No popular authors found.
Ads by Google:

Categories

No categories found.


Get Celiac.com's E-Newsletter





Ads by Google:


Follow / Share


  FOLLOW US:
Twitter Facebook Google Plus Pinterest RSS Podcast Email  Get Email Alerts
SHARE:

Popular Articles

No popular articles found.
Celiac.com Sponsors:

FDA Approves First Fully Automated Gliadin Tests with Deamidated Peptides for Celiac Disease


Important new FDA approval of celiac disease testing.

Celiac.com 10/20/2010 - U.S. doctors and patients looking for accurate early diagnosis of celiac disease now have a state of the art celiac disease assay with a high level of sensitivity and specificity. The US Food and Drug Administration (FDA) has given 510(k) clearance for the first two fully automated gliadin tests featuring deamidated peptides for celiac disease.

Manufactured by Phadia US, the tests, EliA GliadinDP IgA and EliA GliadinDP IgG, are designed to be used in conjunct with other laboratory and clinical findings in the early diagnosis of celiac disease.

According to Gabi Gross, autoimmune franchise leader for Phadia US, "EliA GliadinDP IgA and EliA GliadinDP IgG will offer physicians who suspect a possible case of celiac disease, antibody tests with the lowest number of false positive results." This means less "unnecessary endoscopies and biopsies," she adds.

Ads by Google:

EliA GliadinDP IgA and EliA GliadinDP IgG will offer antibody tests with the lowest number of false positive results for doctors who suspect a patient has celiac disease.

The assays are optional on Laboratory Systems Phadia 100Є and Phadia 250 instruments with features like quick turnaround, monthly calibration, onboard instrument dilution, and a discrete single-well, random-access, nonmicrotiter plate format.

Phadia also manufactures other approved CLIA moderately complex assays in the EliA autoimmune product line, including anticardiolipin IgG/IgM, anti-B2-glycoprotein 1 IgG/IgM, cyclic citrullinated peptide, tissue transglutaminase IgA/ IgG, gliadin IgA/IgG, dsDNA, antinuclear antibody screen, and ENA antibodies to the following antigens: Sm, U1RNP, RNP70, Ro, La, Scl-70, CENP, and Jo-1.

Source:


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












4 Responses:

 
Jeff Kelly
Rating: ratingfullratingfullratingfullratingemptyratingempty Unrated
said this on
24 Oct 2010 7:59:19 PM PDT
Lowest number of false positives? I don't see how this beats the stool antibody tests developed by Kenneth Fine, MD of Dallas, Texas and his Enterolab.
There simply AREN'T any really good antibody tests besides his yet it seems. Physicians and patients need to recognize this and Physicians especially need to stop living in a fantasy world on accurate tests for Celiac.

 
April
Rating: ratingfullratingfullratingfullratingemptyratingempty Unrated
said this on
03 Nov 2010 3:58:13 AM PDT
Blood test are not accurate. Daughter diagnosed 4 years ago from a biopsy and then the blood test to confirm. I did a blood test and I was negative. My mother was negative as well. However, 3 years down the road, my mother had genetic testing done to see if she had the gene(s) for celiac. She does! She has both the genes. Resulting in ME having it 100%. My point here is blood test are so not accurate.

 
kiki
Rating: ratingfullratingfullratingfullratingfullratingfull Unrated
said this on
23 Oct 2011 7:12:09 PM PDT
Your mother can have the gene and not develop the disease, and the same goes for you. The blood tests they do is to see if you in fact have the disease, not the gene.

 
Reeny
Rating: ratingfullratingfullratingfullratingemptyratingempty Unrated
said this on
29 Mar 2013 5:02:07 AM PDT
Test does not state whether person needs to be consuming gluten prior to testing. What's the truth of the matter? Where can I find solid facts? Thanks.




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




In Celiac.com's Forum Now:


Before ordering the endoscopy, you would think they would order the complete celiac panel. Not all celiacs (like me) ever get a positive TTG (I do test positive to the DGP, but negative to the EMA and TTG). You would think that the additional blood tests would be way more cost effective than go...

Hello linzk8! I would suggest you to go with natural foods as you are allergic to latex. One of my friends had the same problem. She also had latex allergic. She used Indian nuts to lose weight purchased from the official site of Nuez Dela India and achieved a success. You can also check the same...

My family visited Peru (my 13 year old has celiac) last Christmas, and we found Peru rather gluten free friendly. Peru is the land of corn and potatoes, and they have lots of grill meats. Their cooking ingredients tend to be naturally gluten-free. We did the 4 day Inca trail hike to Mach...

Most physicians follow the joint commission?s guidelines on prescribing HTN medications which usually begin with a diuretic and calcium channel blocker (the amlodipine) - see below. Is it possible that your bp was still not controlled on the CCB (amlodipine)? So the ARB was added? Again, I?d just...

Plumbago et al, Thanks for letting me know about the "artan" drugs being ARBs. I think Cyclinglady was right the Losartan research is not free and thus not public. I saw the link with no abstract but wanted to read it to confirm as you noted in your ETA that it was another "Artan"...