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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.

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.

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4 Responses:

 
Jeff Kelly
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said this on
24 Oct 2010 7:59:19 PM PST
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
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said this on
03 Nov 2010 3:58:13 AM PST
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
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said this on
23 Oct 2011 7:12:09 PM PST
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
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said this on
29 Mar 2013 5:02:07 AM PST
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.




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