No popular authors found.


Get Celiac.com's E-Newsletter

Categories

No categories found.







Ads by Google:


Questions? Join Our Forum:
~1 Million Posts
& Over 66,000 Members!



SHARE THIS PAGE:
Celiac.com Sponsors:

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.

Ads by Google:

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

Celiac.com welcomes your comments below (registration is NOT required).












Related Articles



Comments




Rate this article and leave a comment:
Rating: * Poor Excellent
Your Name *: Email (private) *:




In Celiac.com's Forum Now:


An autoimmune disease can occur when the body's immune system mistakenly perceives a nonthreatening substance. In the case of people with celiac disease, gluten (a protein found in wheat, barley, rye, and oats) is seen as a foreign invader and is attacked by the immune system. This immune system ...

Might consider my approach of a dairy free keto diet with very limited meat intake. I live off of omelettes with veggies, veggie stir fries nut based breads, nut butters, seeds, avocados, coconut, coconut wraps, nut based milks and cheeses instead of dairy, and I tend to have Kal nutritional yeas...

Thank u for replying, My gp said the high normal is 10 and I am 41. Waiting to have my biopsy done. Have been so Ill since last December with lots of neurological problems have had brain mri and have a small lesion on my brain but not necciserily connected to ms but have to have a repeat scan. Af...

Well, while not being a dairy product for Psoriatic people we are very limited to meat products so better option for me would be vegan.

Oh, the description said it was crispy but didn't realize it would be hard, what about this one? https://www.walmart.com/ip/4C-Gluten-Free-Plain-Crumbs-12-oz/39096467?wmlspartner=wlpa&adid=22222222227026826600&wl0=&wl1=g&wl2=c&wl3=43010521232&wl4=aud-310687321802:pla-81548181392&wl5=9004416&...