Get celiac disease answers.
Then start getting relief.
Our test is highly accurate and will enable you to determine if you have celiac disease, which is caused by gluten intolerance or gluten sensitivity and need to adjust your diet and lifestyle.
Celiac disease is a serious, lifelong, gastrointestinal disorder that can cause a wide spectrum of symptoms, including weight loss, abdominal distention, diarrhea, malnutrition and skin disorders. It is estimated that over 80% of people are either undiagnosed or misdiagnosed.
A Patented Immune-Chromatographic Rapid Test for Antibodies
- CE marked for home and professional Use
- Highly accurate; 96.7% sensitivity, 93.5% specificity
- Results in just 10 minutes
- Easy to use, requiring only 1 droplet of blood
- Each kit contains all the materials needed to test
Easy To Use
Biocard™ Celiac Rapid Test showed 96.7% sensitivity and 93.5% specificity,
and it can be performed in approximately 10 minutes.
The test result is positive if a red line appears in the control field (C) and in the test field (T). The test line can be strong or weak.
The test result is negative if a red line appears in the control field (C) and no red line forms in the test field (T).
If no control line forms, you have likely not followed the instruction for use
or test unit is damaged. Should this occur, repeat the test with a new test unit.
CE approval for sale in Europe.
Premarket 510(k) submission to FDA for clearance in the U.S.
Please note: Product Specifications are subject to change without prior notice and may include product modifications, improvements or upgrades.
Please check with New Day Diagnostics or your sales rep.
- This product has been authorized by the FDA under an Emergency Use Authoization (EUA)
- This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.
- The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.