H. Pylori Infection Taking H. pylori Diagnosis to a painless & practical level.
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H. Pylori Infection Taking H. pylori Diagnosis to a painless & practical level
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Transcript of H. Pylori Infection Taking H. pylori Diagnosis to a painless & practical level.
H. Pylori Infection
Taking H. pylori Diagnosisto a painless & practical level
Ulcer Stimulants
H.pylori infectionHyper acidityCigarette smokingAlcoholNSAIDs- anti-
inflammatories & 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
Identified in 1982 as a major cause of ulcers
A gram negative, microaerophilic, curved bacillus, residing in human gastric mucosa.
Transmitted via oral route
Helicobacter pylori (H. pylori)
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 MethodsTest Method Sample Preparation Test Time
Antibody test
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 May avoid certain
medications 15 minutes
Urea breath test
Scintillation counts for urease activity
Breath
One month long preparation Drink radioactive liquid
10 minutes
Rapid urease test
Tissue urease activity Tissue biopsy
FastingAvoiding certain medications
90 minutes
Culture Culturing H. Pylori Tissue biopsy
FastingAvoiding certain medications
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
1 drop of specimen 1 drop of sample diluent Result
OnSite H. pylori Ab Rapid Test –Catalog: R0191C CE marked
OnSite H.pylori Ab Test Result
Test Result Interpretation
Negative Positive Invalid
No H.P Infection Current or past infection Repeat test
OnSite H.pylori Antibody Test Performance
Clinical study
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.P Ab Test Reference Positive Negative Total Positive 138 4 142Negative 0 182 182
Total 138 186 324
Relative sensitivity: 97.2%
Relative specificity: 100%
Overall agreement: 98.6%
OnSite H.pylori Antibody Test Cross Reactivity
Disease stage Sample size OnSite H. Pylori Ab Combo
Rapid Test ResultHIV 10 100% negative
HCV 10 100% negativeHBV 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
Anti-H.Pylori antibody isotype profile IgG response: 95% IgA response: 68-80% IgM response: 14%.
Very few rapid tests detect all of the antibody isotypes to maximize detection sensitivity
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
Immediately indicates active infectionNo need for special equipmentRelatively inexpensive
No special patient preparationSuitable for use in pediatric patients and pregnant womanPost-treatment follow-up for patient
H.pylori replicate in the gastric track, producing proteins which are shed in the gastro-intestinal lumen, and can easily be detected in feces.
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 ResultTest Result Interpretation
Negative Positive Invalid
No H.P Infection Current infection Repeat test
OnSite H.pylori Ag Test Performance
Clinical study
Reproducibility 100% in agreement with 20 duplicates of 95% above, 95%
below minimal detection level.
Shelf life 18 months at 2-30℃
OnSite H.P Ag Test UBT Positive Negative Total Positive 118 7 125Negative 0 199 199Total 118 206 324
Relative sensitivity: 94.4%
Relative specificity: 100%
Overall agreement: 98%
OnSite H.pylori Ag Test Feature High Assay Specificity
The following microbes at >1x108 organism/ml had no impact on specificityAdenovirus type II Campylobacter coli Campylobacter fetus Campylobacter jejuni Campylobacter lari Candida albicansCitrobacter freundii Clostridium difficile Clostridium perfringensEnterococcus feacalis Enterobacter cloacae Escherichia coliEscherichia fergusonii Escherichia hermanii Helicobacter cinaedi Klebsiella pnumoniae Mycobacterium smegmatis Providencia stuartiiNocardia asteroids Proteus vulgaris Pseudomonas aeruginosa
Pseudomonas fluorescen Rotavirus Salmonella(Group B)Salmonella dublin Salmonella hilversum Salmonella typhimurium
Salmonella minnesota Shigella boydii Shigella dysenteriaeShigella flexneri Shigella sonne Serratia liquefaciens Staphylococcus aureus Staphylococcus aureus Staphylococcus
faecalisStaphylococcus galactiae Staphylococcus epidermidis Yersinia
enterocolitica
OnSite H.pylori Ag Test Comparison
Competitor’s 98 specimen size study using UBT test as reference*:
Relative sensitivity: 88%
Relative specificity: 87.5%
Overall agreement: 88%
* 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
OnSite clinical study of 324 specimens using UBT test as reference:
Relative sensitivity: 94.4%
Relative specificity: 100%
Overall agreement: 98%
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 testing3 days for results
The OnSite Method Vs. Alternatives
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
treatmentOrder
Onsite H.pylori Ag test R0191C
For further information about OnSite H. Pylori tests
Local distributor
[email protected] [email protected]@[email protected]@[email protected] San Diego, CA 92121, USA
CTK contact information:
