OneStep H Pylori #118562 Test
Atlas Link
InstaTest H. Pylori
2.
3.
OneStep H. Pylori
Whole blood/Serum Test
Catalog # 118562-50 (50 tests)
Read the instruction before performing assays. Follow the
procedures during testing.
SUMMARY
4.
Finger-stick is recommended to collect fresh whole blood
specimen for this assay. Wipe fingertip with alcohol, then
prick fingertip with a lancet in a quick motion.
Serum specimens can be stored at room temperature
(20°C to 28°C) for 4 hours, at 2 o-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.
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
denocarcinoma2,3,4,5,6,7,8.
Antibodies to H. pylori are
developed in Individuals infected with H. pylori as a
serological response 9,10. 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
PRINCIPLE
2.
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 (from 30 seconds to 5 minutes) 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.
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
1.
3.
4.
5.
Refrigerated specimens or other materials should be
equilibrated to room temperature right before performing
assay.
Remove the device from its protective pouch. Label the
device with specimen identification.
Add 40l fresh whole blood (or 20l serum) of specimens
into the sample well.
Add four drops (about 200 l) of dilution buffer into the
sample well.
Positive results may be observed as soon as 30 seconds
after the specimen reaches the results 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
REAGENTS and MATERIALS
1.
2.
Test Device: Each contains a test strip.
Dilution buffer.
C
T
C
T
C
T
S
S
S
POSITIVE
NEGATIVE
INVALID
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).
SPECIMEN COLLECTION
1.
1.
Both fresh whole blood and serum specimen may be
tested with this assay. Following standard clinical
procedure to collect specimens.
2.
3.
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
Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, info@atlaslink-inc.com
OneStep H Pylori #118562 Test
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.
LIMITATION
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.
REFERENCES
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2.
3.
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5.
6.
7.
8.
9.
10.
Warren, J.R. and Marshall, B. (1983) Unidentified curved bacillus on
gastric epithelium in active chronic gastritis (letters). Lancet 1: 12731275.
Anderson, L.P. and Nielsen, H., (1993) Peptic ulcer: an infectious
disease? Ann. Med. 25: 563-568.
Dixon, ME, IV. (1991) Helicobacter pylori and peptic ulceration
histpathological aspects. H. Gastro. Hepa. 6: 125-130.
Hunt, R.H. and Mohammed, A.H. (1995) The current role of
Helicobacter pylori: eradication in clinical practice, Scand. J.
Gastroenterol. 30 suppl 208: 47-52
Lambert, J.R.; Lin, S.K. and Aranda-Michel, J. (1995) Helicobacter
pylori, Scand. J. Gastroenterol. 30 suppl. 208: 33-46
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.
O’Connor, JH (1992) Helicobacter Pylori and gastric cancer: a review
and hypothesis. Eur. J. Gastro. Hepa. 6: 103-109.
Parsonnet, J, et al.(1991) Helicobacter Pylori infection and the risk of
gastric carcinoma. N. Eng. J. Med. 325. 1127-1131.
Vaira, D. and Holton, J. (1989) Serum immunoglobulin G antibody
levels for Campylobacter pylori diagnosis. Gastroenterology 97: 10691071.
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
Atlas Link, 12720 Dogwood Hills Lane, Fairfax, VA 22033 USA
Phone: (703) 266-5667, FAX: (703) 266-5664
http://www.atlaslink-inc.com, info@atlaslink-inc.com