Instructions for the Early Pregnancy Tests Strips
HOW DOED EARLY PREGNANCY TESTS
STRIPS WORK ?
Human chorionic gonadotropin
(hCG) is a hormone, produced by the developing placenta shortly after the
conception and secreted into the urine. The pregnancy test strip contains
antibodies which specifically react with this hormone.
When
the pregnancy test strip is immersed into a
urine specimen, capillary action carries the specimen to migrate along the
membrane. When hCG in the sample reaches the Test Zone region of the
membrane, it will form a colored line. Absence of this colored line suggests
a negative result. To serve as a procedure control, a colored line will appear
at the Control Zone region of the pregnancy test strip, if the test has
been performed properly.
WHAT YOU NEED BEFORE HAVING THE
PREGNANCY TEST at Home?
1. A clean, dry, and plastic
or glass container to collect the urine for the pregnancy test.
2. A timer (watch or clock).
PRECAUTIONS:
1. This
pregnancy test
kit is for
external use only. Do not swallow the pregnancy test strip.
2. Discard the
pregnancy test stips
after
first use. The pregnancy test strip can't be used more than once.
3. Do not
touch the
pregnancy test strip
membrane
area.
4. Once
open the pouch, the test device (pregnancy
test strip) should be
used immediately. Prolonged exposure to ambient humidity will cause pregnancy
test strip
deterioration.
5. Do not use test kit (pregnancy
test strip)
beyond expiry date.
6. Do not use the
pregnancy test strip
if the punch is punctured or not well sealed.
7. Keep
the pregnancy test strip
out of the
reach of children.
STORAGE AND STABILITY:
1. Store the pregnancy test
strips 4~30C in the sealed punch up to the expiration dates.
2. Keep the pregnancy test strips
away from sunlight, moisture and heat.
3. DO NOT FREEZE the pregnancy
test strips.
4. Preferably open the
pouch only shortly before the pregnancy test.
SPECIMEN COLLECTION
AND PREPARATION
WHEN TO
COLLECT URINE FOR THE PREGNANCY TEST?
Any urine
specimen is appropriate for Pregnancy Testing but the first
morning urine specimen is optimal because of its highest
concentration of HCG.
HOW
TO DO THE PREGNANCY TEST ?
1. The
HCG early pregnancy home
tests strips and urine have
to be at room temperature (15-30°C) for testing.
2. Remove the HCG pregnancy test strip from the sealed pouch.
3. Immerse the HCG pregnancy test strip into the urine with the arrow pointing
towards the urine. Take the strip out after 3 seconds and lay the strip
flat on a clean, dry, non-absorbent surface (such as the mouth of the
urine container).
IMPORTANT: Do not allow the urine level to exceed the MAX (marker
line), otherwise the pregnancy test will not perform correctly.
4. Read results in five minutes.
Do not read the pregnancy test results after more than 5 minutes.

5.
Discard the
pregnancy test strip
after single use in the dustbin.
HOW TO READ THE PREGNANCY
TEST RESULTS
Negative (not pregnant):
Only one color band appears in
the Control Zone of the
pregnancy test strip.
No apparent band on the Test Zone. This indicates that no pregnancy has been
detected.
Positive (pregnant):
Distinct color bands appear
in the Control and Test Zones of the
pregnancy test strip.
It indicates that you are pregnant. The color intensity of the test bands
may vary since different stages of pregnancy have different concentrations of
HCG hormone.
Invalid:
No
visible band at all on the
pregnancy test strip
or there is a visible band
only in the test region and not in the control region. Repeat with a new test
kit. If test still fails, please contact the distributor or the store, where you
bought the product, with the
pregnancy tests strips
lot numbers.

NOTE: if the color in the Test
Zone is weak, it is recommended that the test be repeated in 48 hours.
WHAT TO DO WHEN YOU KNOW THE
PREGNANCY TEST RESULT
IF THE PREGNANCY TEST RESULT IS
POSITIVE (TWO LINES)
Consult your physician. He should confirm your
pregnancy after evaluating all clinical and laboratory findings. Indeed,
in certain conditions, the
pregnancy tests strips may
give a false positive result. He will also give you further information and
advice on your pregnancy.
IF THE PREGNANCY TEST RESULT IS
NEGATIVE (ONE LINE)
If you have reasons to believe that
you are pregnant (e.g. no menstrual bleeding), you can repeat the
pregnancy test
a few days later. If the test is
still negative, consult your physician.
LIMITATIONS
1. As it is with any diagnostic procedure, a confirmed pregnancy diagnosis
should only be made by a physician after evaluating all clinical and
laboratory findings.
2. If a urine sample is too dilute (ie, low
specific gravity) it may not contain a representative level of hCG.
If pregnancy is still suspected, another urine specimen should be
collected 48 hours later and tested.
3. Low concentration of hCG in a very early
pregnancy can give a negative result. In this case, another
specimen should be obtained at least 48 hours later and tested.
4. Elevated levels of hCG can be caused by
a few conditions other than pregnancy. Therefore, the presence of hCG in
urine specimen should not be used to diagnose pregnancy unless
these conditions have been ruled out.
5. A normal pregnancy cannot be distinguished
from an ectopic pregnancy based on hCG levels alone. Also, spontaneous
miscarriage may cause confusion in interpreting test results.
6. Sterility treatments, based on hCG, may
cause false results. Consult your physician.
EXPECTED RESULTS
Negative results are expected
in healthy non-pregnant women and healthy men. Although the hCG levels in normal
early pregnant women are variable, One Step Strip Urine HCG Test is
capable of detecting pregnancy as early as 1 day after the first missed menses.
QUESTIONS &ANSWERS
1. There is much difference between the control
lines of two pregnancy tests. Is this a concern? No. Variations in the
color of the control band will not affect the pregnancy test result.
2. Can pregnancy test results be interpreted
after more than five minutes? No. Test results must be read in 5
minutes. Though a positive result should not change for several days, a
negative result may change to a false positive within minutes after the
end of the testing period, which would not be an accurate reading. It is
always best to read the results at the 5 minute testing period and then
discard the test to avoid confusion.
3. A pink background color and
vertical streaking appeared in the
pregnancy test strip
result area during the testing period. Is this
a concern? No. Each urine sample will vary in its chemical makeup, as
will the humidity of the air in pregnancy testing chamber (room). Such
variations in physical conditions can cause the vertical streaking and/or
the pink-rose background color but will not affect the pregnancy test
results. As long as the control band appears within five minutes,
the pregnancy test is working properly.
************************************************************************End
of instruction***************************************************

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