One Step HCG Urine Pregnancy Test

www.earlypregnancytests4u.co.uk

Early Pregnancy Tests 4U provide two types of dependable early-
detection pregnancy tests: the pregnancy test strip and the midstream
pregnancy test. We also provide Ovulation Tests allowing you to
predict when you ovulate. These also come in both the above types. All
tests comply both to British standards and American FDA standards.

Our tests are upto five times more sensitive than the cheaper versions
sold by high street chemist chains and stores. Thus allowing you to
find out if you are pregnant sooner with the pregnancy tests and to
pinpoint your ideal time to conceive with the ovulation tests.



Our Pregnancy Test Strips are over 99% accurate, and are capable of
detecting human chorionic gonadotropin, or hCG, at levels of just
10mIU/ml/hCG. That means you can begin testing accurately just 6 to 8
days after conceiving.


Ultra Sensitive 10mIU Fastest Pregnancy strip test - CE Marked 0123
INTENDED USE:

FASTEST One Step HCG Urine Pregnancy Test measures the presence of the
hormone Human Chorionic Gonadotrophin (HCG) in your urine for the
early detection of pregnancy.

SUMMARY AND EXPLANATION:

HCG is produced by the placenta during pregnancy, shortly after the
embryo attaches to the uterine lining. Usually HCG can be detected by
a home pregnancy test 7-10 days after conception. The further in to
the pregnancy you are the higher the levels of HCG in your urine.This
pregnancy dip strip detects HCG in urine at a concentration of 10mIU/
ml (MilliInternational Units) or greater. 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 100mlU/ml with
peak levels of 100,000 to 200,000mlU/ml seen at the end of the first
trimester

CONTENTS:

Each pouch contains:

1. One Step HCG Urine Pregnancy Strip Test

2. Desiccant (Discard - Do not eat)

STORAGE AND STABILITY:

The test kit can be stored at room temperature (4 °C to 30 °C) in the
sealed pouch to the date of expiration. The test kits should be kept
away from direct sunlight, moisture and heat.

PRECAUTIONS:

FOR IN -VITRO DIAGNOSITC USE ONLY
Read directions for use carefully before performing this test.
Do not use beyond the expiration date on the foil pouch.
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 opened.
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 test devices as if they are potentially
infectious. Avoid contact with skin.
TEST PROCEDU

1. WHEN CAN I CARRY OUT THE TEST?

You can take this pregnancy test from the first day after a missed
period and onwards.

2. 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.
3. TO CARRY OUT TEST

Bring the test pouch and urine to room temperature. To begin testing,
open the sealed pouch and remove the strip.
Place the test strip vertically (straight) into the urine sample, make
sure the arrows are pointing down. Do not allow the urine level to go
above the MAX (maximum) level line (marked by arrows) on the test
strip.
Remove the strip from the urine after 10 seconds and lay the strip on
a clean, dry surface.
Wait for coloured bands to appear. Depending on the concentration of
HCG in the urine specimen, positive results may be observed in as
short as 40 seconds. However, to confirm a negative result, the
complete reaction time (5 minutes) is required. Do not read results
after 10 minutes.
Discard the test after use.

4. 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.
5. QUALITY CONTROL

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 completely.

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.

PERFORMANCE CHARACTERISTICS:

1. SENSITIVITY

One Step HCG Urine Pregnancy Test will display positive results with
specimens containing HCG at the level close to or greater than 10mlU/
ml.

2. ACCURACY

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%.

PRINCIPLE:

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 fiber 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. In less than 5 minutes,
levels of HCG as low as 25mlU/ml can be detected.

LIMITATION OF THE PROCEDU

1. Alcohol may interfere with the test result. It is not recommended
to use the test after drinking alcohol.

2 .Occasionally urine specimens containing less than 10mlU/ml also
yield positive results.

3.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.

4.HCG levels may remain detectable for several weeks after normal
delivery, delivery by caesarean section, spontaneous abortion or
therapeutic abortion

5.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.

6.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 later.