AccuMed 160401 Instructions

One Step Pregnancy Urine Test Strip Instruction Insert
Please read all the information in this Insert before performing
the test.
The One Step Pregnancy Test Strip is an in vitro diagnostic
home use test device intended for the rapid detection of human
chorionic gonadotropin (hCG) in urine to aid in the early
detection of pregnancy. You can easily carry out this test
yourself.
It is intended for over-the-counter (OTC) use.
For in vitro diagnostic use only.
HOW DOES IT WORK?
Human chorionic gonadotropin (hCG) is a hormone, produced
by the developing placenta and secreted into the urine. The
pregnancy test contains antibodies which specifically react with
this hormone. When the sample end of the test is dipped in the
urine specimen, the urine specimen is absorbed by the strip and
migrates along the strip. 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.
A colored line will appear at the Control Zone region if the test
has been performed properly.
CONTENT OF THE TEST KIT
1. One pouch containing a test strip.
2. Insert with instructions for use.
WHAT ELSE DO YOU NEED?
1. A clean, dry, plastic or glass container to collect the urine.
2. Timer or clock.
PRECAUTIONS
1. This kit is for external use only. Do not swallow.
2. Discard after first use. The test strip cannot be used more
than once.
3. Do not use the test after the expiration date printed on the foil
pouch.
4. Do not use the kit if the pouch is punctured or not well sealed.
5. Keep out of the reach of children.
STORAGE AND STABILITY
1. Store at 39° F to 86° F (4º C to 30º C) in the sealed pouch up to
the expiration date.
2. Keep away from direct sunlight, moisture and heat.
3. DO NOT FREEZE.
4. You should perform the test soon after opening the pouch.
You should keep the test in a dry environment before use.
WHEN TO COLLECT URINE FOR THE TEST?
For many women, HCG may be detectable with this test by the
day after the missed period. Any urine specimen will work for
Pregnancy Testing but the first morning urine specimen is
optimal because of its highest concentration of HCG.
HOW TO COLLECT URINE?
Urine specimens may be collected in any clean, dry, plastic or
glass container.
HOW TO DO THE TEST?
1. The test strip and urine have to be at room temperature
59-86º F (15-30° C) for testing.
2. Remove the test strip from the sealed pouch.
3. Immerse the 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 test will not perform correctly.
4. Read results in five minutes. Positive results may sometimes
appear as early as one minute but you should wait the full 5
minutes before determining a negative result. Do not read
results after more than 5 minutes.