H. Pylori Infection Taking H. pylori Diagnosis to a painless & practical level

Ulcer Stimulants  H.pylori infection  Hyper acidity  Cigarette smoking  Alcohol  NSAIDs- 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 % duodenal ulceration % 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 Methods TestMethodSamplePreparationTest Time Antibody test Lateral flow rapid test Serum, plasma, whole blood None15 minutes ELISA testSerum, plasmaNone90 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 Fasting Avoiding certain medications 90 minutes Culture Culturing H. Pylori Tissue biopsy Fasting Avoiding 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 NegativePositiveInvalid 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 ReferencePositiveNegativeTotal Positive Negative0182 Total Relative sensitivity: 97.2% Relative specificity: 100% Overall agreement: 98.6%

OnSite H.pylori Antibody Test Cross Reactivity Disease stageSample size OnSite H. Pylori Ab Combo Rapid Test Result HIV10100% negative HCV10100% negative HBV10100% negative Syphilis10100% negative HEV10100% negative Jaundice5100% negative Lipemic5100% negative Hemolysis5100% negative RF factor5100% 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 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 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 Result Test Result Interpretation NegativePositiveInvalid 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 life18 months at 2-30 ℃ OnSite H.P Ag Test UBTPositiveNegativeTotal Positive Negative0199 Total Relative sensitivity: 94.4% Relative specificity: 100% Overall agreement: 98%

OnSite H.pylori Ag Test Feature High Assay Specificity The following microbes at >1x10 8 organism/ml had no impact on specificity Adenovirus type IICampylobacter coliCampylobacter fetus Campylobacter jejuniCampylobacter lariCandida albicans Citrobacter freundiiClostridium difficileClostridium perfringens Enterococcus feacalisEnterobacter cloacaeEscherichia coli Escherichia fergusoniiEscherichia hermaniiHelicobacter cinaedi Klebsiella pnumoniae Mycobacterium smegmatis Providencia stuartii Nocardia asteroidsProteus vulgaris Pseudomonas aeruginosa Pseudomonas fluorescenRotavirusSalmonella(Group B) Salmonella dublin Salmonella hilversumSalmonella typhimurium Salmonella minnesota Shigella boydiiShigella dysenteriae Shigella flexneriShigella sonneSerratia liquefaciens Staphylococcus aureusStaphylococcus 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*: Relative sensitivity: 88% Relative specificity: 87.5% Overall agreement: 88% * Publication on Rapid test validation with feces 06/2010 on OnSite clinical study of 324 specimens using UBT test as reference: Relative sensitivity: 94.4% Relative specificity: 100% Overall agreement: 98%

Test MethodSensitivity % Specificity % InvasivePreparation OnSite Ab97.2%100%NoNone needed OnSite Ag>95%100%NoPerhaps Urea Breath Test100%>95%No4 weeks prior to testing Biopsy-Histology96.5%98%Yes12 hours prior to testing Biopsy -Rapid Urease Test 93-97%>95%Yes12 hours prior to testing Biopsy-H. Pylori Culture 70-80%100%Yes12 hours prior to testing 3 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 treatment Order Onsite H.pylori Ag test R0191C

For further information about OnSite H. Pylori tests Local distributor San Diego, CA 92121, USA CTK contact information: