Transcript H. Pylori Infection

H. Pylori Infection
Taking H. pylori Diagnosis
to a painless & practical level
Ulcer Stimulants
H.pylori infection
Hyper acidity
Cigarette smoking
Alcohol
NSAIDs- antiinflammatories &
corticosteroids
H. pylori Causes Majority of Gastric Ulcers
50% of world population infected
with H. pylori by age 50.
 Organism present in up to:
• 92% active chronic gastritis
• 88-100% duodenal ulceration
• 58-100% gastric ulceration
• 46-94% gastric cancer
Helicobacter pylori (H. pylori)
Identified in 1982 as a
major cause of ulcers
A gram negative,
microaerophilic, curved
bacillus, residing in
human gastric mucosa.
Transmitted via oral route
When to Test for H.pylori ?
Patients with the following symptoms:
– Gastrointestinal pain
– Burning stomach pain
– Unexplained weight loss
– Nausea or vomiting
– Bloating
– Blood in vomit
– Dark red or black feces
The Importance of Early Detection
 Facilitate correct treatment for gastric ulcer
to improve living quality
 Eradication of H. pylori markedly reduces
duodenal ulcer disease recurrence rates
 Reduce gastric cancer rate
 Prevent H. pylori infection from spreading
Common Detection Methods
Test
Method
Sample
Preparation
Test Time
Lateral flow
rapid test
Serum,
plasma, whole
blood
None
15 minutes
ELISA test
Serum, plasma None
90 minutes
Antigen
test
Lateral flow
rapid test
Feces
Urea
breath
test
Scintillation
counts for
urease activity
Breath
Rapid
urease
test
Tissue urease
activity
Tissue biopsy
Culture
Culturing H.
Pylori
Tissue biopsy
Antibody
test
May avoid certain
medications
One month long
preparation
Drink radioactive
liquid
Fasting
Avoiding certain
medications
Fasting
Avoiding certain
medications
15 minutes
10 minutes
90 minutes
3 days
Invasive Detection Methods
Endoscopy
Visualization with camera to
observe lesions while under
sedation
Biopsy
Testing
Rapid Urease Test (RUT),
histology, culture,
takes hours or days for results
Urea Breath Test Detection
• Lengthy preparation process
• Consume radioactive liquid 15 mins prior to test
• Measures radiation count
• Not safe for children & pregnant women
OnSite H.pylori Antibody Detection
OnSite H. pylori Ab Rapid Test –Catalog: R0191C CE marked
Qualitatively detects antibodies (all isotypes-IgG, IgM and IgA) to H.pylori in:
•Serum
•Plasma
•Whole blood
OnSite H.pylori Ab Test Procedure
OnSite H. pylori Ab Rapid Test –Catalog: R0191C CE marked
1 drop of specimen
1 drop of sample diluent
Result
OnSite H.pylori Ab Test Result
Test Result Interpretation
Negative
No H.P Infection
Positive
Current or past infection
Invalid
Repeat test
OnSite H.pylori Antibody Test Performance
 Clinical study
OnSite H.P Ab Test
Reference
Positive
Negative
Total
Positive
138
4
142
Negative
0
182
182
Total
138
186
324
Relative sensitivity: 97.2%
Relative specificity: 100%
Overall agreement: 98.6%
 Reproducibility
100% in agreement with 20 duplicates of 95% above and 95%
below minimal detection level.
 Shelf life 18 months at 2-30 ℃
OnSite H.pylori Antibody Test Cross Reactivity
Disease stage
Sample size
OnSite H. Pylori Ab Combo
Rapid Test Result
HIV
10
100% negative
HCV
10
100% negative
HBV
10
100% negative
Syphilis
10
100% negative
HEV
10
100% negative
Jaundice
5
100% negative
Lipemic
5
100% negative
Hemolysis
5
100% negative
RF factor
5
100% negative
OnSite H.pylori Antibody Test
OnSite H. pylori Ab Rapid Test –Catalog: R0191C CE marked
Detects all isotype antibodies to H. Pylori in blood
 Very few rapid tests detect all of the antibody isotypes to
maximize detection sensitivity
Anti-H.Pylori antibody isotype profile





 IgG response: 95%
 IgA response: 68-80%
 IgM response: 14%.
Antibody test indicates for infection history, but not
active infection & is not useful in assessing eradication
No patient preparation required.
Serum & plasma specimens are easily accessible
No affect on children or pregnant woman
Low cost patient diagnosis
OnSite H.pylori Fecal Antigen Test
H.pylori replicate in the gastric track, producing proteins which are shed in the
gastro-intestinal lumen, and can easily be detected in feces.
Immediately indicates active infection
No need for special equipment
Relatively inexpensive
No special patient preparation
Suitable for use in pediatric patients
and pregnant woman
Post-treatment follow-up for patient
OnSite H.pylori Antigen Detection
OnSite H. pylori Ag Rapid Test –Catalog: R0192C CE marked
Qualitatively detects H.pylori Ag in feces
OnSite H.pylori Ag Test Procedure
OnSite H. pylori Ag Rapid Test –Catalog: R0192C CE marked
Pick up feces
Shake
Add to device
Results
OnSite H.pylori Ag Test Result
Test Result Interpretation
Negative
Positive
Invalid
No H.P Infection
Current infection
Repeat test
OnSite H.pylori Ag Test Performance
Clinical study
OnSite H.P Ag Test
UBT
Positive
Negative
Total
Positive
118
7
125
Negative
0
199
199
118
206
324
Total
Relative sensitivity: 94.4%
Relative specificity: 100%
Overall agreement: 98%
Reproducibility
100% in agreement with 20 duplicates of 95% above, 95%
below minimal detection level.
Shelf life
18 months at 2-30℃
OnSite H.pylori Ag Test Feature High Assay Specificity
The following microbes at >1x108 organism/ml had no impact on specificity
Adenovirus type II
Campylobacter coli
Campylobacter fetus
Campylobacter jejuni
Campylobacter lari
Candida albicans
Citrobacter freundii
Clostridium difficile
Clostridium perfringens
Enterococcus feacalis
Enterobacter cloacae
Escherichia coli
Escherichia fergusonii
Escherichia hermanii
Helicobacter cinaedi
Klebsiella pnumoniae
Mycobacterium smegmatis Providencia stuartii
Nocardia asteroids
Proteus vulgaris
Pseudomonas aeruginosa
Pseudomonas fluorescen Rotavirus
Salmonella(Group B)
Salmonella dublin
Salmonella hilversum
Salmonella typhimurium
Salmonella minnesota
Shigella boydii
Shigella dysenteriae
Shigella flexneri
Shigella sonne
Serratia liquefaciens
Staphylococcus aureus Staphylococcus aureus Staphylococcus faecalis
Staphylococcus galactiae Staphylococcus epidermidis Yersinia enterocolitica
OnSite H.pylori Ag Test Comparison
Competitor’s 98 specimen size
study using UBT test as reference*:
OnSite clinical study of 324
specimens using UBT test as
reference:
Relative sensitivity: 88%
Relative sensitivity: 94.4%
Relative specificity: 87.5%
Relative specificity: 100%
Overall agreement: 88%
Overall agreement: 98%
* Publication on Rapid test validation with feces 06/2010 on
http://www.scielo.br/scielo.php?script=sci_arttext&pid=S003646652010000300002&lng=en&nrm=iso&tlng=en
The OnSite Method Vs. Alternatives
Test Method
Sensitivity Specificity
%
%
Invasive Preparation
OnSite Ab
97.2%
100%
No
None needed
OnSite Ag
>95%
100%
No
Perhaps
Urea Breath Test
100%
>95%
No
4 weeks prior to testing
Biopsy-Histology
96.5%
98%
Yes
12 hours prior to testing
Biopsy -Rapid
Urease Test
93-97%
>95%
Yes
12 hours prior to testing
Biopsy-H. Pylori
Culture
70-80%
100%
Yes
12 hours prior to testing
3 days for results
OnSite: The practical advantages
OnSite Ab test
 Detects the most sensitive IgG
 Uses enriched H.pylori antigen
ensuring high sensitivity and
specificity
 Easy accessible specimens:
serum, plasma, whole blood,
suitable for all of the population
 Result in 15 minutes
 Highly accurate & reproducible:
97% sensitivity & 100%
specificity
 Ab Test control is available
OnSite Ag test
 Uses monoclonal antibody to
ensure high sensitivity
 Fecal specimen, non invasive,
suitable for all of the population
 Result in 15 minutes
 Highly accurate & reproducible:
95% sensitivity & 100% specificity
 Ag Test control is available
 Individual sample ID tag is
provided
 Used to follow up eradication
Key raw materials made in house to ensure
high quality, on time delivery, and the most competitive price
Final Message to Doctors
For primary screening to
check infection history
Order
Onsite H.pylori Ab test
R0190C
To diagnose active infection
& monitor the efficacy of
treatment
Order
Onsite H.pylori Ag test
R0191C
For further information about
OnSite H. Pylori tests
Local distributor
CTK contact information:
[email protected]
[email protected]
[email protected]
[email protected]
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San Diego, CA 92121, USA