Gastroenterology is a medical specialty that focuses on the diagnosis and treatment of diseases and disorders of the digestive system. The digestive system includes the organs involved in the digestion of food and absorption of nutrients, such as the mouth, esophagus, stomach, small intestine, and large intestine (colon).
That’s why New Day Diagnostics is constantly innovating and adding to our line of testing products:
While an infection can be treated with antibiotics, most cases go undiagnosed.
Our Biocard™ Helicobacter pylori IgG test offers high accuracy and easy detection in just 10 minutes using a single drop of blood. Importantly, antacid medication or antibiotics do not interfere with test results, so patient comfort can be maintained.
Celiac disease is a serious lifelong gastrointestinal disorder that can cause a wide spectrum of disruptive symptoms. However, 83% of celiac disease cases are undiagnosed.
Our proprietary Biocard™ Celiac Disease Self-Test uses a blood sample from a finger prick to identify the antibodies associated with celiac disease, allowing patients to mitigate symptoms by shifting to a gluten-free diet.
The Biocard™ or Helicobacter pylori Urease test is an easy tablet test for the rapid detection of the urease activity of biopsy and culture samples.
The tablet is added into water together with the biopsy or culture sample and a positive reaction can mostly be seen within 20-30 minutes. Sensitivity of 95% and specificity of 98.3% exceeds competitive offerings.
CE Mark for Professional use.
This item is currently not available for sale in the USA until FDA authorized. This page is made available for informational purposes only.
*PPA = positive percent agreement
**NPA = negative percent agreement
†Ct values = cycle threshold value. The higher the Ct, the more PCR cycles it took to identify the presence of the antigen. This means that a higher Ct indicates lower viral loads.
- 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.