One Step HCG Urine Pregnancy Test (Strip)
One Step HCG Urine Pregnancy Test measures the
presence of the hormone Human Chorionic
Gonadotrophin (HCG) in your urine for the early detection
SUMMARY AND EXPLANATION:
HCG is produced by the placenta during pregnancy,
shortly after the embryo attaches to the uterine lining. The
further in to the pregnancy you are the higher the levels of HCG in your urine. The concentration of HCG in
non-pregnant women is normally >5.0mIU/ml. At the time
of the last missed menstrual period, urine HCG levels are
about 50mlU/ml with peak levels of 100,000 to
200,000mlU/ml seen at the end of the first trimester.
Each pouch contains:
- One Step HCG Urine Pregnancy Strip Test.
- Desiccant (Discard - Do not eat).
- Package insert.
STORAGE AND STABILITY:
The test kit can be stored at room temperature (2 C to 30
C) in the sealed pouch to the date of expiration. The test
kits should be kept away from direct sunlight, moisture
FOR IN -VITRO DIAGNOSTIC USE ONLY
- Read directions for use carefully before performing
- Do not use the test beyond the expiration date on the
- Each test strip can only be used once; do not re-use
the test strips. Discard each test after use.
- Do not use if the foil pouch is damaged or has been
- Hold the test strip by the handle only.
- Once the foil pouch has been opened, the test should
be used immediately.
- Treat urine samples and used tests as if they are
potentially infectious. Avoid contact with skin.
WHEN CAN I CARRY OUT THE TEST?
You can take this pregnancy test from the first day you
suspect you might be pregnant.
SPECIMEN COLLECTION AND HANDLING
A urine specimen must be collected in a clean and dry
container. The first morning urine specimen is preferred
since it generally contains the highest concentration of
HCG; however, urine specimens collected at any time of
the day may be used.
TO CARRY OUT THE TEST:
1. Bring the test pouch and urine to room temperature. To begin testing, open the sealed pouch and remove the strip.
2. Place the test strip vertically (straight) into the urine
sample for at least 10 seconds, making sure the
arrows are pointing downwards. Do not allow the
urine level to go above the MAX (maximum) level
line (marked by arrows) on the test strip.
3. Remove the strip from the urine and place the strip
on a clean, dry surface.
4. Wait for the coloured bands to appear. Positive
results may be visible within 1 minute but to confirm a
negative result wait up to 5 minutes and until the
background is clear. Results obtained after 5 minutes
may be considered invalid.
5. Discard the test after use.
INTERPRETATION OF RESULTS:
Negative: If one coloured line appears in the control
region on the test strip and there is no line in
the test region, then this indicates a negative
result, no HCG has been detected in the urine.
This means you are either not pregnant or you
have tested too early. If you are not sure
repeat the test in 48 hours.
Positive: If two coloured lines appear on the test strip,
one in the test region and one in the control
region, then this means there is a strong
possibility that you are pregnant — HCG has
been detected in your urine. One line may be
lighter than the other, they do not have to
match and this is still a positive result.
Invalid: If a red line appears in the test region but there
is no visible line at all in the control region of
the strip then the test is invalid. If no lines
appear anywhere on the test strip then the test
is also invalid and should be repeated using
another test strip.
Built in Quality Control Features:
After addition of the urine sample, coloured bands migrate
along the membrane at the leading edge of the dye
conjugate and are “removed” from the test strip
When the test is complete, you will see a pink-purple
coloured band in the “C” area of the test strip on negative
samples and a pink-purple coloured band in the “T” and
“C” area on positive samples. The appearance of the
CONTROL band indicates that the test strip is performing
properly and serves as a procedural control.
Comparison studies on the One Step HCG Urine
Pregnancy Test with a legally marketed device were
performed in-house and in a clinical reference laboratory.
Positive and negative results were compared and the
correlation was 99.5%.
The HCG assay is a rapid one-step test, based on an
immunochromato graphic technology. A membrane with
an absorbent pad overlapping a strip of fibre glass paper
that is impregnated with a lyophilized colloidal conjugate
of gold particles and monoclonal solid phase antibodies to
HCG. Other absorbent pads at the end of the assay
absorb excess sample fluid. The urine sample is
introduced into the device, and proceeds through the
absorbent pad, then laterally onto a chromatographic
membrane. As it contacts the membrane, the sample
dissolves the lyophilized conjugate. In a reactive sample,
the HCG antigen will attach to the antibodies in the
colloidal solution. As the conjugate moves forward on the
membrane, anti-HCG monoclonal antibody affixed on the
test zone (“T”) will bind the HCG-gold conjugate complex,
forming a pink line (“T”). All samples will cause a pink
colored line to appear in the control zone (“C”).
This line is formed by the binding of the polyclonal
antibodies (Anti-mouse IgG) affixed onto the control zone
to the sample-colloidal gold conjugate. Presence of this
line indicates that the test has been carried out correctly.
All Fastest One Step HCG Urine Pregnancy Tests will
display positive results with specimens containing HCG at
the level close to or greater than 10mlU/ml or close to or
greater than 25mlU/ml depending on which test you have purchased.
One Step HCG Urine Pregnancy Test strip per foil
Ingredients: Test device comprised colloidal gold coated
with anti β-HCG antibody；NC membrane coated with
mouse anti α-HCG antibody and rabbit anti mouse IgG.
LIMITATION OF THE PROCEDURE:
1. Alcohol may interfere with the test result. It is not
recommended to use the test after drinking alcohol.
2. If you test too early HCG levels may still be low and so can give a negative result. In this case, another
urine specimen should be obtained at least 48 hours
later and tested.
3. HCG levels may remain detectable for several weeks
after normal delivery, delivery by caesarean section,
spontaneous abortion or therapeutic abortion.
4. In cases where very high levels of HCG are present
(>500,000mlU/ml) a false negative result can occur
due to a “Prozone” effect. If pregnancy is still
suspected, simply dilute specimen 1:1 with deionized
water and retest.
5. 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, a first morning urine
sample should be obtained and retested 48 hours
6. As is true with any diagnostic procedure, the user
should evaluate data obtained by the use of this kit in
light of other clinical information and consult their
doctor for the final diagnosis of pregnancy before
making any decision of medical relevance.
Maximum 90 Strips per Order