Download OneStep H. Pylori

OneStep H Pylori #118561 Test
Atlas Link
InstaTest H. Pylori
OneStep H. Pylori
Serum Test
SPECIMEN COLLECTION
1.
2.
Catalog # 118561-50 (50 tests)
Read the instruction before performing assays. Follow
the procedures during testing.
3.
Serum specimen may be collected following standard
clinical procedure.
Serum specimens can be stored at room temperature
(20°C to 28°C) for 4 hours, at 2o-8oC for 48 hours, and
at -20°C or lower for prolonged storage. Repeatedly
frozen and thawed specimens are not recommended for
this assay.
Any sediment in serum specimens should be removed by
centrifugation. Avoid using any turbid specimens,
which may be contaminated by microorganisms.
SUMMARY
The infection of Helicobacter pylori 1 (H. pylori, spiralshaped bacterium) is associated with a variety of gastrointestinal diseases, such as stomach ulcer, chronic active
gastritis
and
gastric,
duodenal,
and
gastric
adenocarcinoma2,3,4,5,6,7,8.
Antibodies to H. pylori are
developed in Individuals infected with H. pylori as a
serological response9,10. Detecting these specific antibodies
to H. pylori can be used as a qualitative assay in the
diagnosis of H. pylori infection. It may be used either as an
adjunct to endoscopy or as an alternative measure in
symptomatic patients.
PRECAUTIONS
1.
2.
3.
4.
FOR IN VITRO USE ONLY.
Do not use test kit beyond expiration date.
Do not open the test device foil pouch until you are
ready to perform the test.
Icteric, lipemic, hemolysed, heat treated and
contaminated sera may cause erroneous results.
PROCEDURE
PRINCIPLE
The Atlas Link Diagnostics H. pylori one-step assay is a
lateral flow, chromatographic immunoassay (CIA),
containing filter membrane pre-coated with H. pylori
specific antigens and colored gold colloidal reagents labeled
with H. pylori specific antigens. There are two regions on
the membrane of the test strip, test region (T) and control
region (C). A T line, the burgundy colored band in the test
region of membrane, will be developed rapidly (after 30
seconds) when antibodies to H. pylori present in specimen.
If antibodies to H. pylori are not present, no T line will be
developed in the test region. A C line, a burgundy colored
band in the control region of the test strip, should always
appear regardless of the presence of antibodies to H. pylori
serving as a internal qualitative control of the test system.
REAGENTS and MATERIALS
1.
2.
Test Device: Each contains a test strip.
Dilution buffer.
1.
Refrigerated specimens or other materials should be
equilibrated to room temperature right before
performing testing.
2.
Remove the device from its protective pouch. Label the
device with specimen identification.
3.
Add 20l of serum specimens into the sample well,
Add four drops (about 200 l) of dilution buffer into the
sample well.
4.
Positive results may be observed as soon as 30 seconds
after the specimen reaches the viewing window,
depending on the concentration of antibodies to H.
pylori in the tested specimen. To confirm negative
results, total of 5 minutes, a complete reaction time is
required.
INTERPRETATION of RESULTS
STORAGE
The kit should be stored at room temperature (15-30°C) or
refrigerator (2-8°C) in the sealed pouch with desiccant for
the duration of the shelf life (18 months).
Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, [email protected]
OneStep H Pylori #118561 Test
1.
1.
2.
3.
C
T
C
T
C
T
S
S
S
POSITIVE
NEGATIVE
INVALID
Positive Two pink-rose bands appear: one in the test region
(T) and in the control region (C).
Negative One rose-pink band appears in the control region
(C), with no band in the test region (T).
Invalid There is no distinct color band visible both in the test
region and in the control region, or there is a visible band only
in the test region and not in the control region. The result is
invalid due to deterioration of the test or improper test
procedure. Repeat the test with a new Testing Device.
LIMITATIONS
1.
This test is a qualitative assay. To confirm diagnosis of
gastritis and/or peptic ulcers, clinical findings need to be
considered.
2.
Serum samples from patients infected with C. Jejuni
may have a low cross-reactivity with this test.
3.
A negative result can not rule out H. pylori infection.
Because the antibody to H. pylori may be absent or may
be insufficient to be detected at the time of testing.
Warren, J.R. and Marshall, B. (1983) Unidentified
curved bacillus on gastric epithelium in active chronic
gastritis (letters). Lancet 1: 1273-1275.
2. Anderson, L.P. and Nielsen, H., (1993) Peptic ulcer: an
infectious disease? Ann. Med. 25: 563-568.
3. Dixon, ME, IV. (1991) Helicobacter pylori and peptic
ulceration histpathological aspects. H. Gastro. Hepa. 6:
125-130.
4. Hunt, R.H. and Mohamed, A.H. (1995) The current role
of Helicobacter pylori: eradication in clinical practice,
Scand. J. Gastroenterol. 30 suppl 208: 47-52
5. Lambert, J.R.; Lin, S.K. and Aranda-Michel, J. (1995)
Helicobacter pylori, Scand. J. Gastroenterol. 30 suppl.
208: 33-46
6. Warren, J.R. and Marshall, B. (1984) Unidentified
curved bacillus in the stomach of patients with gastritis
and peptic ulcer disease. Lancet 1: 1273-1275.
7. O’Connor, JH (1992) Helicobacter Pylori and gastric
cancer: a review and hypothesis. Eur. J. Gastro. Hepa.
6: 103-109.
8. Parsonnet, J, et al.(1991) Helicobacter Pylori infection
and the risk of gastric carcinoma. N. Eng. J. Med. 325.
1127-1131.
9. Vaira, D. and Holton, J. (1989) Serum immunoglobulin
G antibody levels for Campylobacter pylori diagnosis.
Gastroenterology 97: 1069-1071.
10. Evans, D.J., Evans, D.G., Graham, D.Y. and Klein, P.D.
(1989) A sensitive and specific serologic test for
detection of Campylobacter pylori infection.
Gastroenterology 96: 1004-1008
REFERENCES
Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, [email protected]