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SpermCHECK™
Male Fertility Test
Rapid At Home Male Fertility/Infertility Screening
Test Kit
FDA cleared for home use

A simple, initial screening
test to measure sperm concentration levels in human male semen. The
SpermCHECK™ test determines whether sperm concentration is above or
below 20 million sperm cells per milliliter (million/mL) of specimen
sample, the international cut-off standard established for male
fertility/infertility diagnosis by the World Health Organization
and N.I.H. SpermCHECK™ is a simple, easy
to perform test that can be performed privately at home to check
adequate sperm concentration without the cost and embarrassment of
doctor evaluation. SpermCHECK is FDA cleared for home use. |
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Principle
The
SpermCHECK Male Fertility Test works by
detecting an antigen (a protein compound) found on the surface of the head of a
sperm cell known as SP-10. Research has shown that SP-10 concentrations can be
used to determine sperm count number. To perform the test, you will mix your
semen with a detergent-containing substance, called a buffer, which releases the
SP-10 protein from the sperm. When a few drops of this mixture are added to the
sample well, the SP-10 proteins contained in the mixture bind to a different
protein compound containing colloidal gold. As this newly formed gold-SP10
complex flows through the test membrane, it will cause a reddish line to appear
at the "test line" position in the results window if your sperm count is at
least 20 million sperm per milliliter, indicating that you have a "normal" sperm
count. If your sperm count is lower than 20 million sperm per milliliter, no
reddish line will appear at the test line position. Studies conducted at the
University of Virginia found the SpermCHECK Fertility test to be accurate 96
times out of 100.
Background
Sperm concentration is one of the
primary factors used by physicians to diagnose male infertility. There are many reasons why a man may be
infertile and therefore unable to fertilize the female ovum during reproduction. One
primary and most common reason is an abnormally low production of viable sperm
cells. Other reasons can be over production of inactive, weak, or deformed sperm cells, high levels of other cells in the semen that interfere with fertilization, or other
physiological factors. Medical or physical conditions may also interfere with
normal sperm cell production, including high stress, recent high fever or
illness experienced within two months prior to testing, and abrupt changes in diet.
Taking this initial screening test will indicate if a low amount of sperm
production exists.
Up to 15% of couples experience infertility, which
is defined as the failure to become pregnant after one year of unprotected,
well-timed intercourse. And, in 40% of couples struggling with infertility
issues, male infertility is the primary cause. Because low sperm count is a
leading cause of male infertility, an important first step in determining the
cause of a couple’s infertility issues is to test the man’s sperm count.
However, a trip to a fertility clinic for a semen analysis is not for everyone.
These tests can be expensive (costing hundreds of dollars and not typically
covered by insurance), and are often embarrassing and inconvenient.
Researchers at the University of Virginia developed the FDA-approved SpermCHECK
Fertility in recognition of the need for an affordable and easy-to-use sperm
count test that could be performed at home. A clinical study comparing the
accuracy of SpermCHECK Fertility to standard in-laboratory sperm count methods
showed that SpermCHECK Fertility correctly measures sperm count 96% of the time.
The SpermCHECK Fertility is fast, accurate, affordable and simple to use and
interpret. With SpermCHECK, you will know within minutes if your sperm count is
within “normal” range (above 20 million sperm per milliliter of semen is the
accepted standard for “normal” sperm count). A positive result indicates that
your sperm count is above 20 million sperm per milliliter of semen. A negative
result indicates that the count is below the 20 million sperm per milliliter
threshold, and that further testing by your doctor might be warranted.
SpermCHECK™
Test Components
Each SpermCHECK™ Male Fertility Screening Test Kit contains all the required
materials and reagents to perform one test procedure.
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1 SpermCHECK™ Sealed
Test Cassette
1 Vial Fertility Reagent Test Solution
1 Package Semen Transfer Devices
1 Liquefaction
Collection Cup
1 Complete Test Instruction
Manual |
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Test Procedure:
A semen sample is collected
in the liquefaction cup provided. The sample should be collected within 2-7 days
after the last ejaculation. The sample should then be allowed to stand for
twenty (20) minutes. Using the semen transfer device provided, fill the transfer
device up to the black line indicated on the device with the semen sample. The
semen sample is then added to the vial of fertility reagent test solution
provided. Mix the semen sample and test solution by turning the vial upside down
5-10 times. Let the vial stand for an additional two minutes. Twist off the
Fertility reagent vial cap and add 6 drops of the semen sample solution to the
sample well on the test cassette device marked "S". Read the test results after
7 minutes.
Interpretation of Test Results

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Positive (Fertile) |
Negative (Infertile) |
A
line developing in the
test area (T) and
a line developing in the the control
area (C) of the test
cassette device is a positive test result (sperm concentration is equal to or above 20 million/mL).
The test line may be darker or lighter than the control line. Any line
developing in the test area is a positive test.
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A line developing in the Control area (C)
and no line developing in the test area (T) of the test device is
a negative test result (sperm concentration
below 20 million/mL).Failure of a line developing in
the control region (C) is an invalid test. This occurs primarily when
insufficient sample was added to the sample well.
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Availability
The
SpermCHECK™ Male Fertility Screening Test
has recently been approved for use by the FDA, method and claims, and is now
available to individuals and professionals concerned with male infertility. Each
test kit contains all the components listed above including comprehensive
instructions and reference documentation. The
SpermCHECK™ Male Fertility test kit comes in sales units of
1,3,6 and 12 boxed kits.
Description |
Sale
Unit |
Cost |
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SpermCHECK™ Male Fertility Screening Test
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One (1) Test Kit
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$39.95
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Three (3) Test Kits
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$99.00
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Six (6) Test Kits
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$192.00
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Twelve (12) Tests
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$360.00
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*If
the order buttons are absent or inoperable, please use the
pricing overview page to order. |
For purchases greater than Twelve
(12) kits please contact us by e-mail: Customer Service

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