Document No. : INS-HS-EN (Rev.

02)
Revision date : July 10, 2018

this ‘Instructions for use’.

 Use only fresh samples and avoid direct sunlight.
 There should be no contamination with urine or water in
samples.

H. pylori SA
 Lot numbers of all the test components (cartridge, ID chip,
detection buffer, and Extraction buffer tube) should agree.
 Do not interchange the test components between different
lots or use the test components after the expiration date,
either of which might yield misleading of test result(s).
INTENDED USE  Do not reuse. An extraction buffer tube should be used for
processing one sample only. So should a cartridge.
ichroma™ H. pylori SA(H. pylori Stool Antigen) is a fluorescence
 The cartridge should remain sealed in its original pouch before
Immunoassay (FIA) for the qualitative determination of H. pylori antigen
in human feces. It is useful as an aid in the diagnosis of H. pylori infection use. Do not use the cartridge, if is damaged or already opened.
and to demonstrate loss of H. pylori antigen following treatment.  Frozen sample should be thawed only once.
For in vitro diagnostic use only.  For shipping, samples must be packed in accordance with the
regulations.
INTRODUCTION  Just before use, allow the cartridge, extraction buffer tube
and sample to be at room temperature for approximately 30
Helicobacter pylori, previously Campylobacter pylori, is a gram-
minutes.
negative, microaerophilic bacterium found usually in the stomach.
 ichroma™ H. pylori SA as well as the instrument for ichroma™
It was present in a person with chronic gastritis and gastric ulcers
tests should be used away from vibration and/or magnetic
conditions. It is also linked to the development of duodenal ulcers
field. During normal usage, it can be noted that instrument for
and stomach cancer. More than 50% of the world's population
ichroma™ tests may produce minor vibration.
harbor H. pylori in their upper gastrointestinal tract. Individuals
 Used extraction buffer tubes, pipette tips and cartridges
infected with H. pylori have a 10 to 20% lifetime risk of developing
should be handled carefully and discarded by an appropriate
peptic ulcers and a 1 to 2% risk of acquiring stomach cancer.
method in accordance with relevant local regulations.
Several ways of testing H. pylori infection is exist. One can test
 An exposure to larger quantities of sodium azide may cause
noninvasively for H. pylori infection with a blood antibody test, stool
certain health issues like convulsions, low blood pressure and
antigen test, or with the carbon urea breath test.
heart rate, loss of consciousness, lung injury and respiratory
The ichroma™ H. pylori SA is an immunoassay for the detection
failure.
of H. pylori in stool sample.
- Use ichroma™ H. pylori SA should be used in conjunction
with the instrument for ichroma™ tests.
PRINCIPLE
The test uses a sandwich immunodetection method; the detector STORAGE AND STABILITY
antibody in buffer binds to antigen in sample, forming antigen-
 The cartridge is stable for 20 months (while sealed in an
antibody complexes, and migrates onto nitrocellulose matrix to be
aluminum foil pouch) if stored at 4-30 °C.
captured by the other immobilized-antibody on test strip.
 The detection buffer dispensed in a tube is stable for 20
The more antigen in sample forms the more antigen-antibody
months if stored at 4-30 °C.
complex and leads to stronger intensity of fluorescence signal on
 The extraction buffer dispensed in an extraction buffer tube is
detector antibody, which is processed by instrument for ichroma™
stable for 20 months if stored at 4-30 °C.
tests to show H. pylori antigen concentration in sample.
 After the cartridge pouch is opened, the test should be
performed immediately.
COMPONENTS
ichroma™ H. pylori SA consists of ‘Cartridges’, ‘Detection buffers’, LIMITATION OF THE TEST SYSTEM
‘Extraction buffers’, ‘ID chip’ and ‘Instruction for use’. The test may yield false positive result(s) due to the cross-
 The cartridge contains a test strip, the membrane which has reactions and/or non-specific adhesion of certain sample
anti-H.pylori IgG at the test line, while rabbit IgG at the control components to the capture/detector antigens.
line. The test may yield false negative result. The non-
 Each cartridge is individually sealed in an aluminum foil pouch responsiveness of the antibodies to the antigens is most
containing a desiccant. 25 sealed cartridges are packed in a common where the epitope is masked by some unknown
box which also contains an ID chip. components, so as not to be detected or captured by the
 The detection buffer contains anti-H.pylori IgG and anti-rabbit antibodies. The instability or degradation of the antigen with
IgG, which labeled with fluorescence dye. time and/or temperature may cause the false negative as it
 The detection buffer is dispensed in a tube. 25 detection makes antibody unrecognizable by the antigens.
buffer tubes are packed in the test cartridge box. Other factors may interfere with the test and cause erroneous
 The extraction buffer contains bovine serum albumin (BSA) as results, such as technical/procedural errors, degradation of
a stabilizer and sodium azide in Tris-Cl buffer as a preservative. the test components/reagents or presence of interfering
 The extraction buffer is dispensed in an extraction buffer tube. substances in the test samples.
25 extraction buffer tubes are packed in the test cartridge box. Any clinical diagnosis based on the test result must be
supported by a comprehensive judgment of the concerned
WARNINGS AND PRECAUTIONS physician including clinical symptoms and other relevant test
 For in vitro diagnostic use only. results.
 Carefully follow the instructions and procedures described in

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Document No. : INS-HS-EN (Rev. 02)
Revision date : July 10, 2018

MATERIALS SUPPLIED TEST PROCEDURE

REF CFPC-81
1) Collect sample according to the sample collection method
using a sampling stick in the ‘sample collection and
Components of ichroma™ H. pylori SA processing’.
- Cartridge 25 2) Cover the top of the extraction buffer tube with absorbent
- Extraction buffer 25 paper to avoid splatter
- Detection buffer 25 3) Break off the black tip on the outside of the black cap.
- ID chip 1 4) Discard 3 drops of reagent onto the paper towel before
- Instruction for Use 1 applying the sample to the cartridge.
5) Hold the vial upside down and transfer 4 drops of sample to
MATERIALS REQUIRED BUT SUPPLIED ON DEMAND a detection buffer tube containing granule.
Following items can be purchased separately from ichroma™ H. pylori 6) Pipette out 75 μL of a sample mixture and load it into the
SA. Please contact our sales division for more information. sample well on the cartridge.
Instrument for ichroma™ tests 7) Leave the sample-loaded test cartridge for 12 minutes.
- ichroma™ Reader REF FR203 Scan the sample-loaded cartridge immediately when the
incubation time is over. If not, it will cause inexact test result.
- ichroma™ II REF FPRR021
8) To scan the sample-loaded cartridge, insert it into the
cartridge holder of the instrument for ichroma™ tests.
SAMPLE COLLECTION AND PROCESSING
Ensure proper orientation of the cartridge before pushing it
The sample type for ichroma™ H. pylori SA is human feces. all the way inside the cartridge holder.
Invert an extraction buffer and loosen the cap which is attached a 9) Press ‘Select’ button on the instrument for ichroma™ tests
sampling stick (yellow color). to start the scanning process.
Introduce the sampling stick into the fecal sample five times at 10) Instrument for ichroma™ tests will start scanning the
different sites. In order to get sampling even in the spirals of the sample-loaded cartridge immediately.
stick and to ensure appropriate specimen to buffer ratio, try to 11) Read the test result on the display screen of the instrument
avoid obtaining clumps of fecal matter. for ichroma™ tests.

INTERPRETATION OF TEST RESULT

 Instrument for ichroma™ tests calculates the test result
automatically and displays “Positive/Negative”
 Ancillary value is served in the form of a cut-off index (COI)
Cut-off index (COI) Result
Return the stick to the extraction buffer. Tighten the cap <1 Negative for H. pylori
thoroughly and shake the tube vigorously so as to disperse the ≥1 Positive for H. pylori
specimen throughout the extraction buffer in the tube  Samples are considered equivocal and must be repeated if
If not to be used immediately after addition of fecal sample, their COI is within the range 0.1 units above the cut-off.
extraction buffer should be refrigerated but must be analyzed using
the test cartridge within 12 hours. QUALITY CONTROL
The collected specimen should be tested as soon as possible, but
may be held up to 24 hours at 2-8 °C prior to testing. If testing will Quality control tests are a part of the good testing practice to
be delayed more than this time frame, samples should be frozen at confirm the expected results and validity of the assay and
-20 °C. should be performed at regular intervals.
Samples stored frozen at -20 °C for 2 months showed no The control tests should be performed immediately after
performance difference.
opening a new test lot to ensure the test performance is not
Repeated freezing and thawing can result in the change of test
altered.
values.
Quality control tests should also be performed whenever
there is any question concerning the validity of the test results.
TEST SETUP Control materials are not provided with ichroma™ H. pylori SA.
 Check the contents of ichroma™ H. pylori SA: Sealed Cartridges, For more information regarding obtaining the control
Extraction Buffers, Detection buffers, and an ID Chip. materials, contact Boditech Med Inc.’s Sales Division for
 Ensure that the lot number of the cartridge matches that of the ID assistance.
chip as well as the other contents. (Please refer to the instruction for use of control material.)
 Keep the sealed cartridge and the extraction buffer (if stored in
refrigerator) at room temperature for at least 30 minutes just prior PERFORMANCE CHARACTERISTICS
to the test. Place the cartridge on a clean, dust-free and flat surface.
 Turn on the instrument for ichroma™ tests.  Sensitivity
 Insert the ID Chip into the ID chip port of the instrument for Detection limit: a culture of H. pylori were sonicated, and its
ichroma™ tests. concentration was determined. The detection limit of H. pylori
 Press the ‘Select’ button on the instrument for ichroma™ tests. is 3 ng/ml.
(Please refer to the ‘Instrument for ichroma™ tests Operation
Manual’ for complete information and operating instructions.)  Specificity
There was no significant interference on results when present
in stool with Tagamet® (5mg/ml), Tums® antacid (5mg/ml),
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Document No. : INS-HS-EN (Rev. 02)
Revision date : July 10, 2018

Prilosec® (5mg/ml), Mylanta® Antacid (1:20), Pepto-Bismol For technical assistance; please contact:
(1:20), Barium sulfate (5%), Whole Blood (50%). Leukocytes Boditech Med Inc.’s Technical Services
(50%), Mucin (3.4%), Stearic acid/palmitic acid (Fecal fat) (4%), Tel: +82 33 243-1400
Hemoglobin (tarry stool) (12.5%). Also there was no significant E-mail: [email protected]
cross-reactivity with Enterobacter cloacae, Candida albicans,
Escherichia coli, Pseudomonas aeruginosa, Bacillus
subtilis.spizizenii, Clostridium sporogenes, H. influenzae, Boditech Med Incorporated
Campylobacter jejuni, Borrelia burgdorferi, Proteus morgani. 43, Geodudanji 1-gil, Dongnae-myeon,
Chuncheon-si, Gang-won-do, 24398
 Comparability with reference product Republic of Korea
Reference ELISA result Tel: +(82) -33-243-1400
Positive Negative Total Fax: +(82) -33-243-9373
Positive 102 1 103 www.boditech.co.kr
ichroma™
Negative 3 54 57
H. pylori SA
Total 105 55 160 Obelis s.a
- Percent positive agreement = 97.1% Bd. Général Wahis 53,
- Percent negative agreement = 98.2% 1030 Brussels, BELGIUM
- Overall percent agreement = 97.5% Tel: +(32) -2-732-59-54
Fax: +(32) -2-732-60-03
REFERENCES E-Mail: [email protected]
1. Chang, A. H. and Parsonnet, J. Role of Bacteria in Oncogenesis.
Clinical Microbiology Reviews. 2010; 23 (4): 837–857.
2. Amieva, Manuel and Peek, Richard M. Pathobiology of
Helicobacter pylori–Induced Gastric Cancer. Gastroenterology.
2016; 150 (1): 64–78.
3. Blaser MJ Who are we? Indigenous microbes and the ecology
of human diseases. EMBO Reports. 2006; 7 (10): 956–60
4. Stenström B, Mendis A, Marshall B. Helicobacter pylori—The
latest in diagnosis and treatment. Aust Fam Physician. 2008;
37 (8): 608–12.

Note: Please refer to the table below to identify various symbols.

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