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HemosureTM
Fecal Occult Blood (FOB) Test Strip
WARNING
For IN VITRO
DIAGNOSITC USE ONLY
1. Do not use
beyond the labeled expiration date.
2. Do not reuse
disposable test devices. Discard in a safe place after
single use.
3. Do not use if
pouch is damaged or opened.
4. Do not touch
the membrane located within the windows.
5. Once open the
pouch, the test device should be used immediately. Prolonged
exposure to ambient humidity will cause product
deterioration.
PRECAUTIONS
1.Read directions
for use carefully before performing this test.
2. Treat feces
samples and used devices as if they are potentially
infectious. Proper precautions in handling should be
maintained according to good laboratory practice. Avoid
contact with skin.
INTENDED USE：
HemosureTM immunological FOB test
is a rapid, convenient and odorless qualitative, sandwich
dye conjugate immunoassay for the determination of human
occult blood in feces, and is a useful aid in the diagnosis
and therapy of gastrointestinal disorders.
SUMMARY AND EXPLANATION：
The guaiac method
was developed by Van Deen in 1864 to detect occult blood.
Boas began to use this method in 1901 to diagnose gastric
bleeding. Since that time, numerous improvements have been
introduced which
utilize the peroxides activity of heme. However,
in order to get accurate test results, guaiac based tests require
that certain foods, drugs, vitamins and other substances
should be avoided before and during the sample collection
period. Several authors have also found that some patients
with colorectal cancer or adenoma tested negative
for occult blood because
of the lack of sensitivity of
guaiac based methods.
Subsequent development of latex immunochemical
agglutination and of the single radial
immunodiffusion(SRID)
and of the
reverse-passive hemagglutination(RDHAA)have produced test methods
more sensitive to low concentrations of human occult blood
in feces. The results of clinical studies indicate that test
results are positive in only about 50-60 percent of patients with
colorectal cancers and only 25-30
percent of patients with polyps. Therefore, a more sensitive
means for detecting fecal occult blood is important for the
diagnosis of diseases that result in gastrointestinal
bleeding. HemosureTM
lmmunological FOB test actually
detects lower levels of fecal occult blood than the standard
guaiac tests by
employing an immunospecific, double-sandwich capture
method without any restriction on foods and drugs.
PRINCIPLE：
HemosureTM lmmunological FOB test
is a
qualitative, sandwich
dye conjugate immunoassay and employs a unique
combination of monoclonal and polyclonal antibodies
to selectively identify hemoglobin in test samples with a
high degree of sensitivity. In less than five minutes,
elevated levels of human hemoglobin as low as 0.2ugHb/ml can
be detected and positive results for high levels of
hemoglobin can be seen in the test as early as one or two
minutes.
As the test
sample flows up through the absorbent device, the labeled
antibody-dye conjugate binds to the hemoglobin in the
specimen forming an
antibody-antigen complex. This complex binds to
anti hemoglobin antibody in the positive test
reaction zone and produces a pink-rose color band. In the
absence of hemoglobin, there is no line in the positive test
reaction zone. The pink-rose color bands in the control
reaction zone demonstrate that the reagents and devices are
functioning correctly.
REAGENTS
1.HemosureTM
lmmunological FOB test one test per foil pouch.
Ingredients: contains a combination of mouse monoclonal antibodies
and polyclonal
antibodies (sheep or goat) directed against human
hemoglobin. Mouse monoclonal antibody on a colloidal gold
particle.
2. Buffer
solution. 2 ml preservative
buffer with 0.5% (NaN3)
MATERIALS PROVIDED
Each HemosureTM lmmunological FOB test (one cassette or one strip)
individually sealed in a foil pouch, and sample collection
tube
A.
Each pouch contains:
1.One
HemosureTM lmmunological fecal
occult blood test.
2. Desiccant
B.Sample
collection tube
Contains: 2 ml preservative
buffer with 0.5%(NaN3)
Material required
but not supplied:
Timer, sample container and disposable
gloves.
No other
equipment or reagents are needed.
STORAGE
Sample collection
tube after collecting sample should be stored
refrigerated(4-8℃) if not used
immediately. Store test device at 4-30℃(room
temperature). The test is stable until the expiration date
imprinted on the pouch.
Procedure
Sample Collection (see1)
1.Loosen cap of
specimen collection tube and remove applicator stick;
2.Introduce the
applicator stick into the fecal sample six times at
different sites so as to get sampling even at spirals;
3.Return the
applicator stick to the specimen collection tube and tighten
the cap thoroughly and shake the tube so as to suspend the
liquid in the tube.
Test Procedure:
1.Remove the
“reaction device” from its foil wrapper by tearing along the
”slice”;
2.Shake well the
collection tube to ensure that the fecal sample is well
mixed;
3.Break off the
tip of the cap on the container and discard two or three
drops (see2.3)
4.Read results
within five minutes.
DO NOT INTERPRET
RESULT AFTER 10 MINUTES.
5.Discard the test device after
single use in an appropriate place.
Result Reading:
1.Positive:
One band appearing in the “C” region, the other in the “T”
region, the blood occult is positive; (see 4)
2.Negative:
Only one color
band appearing in the “C” region, the blood occult is
negative; (see5)
3.Invalid:
No color bands appearing in the window at all, the test
result is invalid. (see6)
It is recommended that in this case the test be repeated or
a fresh specimen be obtained and tested 48 hours later.
Notes
◆
Do not drop fecal
sample liquid into result windows;
◆
Read results
within 5 minutes. Do not read results after 10 minutes;
◆
Period is 18
months and do not use products after expiration date;
◆
Sample collection tube after
collecting sample should be stored refrigerated(4℃-8℃)
if not used immediately.
◆
Avoid internal
use and children touching.
PERFORMANCE CHARACTERISTICS：
1.SENSITIVITY
Positive
results can be seen in the tests when the levels of human
hemoglobin in feces as low as 0.2 ugHb/ml.
2.SPECIFICITY:
HemosureTM
is specific for human hemoglobin, sample containing
following substances have no effect on the test result.
Turkey
hemoglobin 500ug/m
Pig(Pork)hemoglobin 500ug/ml
Bovine(Cow)hemoglobin 500ug/ml
Horse
hemoglobin 500ug/ml
Pigeon
hemoglobin 500ug/ml
Radish
Peroxidase 2000ug/ml
QUALITY CONTROL
Built in Quality
Control Features
When the test is complete, a pink-purple colored band will
show in the ”C” control area of the test strip on both
negative sample and positive sample. The appearance of the
“C” control band indicates that the test strip is performing
properly and serves as a built in quality control.
Limitation for the procedure
1.
Hemosure Immunological FOB Test is a valuable aid
in the early detection of colorectal bleeding device.
However, since bowel lesions, including some polyps and
colorectal cancers, may not bleed at all or may bleed
intermittently, or the blood may not be uniformly
distributed in a fecal sample, a test result maybe negative
even when disease is present.
2.
Hemosure Immunological FOB Test results may be
positive for samples from healthy patients. This may be
because certain medications may cause gastrointestinal
irritation resulting in gastrointestinal bleeding.
3.
As with any
occult blood test, Hemosure Immunological FOB Test
may not be considered as a conclusive diagnosis for
gastrointestinal bleeding or pathology, they can only be
regarded as a preliminary screening or as an aid to
diagnosis. They are not intended to replace other diagnostic
procedures such as EGD, colonoscopy or other X-ray studies.
4.
As with all
diagnostic tests, a definitive clinical diagnosis should not
be based on the results of a single test, but should only be
make by the physician after all clinical and laboratory
findings have been evaluated.
REFERENCE
1. Boad,
I. (1901) Uber Okkulte Magenblutungen. Dtsch Med Wochenschr
27:315-321.
2. Van
Deen, J. (1984) Tincture guaijaci, und ein Ozontrager, als
Reagens auf sehr geringe Blutmengen, namentlich in
medicoforensischen fallen. Arch Holland Beitr Natura Heilk
3:228-231
3. Adams,
E.C., Layman, K.M. Immunochemical confirmation of
gastrointestinal bleeding. Ann.elin. Lab. Sci. 4:343; 1974.
4. Saito,
H., et al. An immunological occult blood test for mass
screening of colorectal cancer by reverse-passive
hemagglutination (RPHA). Japanese J. Gastroenterology.
61:2831; 1984
5.
Heinrich, H.C. (1984) Ultrasensitiver immunochemistry
okkultblutnachweis im Stuhl. In: Fruhmorgen P (ed)
Pravention und Fruherkennung des kolorektalen Karinoms, 1st
edn. Springer, Berlin Heidelberg New York, pp. 59-82.
Date of last revision:
2002-9-20
