VN

Asan Easy Test H.Pylori Ag

Code: 208

 

 INTENDED USE

The Asan Easy Test® H. pylori Ag is a qualitative test for visual detection of H. pylori
(Helicobacter pylori) Ag in human stool. It is intended for health care professional use as
an aid on the diagnosis of H. pylori.

EXPLANATION OF THE TEST

The Asan Easy Test® H. pylori Ag employs a solid phase chromatographic immunoassay
technology to qualitatively detect H. pylori Ag in human stool. For diagnosis H. pylori Ag
in human stool, specific monoclonal antibodies against H. pylori antigen was used as a
capture materials. The test contains the membrane pre-coated with specific monoclonal
antibodies against H. pylori antigen on the test line region. During test, the sample is
allowed to react with specific monoclonal antibodies against H. pylori antigen conjugated
with colloid gold, which has been pre-dried on the conjugate pad between membrane
and sample pad. The mixture then moves upward on the membrane by capillary action.
For positive result, a visible line with high sensitivity and specificity as forming Ag-AbGold complex appears in the test band region(T) of the membrane. Regardless of the
presence of H. pylori Ag, the mixture continuously moves across the membrane to
predried control line. The control band region(C) will always appear and verify proper
performance of the test.

MATERIALS PROVIDED

Asan Easy Test® H. pylori Ag contains following items to perform the assay.
1. Test device in aluminium pouch with a desiccant.
2. Sample collection tubes with assay buffer.
3. Instructions manual for use.

PRECAUTIONS

1. For in-vitro diagnostic use only
2. The test kit should remain in the sealed pouch until ready for use.
3. The test kit is sensitive to humidity and to heat.
4. Do not smoke, eat or drink in areas where specimens or kit component are handled.
5. All specimens and reagents should be considered potentially hazardous and handled in
the same manner as an infection agent.
6. Wear protective gloves while handling samples and wash hands thoroughly after the
assay is complete.
7. Avoid any contact with the eyes, broken skin or mucous membranes.
8. The test device and all materials should be discarded in a proper biohazard container
after testing.

SPECIMEN COLLECTION AND STORAGE

1. Specimens should be obtained and handled by specialist in accordance with standard
feces collection method.
2. The test should be performed using fresh human feces.
3. Specimens must be tested as soon as they are collected. If necessary, they may be stored
at 2~8
for up to 48hours or at -20
oC for longer periods.
4. Fecal specimen in the assay buffer are stable for up to 3 days at room temperature or at
2~8
for longer periods.

TEST PROCEDURE

1. All materials should be equilibrated to room temperature before performing the test.
2. Remove the test device from its protective pouch.

3.Take a portion of stool from inside and surface of specimens at 5~6 different sites
thoroughtly.

4.Unscrew a cap.
5.Insert the swab with specimen into the sample collection tube and swirl the swab at
least 10times.

6.Discard the swab squeezing against the wall of the tube.
7.Shake the sample collection tube thoroughly to mix with specimen and assay buffer.
8.Unscrew another cap on the top of sample collection tube and discard 1~2 drops of
buffer.

9.Hold the collection tube vertically and dispense 2drops (about 100) of buffer into
sample well(S) of the test device.
1
0.Interpret test results at 10~15 minutes. Do not interpret after 15 minutes.
(NOTE: The above interpretation time is based on reading test results at room temperature
(15~30
℃ ). If your room temperature is significantly lower than 15, the interpretation
time may be increased. A low H. pylori antigen concentration might result in a weak line
appearing in the test region (T) after an extended period of time; therefore, do not interpret
the result after 15 minutes)

INTERPRETATION OF THE TEST

A. NEGATIVE RESULTS:
The presence of only one purple color band (“C” band) within the window indicates a
negative result.

B. POSITIVE RESULTS:
The presence of two color bands (“T” band and “C” band) within the result window
regardless of which band appears first indicates a positive result.

C. INVALID RESULTS:
If No band is visible within the window after performing the test, the result is considered
invalid. Some causes of invalid results are: not following the directions correctly or the
test may have deteriorated beyond the expiration date. It is recommended that the
specimen be re-tested using a new test kit.

LIMITATIONS OF THE TEST

1. Other clinically available tests are required if questionable results are obtained. As all
diagnostic tests, a definitive clinical diagnosis should not be based on the results of a
single test, but be made by the physician after all clinical and laboratory findings have
been evaluated.
2. Antibiotics, PPI (proton pump inhibitors) and bismuth preparations inhibit H. pylori.
Negative test results obtained during or shortly after a therapy might be false negative.
3. For accurate diagnosis of follow-up, It is recommend to perform at least 4weeks after
eradication therapy.

STORAGE & EXPIRATION

1. Asan Easy Test® H.pylori Ag should be stored at 2 to 30℃ (35.6-86 ℉ ).

2. Expiration date of this kit is 24 months after its manufacture date.

BIBLIOGRAPHY
1. Accuracy of the stool antigen test in the diagnosis of Helicobacter pylori infection
before treatment and in patients on omeprazole therapy. G.Manes, A.Balzano,
G.Iaquonto, et al. Aliment Pharmacol Ther 2001;15;73-79.
2. Evaluation of two enzyme immunoassays for detecting Helicobacter pylori in stool
specimens of dyspeptic patients after eradication therapy. Y.Erzin, S.Altun, A.Dobrucali,
M.Aslan, S.Erdamar, A.Dirican and B.Kocazeybek. Journal of Medical Microbiology
2005;54;863-866.
3. Review : Current Role of Helicobacter pylori Stool Tests. Frank Serge Lehmann,
Christoph Beglinger. Digestion 2003;68:119-123.
4. Evaluation of a Monoclonal Antibody-based tests for Detection of Helicobacter
pylori-Specific Antigen in Stool Samples from Mice. Julia Crone, Erin Symonds,
Fiona Campbell, and Ross Butler. Clinical And Diagnostic Laboratory Immunology.
2004;11;799-800.

Comments

Other products

The Influenza A&B Rapid Test Strip (Swab) is a rapid chromatographic immunoassay for the qualitative detection of influenza A and B antigens in nasal swab specimens. It is intended to aid in the ...
The Syphilis Ultra Rapid Test Strip (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in whole ...
The HCV Hepatitis C Virus Rapid Test Strip (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibody to Hepatitis C Virus in serum or plasma.
The HCV Hepatitis C Virus Rapid Test Device (Serum/Plasma) is a rapid chromatographic immunoassain or the qualitative detection of antibody to Hepatitis C Virus in serum or plasma C For ...
The HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to HIV 1 and/or HIV 2 in whole ...
The HBsAg One Step Hepatitis B Surface Antigen Test Device(Serum/Plasma) is a rapid chromatographic immunoassay for thequalitative detection of Hepatitis B Surface Antigen in serum orplasma.
Asan Easy Test® COVID-19 Ag is an in vitro diagnostic medical device that diagnoses COVID-19 by qualitatively testing SARS-CoV-2 nucleocapsid protein antigen in nasopharyngeal swab by ...
Updating....