FertilMARQ™ Rapid Male Fertility/Infertility Screening Test A simple, initial screening test to measure sperm concentration levels in human male semen. The FertilMARQ™ 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.

Principle

The FertilMARQ™ Male Fertility Screening Test works by staining the cells in the sperm sample to produce a color in a pretreated sample well. The intensity of this color is then compared to a pre-calibrated color reference on the FertilMARQ™ test cassette. The color comparison will identify whether the sperm concentration in the test sample is above 20 million/mL (positive test) or below 20 million/mL (negative test). A sperm concentration below 20 million/mL is clinically indicated as a preliminary diagnosis of male infertility.  Two test results with sperm concentration less than 20 million/mL could result in an inability to conceive reproductively, and should be confirmed through more extensive clinical analysis. See the FertilMARQ™ FAQ.

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. These test results can then be further discussed with a healthcare professional to assist in a more definitive diagnosis of infertility or impotence. Conversely, while a positive test indicates normal sperm production, because of other factors stated above, it is not a guarantee of fertility or successful impregnation. FertilMARQ™ FAQ.

FertilMARQ™ Test Components

Each FertilMARQ™ Male Fertility Screening Test Kit contains all the required materials and reagents to perform two (2) consecutive test procedures. Two tests, both indicating the same test results, are required to confirm overall initial fertility determination.

One (1) FertilMARQ™ Test Cassette (2 tests)   One (1) Bottle of Blue Solution  One (1) Bottle of Clear Solution Two (2) Plastic Droppers Two (2) Liquefaction Cups with lids Two (2) Non-spermicidal Condoms Two (2) Transfer Pipettes Complete Instruction and Reference Manual

Test Procedure

The FertilMARQ™ Test Cassette contains 4 wells labeled A, B, C and D. Reference wells A and C are pre-calibrated with a control blue color. Test results are compared visually and qualitatively  to the blue color in these reference wells. Test wells B and D on the cassette are white in color. These are the two test wells where the liquefied semen samples and reagents are placed for test development. The cassette contains enough wells to test 2 separate semen samples. Test instructions must be followed precisely for accurate results.

Interpretation of Test Results

Positive (Fertile)	Negative (Infertile)
A blue color developing in test well (B) as dark or darker than the control reference color in well (A) is a positive test result (sperm concentration is equal to or above 20 million/mL).	A blue color developing in test well (B) lighter in intensity or color than the control reference color in well (A) is negative test result (sperm concentration below 20 million/mL).

Note: Because test results involve a visual and qualitative evaluation of color intensity or level for correct interpretation and further, because male fertility issues could result in an emotional bias in this evaluation, it is suggested that another individual's opinion of test results may be helpful. This test is a qualitative initial screen for suspected male infertility. No clinical diagnosis of infertility is implied or intended. Results should be confirmed by more analytical methods and consultation with a healthcare professional. 

Availability

The FertilMARQ™ 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.

Description	Sale Unit	Cost
FertilMARQ™ Male Fertility Screening Test	One (1) Test Kit	$39.00
	Three (3) Test Kits	$105.00
	Six (6) Test Kits	$185.00
	Twelve (12) Tests	$330.00
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