EpiTuub
Fecal H. pylori Antigen Rapid Test Kit - Instructions for Test Procedures
Qualitative detection of H. pylori antigen in human feces.
Manufactured by Epitope Diagnostics, Inc. San Diego CA 92121, USA pAGE 3
(V6/2019-08) Page 3 PAGE 3 pPage 3 US Patent: 7,780,915
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LIMITATION OF THE PROCEDURE
1. The test should be used only for the detection of H. pylori
antigen in fecal samples.
2. The test is qualitative, and no quantitative interpretation
should be made with respect to the intensity of the positive line,
when reporting the result.
3. Two hundred samples were evaluated to assure the correct
performance of the test. The correlation of the results with other
techniques (ELISA) was satisfactory. However, interferences in
the performance of the tests should not be excluded.
4. As with all diagnostic tests, the definitive clinical diagnosis
must not be based on the result of a single test, but should only
be made by the physician after all clinical and laboratory
findings have been evaluated. EpiTuub
TM
Fecal H. pylori
antigen test is designed for the aid of clinical diagnosis and
should not replace other diagnostic procedures.
PERFORMANCE CHARACTERISTICS
Sensitivity
Detection limit: A culture of H. pylori bacteria was sonicated,
centrifuged and its protein concentration was determined. This
reference antigen preparation of H. pylori was diluted in 0.01M
PBS-BSA buffer and tested with this kit according to the above
described test procedures. The detection limit of H. pylori is
about 4 – 8 ng/ml.
Specificity
The evaluation was performed by comparison this rapid test
with an commercial H. pylori antigen ELISA kit. The detection of
H. pylori showed 95% of concordance with the ELISA.
The monoclonal antibody used in this rapid test regognises
epitopes present in the antigen found in stool of patients, as
well as in preparations from the bacteria cultures in vitro.
Sonicated H. pylori extract from different commercial samples
reacts with this H. pylori antigen rapid test.
The possibility for interference of human anti-mouse antibodies
(HAMA) or high levels of rF in the stool sample have not been
evaluated.
REFERENCES
1. Yang HR, Seo JK. Helicobacter pylori Stool Antigen (HpSA) Tests in Children Before and
After Eradication Therapy: Comparison of Rapid Immunochromatographic Assay and HpSA
ELISA. Dig Dis Sci. 2007 Dec 13;
2. Wu DC, Wu IC, Wang SW, Lu CY, Ke HL, Yuan SS, Wang YY, Chang WH, Wang TE, Bair
MJ, Kuo FC. Comparison of stool enzyme immunoassay and immunochromatographic method
for detecting Helicobacter pylori antigens before and after eradication. Diagn Microbiol Infect
Dis. 2006 Dec;56(4):373-8.
3. Kato S, Ozawa K, Okuda M, Fujisawa T, Kagimoto S, Konno M, Maisawa S, Iinuma K.
Accuracy of the stool antigen test for the diagnosis of childhood Helicobacter pylori infection: a
multicenter Japanese study. Am J Gastroenterol. 2003 Feb;98(2):296-300.
2. Test strip tube (30197): one dipstick for the H. pylori test is
assembled in a transparent housing and sealed in a foil
pouch with desiccant. It should remain in its original sealed
pouch until ready for use. The test strip should be stored
at 2 to 8ºC. Do not freeze.
3. Instruction for use.
MATERIALS REQUIRED BUT NOT SUPPLIED
1. Timer or clock
PRECAUTIONS
1. For in-vitro diagnostic use only. Not to be taken internally.
2. Do not use product beyond the expiration date.
3. Handle all specimens as potentially infectious.
4. Do not reuse the test.
PATIENT PREPARATION
1. Dietary restrictions are not necessary.
SPECIMEN COLLECTION
1. Stool specimens can be collected at any time of the day.
2. Collect a random sample of feces in a clean, dry cup or
toilet paper or as indicated in the Figure 1.
3. Unscrew the sampling lid and keep the sampling tube in a
vertical position to prevent the loss of any extraction
solution.
4. Insert and twist the tip of the sampling lid into the stool
specimen at two or more different sites (Figure 2).
5. Collect fecal sample that is stuck to the surface of the
sampling lid. The total amount of stool sample should be
less than one grain of cooked rice. Do not intentionally
collect any separate and large pieces of fecal sample into
the tube.
6. Replace the sampling lid into the tube and secure tightly
(Figure 3).
7. The specimen is ready for testing, transportation or
storage. It can be stored at 2-8ºC for up to 21 days and at
room temperature for up to 14 days.
TEST PROCEDURE
1. Bring the sealed foil pouch test strips and collected
specimens to room temperature.
2. Shake the sampling tube vigorously to ensure a good liquid
suspension.
3. Position the sampling tube upside down vertically and let it
settle for about 1 minute.
4. Remove the test strip from the sealed foil pouch.
5. Screw the test strip tube into the sampling tube by breaking the
bottom seal of the sampling tube. Secure tightly! (Figure A)
6. Allow the solution to flow into the bottom space of the test strip
and keeping the device in a vertical position.
7. Read test result at 5 minutes. Do not interpret test result after 10
minutes.
PROCEDURAL NOTES
1. After the test strip tube is screwed completely into the sampling
tube, you should see a minimum 5 mm extraction buffer liquid in
the bottom of the strip tube.
2. You should see liquid migrating across the membrane area
right after the screw in process. If not, take the tube and tap
against the table several times, and the migration of the liquid
should be observed.
INTERPRETATION OF RESULTS
Positive:
If two red/pink colored bands are visible within 5 minutes, the
test result is positive and valid (Figure B).
Negative:
If test area has no red/pink colored band and the control area
displays a red/pink colored band, the test result is negative
(Figure B).
Invalid:
If a colored band does not form in the control area regardless of
there being any band in the test area, the test result is invalid
(Figure B) and needs to be retested.
QUALITY CONTROL
Good laboratory practices recommend the use of appropriate
controls. There are two types of controls for the EpiTuub®
H.pylori
test, the internal procedural control and external controls.
1. Internal procedural control: Each EpiTuub® H. pylori test has
a built-in procedural control. It will appear if the test has been
performed correctly, sample wicking has occurred and the
reagents are reactive. It does not ensure that the test line
antibody is accurately detecting the presence or absence of H.
pylori in the test fecal sample.
2. External controls: It is recommended to use external positive
controls. The external positive controls are not provided with this
kit, but are commercially available from Epitope Diagnostics.
External controls are used to assure that the test line antibody is
reactive. However, external controls will not detect an error in
performing the patient sample test procedure. It is
recommended that the external control be tested once per kit.
Follow local, state, and federal guidelines for running quality control.