Innovative Global Leader of Vitro Diagnostics Standard Diagnostics, Inc.

H. pylori Ag Rapid test H. pylori Ag ELISA Non-invasive diagnosis of H. pylori infection using stool

H. pylori Ag A rapid, qualitative test for the detection of Helicobacter pylori antigen in human fecal specimens. Easy to use : No need of any equipment Fast test result : 10-15 minutes Specimen : Stool Sensitivity : 100% / Specificity : 100%

Usefulness of Stool Antigen Test Suitable for mass screening test

Best primary care

Indicator of active H. pylori infection

Facilitate anti-H.pylori therapy

Post-treatment follow-up for patient

H.pylori Ag rapid test (Stool antigen test)

Urea Breath Test (UBT)

Effectively indicates active infection Rapid test result available Comfort to patient No need of any special equipment Relatively inexpensive Appropriate for use in pediatric patients

Highly sensitive and specific Requires ingestion of isotopically-labeled urea as well as specialized instrumentation for the detection 14C and 13C Risk and discomfort to children and pregnant women

Test Procedure 2

Interpretation of the test

up to the fill line

Negative H. pylori Ag H. pylori Ag

1

Transfer assay diluent into sample collection tube twice.

2

Take a portion of feces (about 50mg) from a stool sample with the sample collection swab.

3

Insert the swab into the sample collection tube and swirl the swab at least 10 times.

10' ~ 15'

3 drops H. pylori Ag H. pylori Ag

4

Discard the swab while squeezing the swab against the wall of tube.

5

Assemble dropping cap on the sample collection tube.

H. pylori Ag H. pylori Ag

Invalid H. pylori Ag H. pylori Ag

H. pylori Ag H. pylori Ag

6

Positive

Add 3 drops into the sample well (S) of test device.

Interpret test results at 10~15 minutes.

H. pylori Ag H. pylori Ag

Ordering Information Product

Cat. No.

Description

Type

Test/Kit

Specimen

Storage

H.pylori Ag

04FK20

One step H.pylori Antigen test

Device

20Tests/Kit

Stool

24M / 1~30 C

H.pylori

04FK10

One step H.pylori Antibody test

Device

30Tests/Kit

S/P

24M / 2~30 C

H.pylori

04FK11

One step H.pylori Antibody test

Multi Device 100Tests/Kit

S/P

24M / 2~30 C

H. pylori Ag ELISA An enzyme-linked immunosorbent assay for the qualitative detection of Helicobacter pylori antigen in human fecal specimens Storage : 2-8 C for 12 months Specimen: stool Sensitivity: 100% / Specificity: 100% Simple assay procedure Short assay time: 60min+10min (70min)

Optimal indicator to confirm treatment efficacy Accurate method to confirm the successful eradication With successful eradication, SD H. pylori Ag ELISA become negative immediately after the end of therapy. According to internal evaluation, SD H. pylori Ag ELISA shows 100% correlation with successful eradication. (Pre-treatment : all positive, Post-treatment : all negative)

Test Procedure [Sample predilution]

1. Transfer 1 ml of sample diluent to a clean test tube.

2. Take a portion of feces (about 50mg) from a stool sample.

3. Insert the swab into the sample collection tube and swirl the swab at least 10 times.

4. Discard the swab while squeezing the swab against the wall of tube.

5. Leave the tube alone for 5~10 minutes and use the upper layer except large particles.

[Assay plate] Patient's H.pylori antigen

3. Wash the wells 5 times with 350µl of diluted washing Solution. Pipette 100µl mixed TMB solution into each well.

Anti-H.pylori

1. Pipette 100µl of Controls and prediluted patient's samples into microplate wells.

2. Add 25µl of Enzyme conjugate to each well. Then Incubate at 37 ±1 C for 60 minutes

4. Incubate for 10 minutes at room temperature (15~30 C) in the dark (covered). 5. Stop the reaction with 100µl of Stopping Solution and read absorbance of each well at 450nm within 30minutes.

Ordering Information Product

Cat. No.

Type

Test/Kit

Specimen

Storage

H. pylori Ag ELISA

04EK20

Microplate

96wells/Kit

Stool

12M / 2~8 C

Helicobacter pylori H. pylori infection is the principal cause of chronic active gastritis and peptic ulcer disease and a major contributor for gastric adenocarcinoma and mucosa-associated lymphoid tissue lymphoma

Diagnosis of H. pylori infection

Test

Non-Invasive

Rapid urease test Histology Culture

Stool antigen test Urea breath test(UBT) Serologic tests(ELISA)

Features

Invasive

Gold standard Requires endoscopy May cause complication Equipment needed

High sensitivity & specificity Cost: Affordable(relatively inexpensive) Comfort to patient Medication(PPI, Bismuth) affect the result

Non-invasive tests are useful for primary diagnosis, when a treatment indication already exists, or to monitor treatment success or failure.

The AGA(American Gastroenterological Association) recommends that: Dyspepsia without GERD or NSAIDs Age > 55 or alarm symptoms present

_ 55 No alarm symptoms Age < Test for H.pylori

EGD

Negative

PPI trial 4-6 weeks

Positive

Treat for H.pylori

Gastroesophageal reflux disease (GERD) Nonsteroidal Antiinflammatory Drugs (NSAIDS)

Alarm symptoms: Weight loss, progressive dysphagia, recurrent vomiting, evidence of gastrointestinal bleeding, or family history of cancer



65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of Korea Tel : +82-31-899-2800 Fax : +82-31-899-2840 E-mail : [email protected]

LEF04EN Rev.1406-00

" Patients 55 years of age or younger without alarm features should receive H.pylori test and treat followed by acid suppression if symptoms remain."