FAQs

 

  • No, that’s the beauty of Pylori DuoTect®! It can be performed anywhere, anytime. It is a flexible tool that is not bound to any specific machine and does not require further equipment. The results are read visually. The only materials that are needed and not supplied with the kit are:
    – Lancet
    – Alcohol swab
    – Timer

  • The Pylori DuoTect® H. pylori Rapid Test is designed for use in first-line diagnostics. With a result after 20 minutes, clinical staff at the point-of-care can decide whether to perform further diagnostic tests (e.g. Urea Breath Test) or to proceed directly to treatment. A decisive advantage over other methods is the direct testing of the patient, on the spot. There is no need for patients to prepare weeks in advance (i.e., discontinuing PPIs and antibiotics, which can take between 10 and 30 days).

    However, the results must always be interpreted in relation to the clinical picture and other diagnostic procedures.

  • The Pylori DuoTect® H. pylori Rapid Test is an antibody test and does not distinguish between an active and a past infection. However, it provides two strong indicators for an H. pylori infection and additional patient information, such as CagA risk stratification.

  • No, Pylori DuoTect® is not a tumor marker, but the appearance of CagA indicates an additional risk factor. Studies show a significant correlation between CagA and peptic ulcers, as well as stomach cancer.

  • The test is intended to be used in adult subjects only. One of the reasons is that H. pylori infection is mainly acquired in childhood and most children with H. pylori infection are asymptomatic; only a very small number develop peptic ulcer disease. Since testing for H. pylori in children is therefore uncommon and the antigen stool test is the method of choice, ImevaX has decided to design the test for adults only.

  • Yes, even a faint FliD and/or CagA line indicates a positive result. Even a faint control line (C) indicates that the test was performed properly.

  • No, the intensity of the FliD and CagA lines does not correspond to the titer or severity of the infection.

  • The performance study confirmed a sensitivity of >98%, specificity of >91% and overall accuracy of >93%.