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FertileMARQ™ Male Fertility Test

How does FertilMARQ™ Home Diagnostic Screening Test work?

• The test measures your sperm concentration, and determines whether it is above or below the cut off level of 20 million sperm cells per milliliter (million/ml) of semen. Two test results with sperm concentration below 20 million/ml may indicate infertility.

• The test works by staining the sperm cells in the sample to produce a color. The intensity of the color is compared to a color reference on the FertilMARQ™ cassette. The color comparison will tell you whether the sperm concentration in the test sample is above or below the 20 million/ml cut off point.

Contents of the FertilMARQ Home Diagnostic Screening Test Kit

• 2 Liquefaction cups

• 2 Non-spermicidal condoms

• 1 Resealable foil pouch containing:

o 1 FertilMARQ™ test cassette

o 1 Bottle of blue solution

o 1 Bottle of clear solution

o 2 Plastic droppers

Use a clock or timer to do this test.

All kit materials are non-toxic. If you touch or spill either solution, wipe up with a damp cloth and discard in the regular trash.

The FertilMARQ™ Test Cassette:

• The FertilMARQ™ test cassette contains 4 wells labeled A, B, C and D.

• Reference wells A and C are blue in color. You will compare your test results to the blue color in these reference wells.

• Test wells B and D are white in color. You will place your liquefied semen sample in these test wells.

• The cassette contains enough wells to test 2 separate semen samples.

Important facts about semen collection and preparation

When to collect your semen:

You must wait 3 days after your last ejaculation before you can collect a sample for testing

Semen Sample Preparation:

Freshly ejaculated semen is gel-like in consistency. After approximately 1 hour, the sample thins to a liquid consistency. Only semen that is thinned (liquefied) should be used for testing with the FertilMARQ™ Home Diagnostic Screening Test Kit. The kit contains 2 Liquefaction Cups to make the semen liquefy faster. Please be aware of these important time factors:

• The semen sample must be added to the Liquefaction Cup for at least 15 minutes before testing starts.

• The semen sample in the Liquefaction Cup can be stored for up to 12 hours before you begin testing.

• If the semen sample is not liquefied, the test results may be incorrect.

• If the semen sample has not been tested within 12 hours discard the sample, wait 3 days or more, and obtain a fresh semen sample.

Easy steps for performing the test:

(Wash hands BEFORE and AFTER using the test)

Collect semen: Your semen sample can be collected in any of these 3 ways: • By masturbation directly into the Liquefaction Cup • By masturbation using the condom supplied in the test kit • During intercourse, using one of the supplied condoms in the test kit
			Put semen into the Liquefaction Cup: Avoid touching the inside of the liquefaction cup If a condom was used to collect your semen, transfer the semen from the condom to the Liquefaction cup. • Place a lid on the Liquefaction Cup and swirl gently at least 10 times. • Wait at least 15 minutes but not longer than 12 hours to being testing. • Swirl the Liquefaction Cup before you being testing.
		Open resealable foil pouch: Tear or cut at the notches of the resealable foil pouch. Remove the contents in the pouch. Place the FertilMARQ™ cassette on a flat surface with the wells facing up.
	Draw up the semen: Swirl the Liquefaction Cup before removing the lid Hold and squeeze the plastic dropper at its midpoint. Place the angled tip into the semen sample and release the pressure slowly. Semen will be drawn in the dropper.

					Add the semen to the cassette: Gently squeeze the dropper, and add ONE drop of SEMEN to test well B. • Let the drop soak in for at least 1 minute.
				Add the blue solution to the cassette: Add TWO drops of BLUE solution to test well B. • Let the drops soak in for at least 1 minute.
				Add the clear solution to the cassette: Add TWO drops of CLEAR solution to test well B. • Let the drops soak in for at least 1 minute. • Read the results within 5 minutes.
				Reading the results: Compare the color in the test well B to the color in the reference well A. *Positive Test:* A blue color as dark or darker than the reference color is positive (sperm concentration is less than 20 million/ml). *Negative Test:* A blue color lighter than the reference color is negative (sperm concentration is less than 20 million/ml). *Please note:* If you are performing the second test, you will be comparing the blue color in test well D to the blue color

Note: If no color appears, an error may have been made in adding the SAMPLE or SOLUTIONS. Use the 2^nd test well (D), or obtain another kit if both test wells on the cassette have been used and repeat the test.

Proper storage (between tests):

After completing the 1^st test:

• Return the cassette and solution bottles to the foil pouch.

• Seal the pouch.

• Dispose of the used Liquefaction Cup and dropper.

The second test:

Repeat test at least 3 days but NOT more than 7 days AFTER 1^st test:

• Follow complete instructions, Steps 1-8

• Use Test Well D and Reference Well C.

Disposal: After completion of 2^nd test, dispose of entire kit in the regular trash

Interpreting test results:

First test	Second test	Interpretation
Positive	Positive	Sperm concentration is equal to or greater than 20 million/mL
Negative	Negative	Sperm concentration is less than 20 million/mL. (See your physician)
Positive	Negative	Retest in 10 weeks and consult your physician.
Negative	Negative	Retest in 10 weeks and consult your physician.

• The results of the 2^nd test (performed 3-7 days AFTER the 1^st test) should be the same as the 1^st test.

• If results are NOT the same, wait 10 weeks and repeat the two tests with a new kit

• Once you have your test results, consult your physician.

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NOTE: California Residents - Business and Professions Code 1246.5 Requires That Any Test that has not been approved by the Federal Food and Drug Administration for sale to the public without a prescription as an Over-The-Counter Test kit must be ordered by a Licensed physician acting on a patient's behalf. All orders for test kits within the state of California

NOTE: New York State Residents New York State health law prohibits the testing of certain specimens collected in or mailed from New York, and prohibits the transmission of data from our laboratory to NY physicians or residents. Therefore, direct receipt of lab results for NY residents is not possible.

International Residents & Orders: Extra shipping charges may be added for international orders. Patients will be contacted by e-mail or telephone to approve charges.