 |
Clinical Evaluation |
|
| |
| |
Endoscopic |
Serology |
Liquid
UBTS |
HelicapTM |
| Patient Comfort
and Convenience |
+ |
++ |
++ |
+++ |
| Time |
+ |
+++ |
+ |
+++ |
| Preparation |
+ |
++ |
++ |
+++ |
| Cost |
+ |
+++ |
++ |
+++ |
| Sensitivity and
Specificity |
+++ |
+ |
++ |
+++ |
|
Comparing the benefits: Heliprobe™ is superior to other
diagnostic methods for detection of Helicobacter pylori infection. |
 |
|
|
| Golden Standard |
| Urea breath testing (UBT) is currently
considered to be the golden standard for non-invasive diagnosis
of Helicobacter pylori infection. It is highly reliable for
pre- and post-treatment follow-up of infection. However, tests
in liquid form have several disadvantages compared to HeliCap™
solid-capsule formulation. |
| |
| To ensure equivalent results comparable
with sophisticated, well-established laboratory techniques
used for scientific purposes, the following comparison
between Heliprobe™ and liquid scintillation for
14C detection was made. A laboratory set-up (simulating
the patient) with controlled parameters according to figure
1 was established. |
|
|
| |
| The result of the comparison was statistically
analyzed applying linear regression. The outcome of the analysis
shows a regression line with high correlation between these
methods as presented in figure 2. |
|
| Clinical Validation studies involving
more than 400 patients has also been performed at the Karolinska
University Hospital in Stockholm, Sweden1. |
Heliprobe™ System has
been compared to other UBTs.
The conclusions from the clinical evaluations were:
|
| • |
The HeliCap™
capsule minimizes false positive results by eliminating
urea hydrolysis in the |
| |
mouth and on the way to
the stomach. |
| • |
The solid capsule eliminates
the need for a pre-test meal. |
| • |
Short time to sampling,
only 10 minutes after capsule intake. |
| • |
Results obtained on site,
within 5 minutes after sampling. |
| • |
Acid supplementation in
the capsule reduces the risk of false negative results. |
| • |
Sensitivity and specificity
are 95% and 100%. |
|
| |
| In conclusion, the Heliprobe™
system in comparison with liquid-based urea breath tests is
more accurate, rapid and easy to use. The simplicity and handiness
of the system makes it ideal for detection of Helicobacter pylori
directly in the doctor’s office. |
| |
|
| |
|
Research Papers |
 |
|
| Click
here to view html files |
| |
|
top
|
