New innovative product
to manage the Helicobacter Pylori infection
by DYONMED S.A.
One Step Point of Care Test
High reliability, immediate application, autonomy in diagnosis in the doctor’s office.
-
Indirect non-invasive method for the determination of Helicobacter pylori from a saliva sample through salivary urease detection.
-
99% reliability compared to Breath Test (UBT) through 14C determination
-
Only 1 to 2 hours of preparation before applying the Pylori Test®
INTERPRETATION OF THE RESULTS
POSITIVE: Two separate lines appear. One line should be in the control area (C) and the other line in the test area (T) indicating that the result is positive. Even if the line is faint, barely discernible, the result is evaluated as positive.
NEGATIVE:A line appears in the control area (C). No line appears in the test area (T).
INVALID: No lines are displayed or the control line (C) is not displayed, indicating user error or reagent failure. Verify the test procedure and repeat the test with a new device.
PERFORMANCE CHARACTERISTICS
Performance: The Pylori test® (H. pylori saliva) showed high sensitivity for H. pylori infection involving the stomach and oral cavity, compared to UBT 14C. In these conditions the performance of the Pylori test® device was:
Sensitivity and specificity
Specificity & Sensitivity of the Pylori test® device
-
-
- Positive Predictive Value: 98.17%.
- Negative Predictive Value: 100%.
- Accuracy overall: 99.15%.
-
Reliability-repeatability: Laboratory study shows that the sensitivity level of the Pylori test® is 5 ng/ml urease with a repetition of 50 repeated tests.
Contact us for further information.
Customer service call center +30 210 6655494
