4
High Infection Rates in the Population
References:
(1) Cardenas VM et al., Am J Epidemiol 2006; 163 :
127–134. (2) Lahner E et al., Helicobacter 2012; 17:
1–15. (3) Suzuki, T., et al.: Am. J. Gastroenterol. 2005,
100, 1265. (4) Yeh J-J et al., Blood 2010; 115(21):
4247–4253. (5) Vergara M et al., 2005; Aliment Phar-
macolt Ther; 21: 1411–1418. (6) Malfertheiner P et
al., Gut 2012; 61: 646–664. (7) Gatta L et al., Aliment
Pharmacol Ther 2003; 17: 793–798. (8) Wong WM
et al., Aliment Pharmacol Ther 2003; 17: 253–257.
* Source: Kibion Symposium: “Helicobacter pylori
UBT and other diagnostic breath tests“, 23. October
2012, Amsterdam
Significant correlation
Further studies at the MVZ Dr. Eber-
hard & Partner, in Dortmund, Ger-
many, evaluated Diabact
®
UBT in
conjunction with an IRIS
®
instru-
ment (Infra Red Isotope Analyser) for
breath test analysis and compared it
with Finnigan BreathMAT
®
Plus MS
analyser (see figure and table above).
The aim of the study was to evaluate
breath test methods that gave test-
ing laboratories and sample dispatch-
ers the highest efficiency.
The evaluation of a total of 184 Di-
abact
®
UBT breath samples dem-
onstrated excellent correlation be-
tween mass spectrometry and infra
red isotope spectrometry. This study
validates the use of IRIS
®
in combina-
tion with Diabact
®
UBT as an alter-
native to mass spectroscopy for the
diagnosis of H. pylori.
Results generated by both methods
– MS and IRIS
®
– correlated well. The
highest values were obtained when
comparing the averages (
г
= 0.989
and sensitivity = 85, specificity = 97
for MS vs. IRIS
®
).
The discrepancy between the two
methods was only observed in a
very few samples (6 of 161 of the
averages).
The authors conclude that H. pylori
diagnosis with Diabact
®
UBT and
analysis by mass spectrometry after
10 minutes gave satisfactory results
with a cut-off of 1.5‰. Moreover,
diagnostic results obtained using
Diabact
®
UBT and IRIS
®
are statisti-
cally, significantly correlated to re-
sults obtained with mass spectrosco-
py. IRIS
®
and Diabact
®
UBT therefore
present a valid test alternative to MS
for the diagnosis of H. pylori.
ing, both values for the 50mg tablet
were 100%. The authors emphasize
that the tablet test is reliable before
and after treatment.
A further study
8
investigated the test
accuracy of the 50mg tablet. Dys-
peptic patients underwent endos-
copy and then were checked and
compared with the Diabact
®
UBT or
the gold standard rapid urease test
and histology. Breath samples were
taken at 0, 10, 20 and 30 minutes.
The sensitivity and specificity of
the Diabact
®
UBT (50mg) was 100
and 98% after 10 minutes, 100 and
100% after 20 minutes and 100 and
98% after 30 minutes.
0
0
5
10
15
20
25
30
35
40
45
y=0.9941x + 0.082
R²=0,99
n=158
10
20
Average IRIS
®
30
40
50
Average MS
Send sample to test lab
Breathe into base
line tubes
A
Swallow Diabact
®
UBT
tablet with a little water
H
2
O +
B
After 10-minutes, breathe
into sample tubes
C
D
Reference range Diabact
®
Negative
Positive
IRIS-3
<1.3‰
i
d
-Value
>1.7‰
i
d
-Value
Mass spectroscopy
<1.5‰
i
d
-Value
>1.5‰
i
d
-Value
1,2,3 5,6,7,8