Product Manual

INTENDED USE
O
SOM H. pylori Test qualitatively detects anti-Helicobacter pylori IgG antibody in human
whole blood, serum, or plasma specimens. This test is intended for use as an aid in the
diagnosis of H. pylori infection in adult patients with symptoms of gastrointestinal disorders.
S
UMMARY AND EXPLANATION OF TEST
Helicobacter pylori, formerly known as Campylobacter pylori, are gram-negative
microaerophilic spiral bacteria that have been identified and cultured since 1983
1
. They
c
an colonize the gastric mucosa for years
2
,
and their presence is strongly associated with
chronic, diffuse, superficial gastritis of the fundus and antrum
3-5
. As a result, they are now
believed to have an etiologic role in gastritis
6,7
. Recent evidence suggests that H. pylori
gastritis may progress over several decades to chronic atrophic (type B) gastritis
8,9
, a
lesion that is a precursor of gastric carcinoma. The epidemiologic features of gastric car-
cinoma and H. pylori infection are similar
10
, and recent studies suggest that H. pylori
infection may be a risk factor for gastric carcinoma
11,12
.
Until recently, diagnosis of infection with H. pylori required endoscopy and identification of
the organism by means of subsequent culture of the bacteria and/or recognition of spiral
organisms in histologically evaluated sections of gastric tissue. However, the expense and
invasive nature of this procedure make endoscopy impractical for epidemiologic studies.
Serology has become the method of choice for such studies. There is excellent correlation
between a classical clinical presentation of gastritis, the presence of H. pylori in the
stomach and elevated serum levels of anti-H. pylori antibodies
13-15
. Positive results can justify
a short empirical trial of antimicrobial therapy in gastritis of unknown origin, and response to
treatment can be serially monitored because levels of H. pylori -specific IgA/IgG/IgM anti-
bodies can be expected to fall significantly after successful antibacterial therapy
16
.
PRINCIPLE OF TEST
The OSOM H. pylori Test utilizes indirect solid-phase immunoassay technology for the
qualitative detection of H. pylori antibodies. OSOM H. pylori consists of H. pylori antigen
on the test membrane and H. pylori antigen plus anti-human immunoglobulin antibodies
coated on gold particles in the dye pad. Thus, in principle, the results of OSOM H. pylori
may differ from the results of assay using only anti-IgG as a detector. In the test procedure,
patient specimen is added in the upper area of the Sample well (S) located below the
Result window. The Developer solution is then added in the Sample well. The solution
mobilizes the dye conjugated to H. pylori antigen and to anti-human immunoglobulin
antibodies. If any anti-H. pylori antibody is present in the sample, the dye conjugate will
bind to the H. pylori antigen band impregnated on the test membrane. Visualization of
the antigen band at the Test position (T) will occur only when the anti-H. pylori antibody is
present in the sample. As the antibody-dye conjugate continues to move along the test
membrane, it will be captured by a species specific antibody located at the Control
position (C) to generate a colored band regardless of the presence of H. pylori antibod-
ies in the sample. The presence of two colored bands, one at the Test position and the
other at the Control position, indicates a positive result, while the absence of a colored
band at the Test position indicates a negative result.
REAGENTS AND MATERIALS PROVIDED
Each test kit contains enough reagents and materials to perform all of the tests. Each
OSOM H. pylori Test device contains a membrane strip coated with H. pylori antigen and
a pad with indicator conjugates in a protein matrix.
25 Test devices individually pouched
25 Capillary tubes
Developer solution containing 0.09% sodium azide
1 Directional Insert
MATERIALS REQUIRED BUT NOT PROVIDED
A clock or timer
Vacutainer tubes for either serum or plasma procedure
Anticoagulant (i.e., CPDA-1, heparin, or EDTA) for plasma
Centrifuge
Lancet
FOR LABORATORY AND PROFESSIONAL USE ONLY
I V D
osom
®
H.pylori Test
CLIA Complexity: Waived for Whole Blood;
Non-waived for Serum or Plasma