vitek MS MALDI-TOF Mass Spectrometery System. The FDA recently cleared the Maglumi 2000 automated immunoassay analyzer from Shenzhen New Industries Biomedical, which uses chemiluminescent technology for running IVD tests on clinical serum samples. The firm's Maglumi 2000 TSH assay for the quantitative determination of thyroid-stimulating hormone in human serum also received 510(k) clearance. The assay is for diagnosing thyroid disorders.

These are just a few of many new tests and analysis devices that are changing the way doctors diagnose and manage celiac disease, diabetes, and other diseases.

Look for tests like this to have a profound influence on the way diseases are diagnosed and managed in the future.

Read more: 360dx.com

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Interesting article. I do wonder how she was 'misdiagnosed' though and how she came to the conclusion she wasn't celiac.

Try dropping the oats for while and see if that helps. Some of us, myself included, react to even the ones that are certified as gluten free.

Hey guys, I appreciate the input, you are all very sweet and kind. I do not eat out at all. Only eat food I cook. No alcohol. Only certified gluten-free oats, grains, rice, etc. I have 3 roommates in a little house. I have my own gluten-free section to cook and prepare foo...

What was your gluten free diet like? I wonder if, when you were gluten-free, you went more whole food, less processed food? Or did you continue to eat processed food that was just gluten free? One reason I ask is that I have cut way back on grains and processed foods like gluten-free bread, but o...

Equal parts Hershey Coco Powder and a sweetener with a pinch of salt. Super easy to make your own. I like adding a bit to my coffee with almond milk, and lakanto sugar free maple, or a bit of monk fruit or stevia. PS you might want to drop dairy milk. The enzymes to break it down come from th...