PREGNANCY TEST INSTRUCTIONS
TEST DESCRIPTION
One Step HCG Urine Pregnancy Tests are used for qualitative (visual)
determination of hCG (Human Chorionic Gonadotropin) in urine specimens
for early detection of pregnancy. HCG is a glycoprotein hormone
secreted by developing placenta shortly after implantation. hCG can be
detected in urine and serum of pregnant women as early as 6 to 15 days
after conception. The early pregnancy tests are designed to screen very
low hCG concentrations in this initial hCG development stage.
These tests are specifically designed for professional users (doctors,
clinics, family planning centres) for determination of early pregnancy.
Tests detect hCG in urine in a qualitative format with sensitivity of
20mIU/mL (International Standard Value). The test line is responsive in
the range of 10-50 mIU producing a line directly proportional to
concentration of hCG in urine. The specificity is 99.9% meaning that
test is highly selective for beta-hCG glycoprotein. Tests have an
expiry date of 2 years and can be stored in a dry environment ranging
from 2 to 30 degrees Celsius. The products are manufactured in ISO 9001
facility and posses Health Canada and US FDA 510k clearance. The
product performance has earned an international reputation for quality
and reliability, and are distributed in over 70 countries worldwide.
FORMATS
The tests are available in 3 different formats:
1. STRIP
2. CASSETTE
3. MIDSTREAM
The format applications range from professional to domestic usage.
TEST PROCEDURE
STEP 1
Bring the test pouch to room temperature (18-30°C). Collect urine into
a clean container (such as plastic cup). The best way to collect sample
is by placing a cup in the middle of urination process. To begin
testing, open the sealed pouch by tearing along the notch. Remove the
test from the pouch when you are ready to use it.
STEP 2 (TEST FORMATS)
STRIP TEST
Immerse the strip into the urine with the arrow end pointing towards
the urine. Do not immerse past the MAX (maximum) line. Take the strip
out after 3 seconds and lay the strip flat on a clean, dry,
non-absorbent surface (e.g., mouth of the urine container). Do not
immerse for longer than 5 seconds.
CASSETTE TEST
Draw the sample into the provided pipette, and dispense 0.2ml (about 4 drops) into the round dropping well of the cassette.
MIDSTREAM TEST
Hold the round end of cover with one hand. Use the other hand to pull
out the test device and expose the absorbent window. Point the
absorbent tip downward and place the absorbent tip in urine stream for
at least 10 seconds to be thoroughly wet. Otherwise, you can collect
your urine into a clean cup and dip half of the absorbent pad into the
urine for at least 10 seconds. Re-cap the device and place it on the
clean, flat surface.
STEP 3
Wait for the colored bands to appear. Depending on the concentration of
hCG in the test specimen, positive results may be observed in as short
as 40 seconds. However, to confirm negative results, the complete
reaction time (5 minutes) is required. Do not read the results after 10
minutes as this type of test is designed for rapid determination only.
INTERPRETATION OF RESULTS
Negative - Not Pregnant:
Only one color band appears in the control region. No visible band on
the test region is present since hCG concentration is not present in
urine or too low for detection.
Positive - Pregnant:
Distinct color bands appear on the control and test regions. The
presence of both test and control lines indicate possible pregnancy.
Color intensity of the test band may vary according to the
concentration of hCG in urine. The higher the hCG concentration - the
darker the intensity of the test line, hence higher the likelihood of
pregnancy.
Invalid - Uncertain Results: No visible bands in the control and test
regions. Make sure to follow the above specified instructions for
optimum results.
The intensity of the test line is directly proportional to the
concentration of hCG in the range of 10-50mIU. Test results may vary
for different individuals depending on the concentration of hCG your
body produces, as well as monitoring frequency, and testing technique.
The best method is to test once a day, at a specific time, by closely
following these test instructions.
PRECAUTIONS
1. For single in vitro diagnostic use only - use test only once for urine screening.
2. Do not use test kit beyond expiry date.
3. Keep away from moisture, direct sunlight, and children.
4. Fruitful Vine is not responsible for your test results. If you get
inconsitent results or think you are pregnant, please see your doctor.
Note: This type of rapid test is used for preliminary qualitative
screening of early pregnancy. It is usually used professionally to
trigger other analytical procedures (blood test, ELISA, etc.) for
quantitative determination of pregnancy conditions. If you suspect that
you are pregnant, or have any concerns on pregnancy, it is recommended
that you see your physician.