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The FertilMARQ™ Home Diagnostic Screening Test Kit for Male Infertility is a rapid test of your semen for sperm concentration. It will measure sperm as either above or below the cutoff of 20 million sperm cells per milliliter (mL). Two test results of less than 20 million cells/mL are an indicator of male infertility.

The FertilMARQ™ Home Diagnostic Screening Test Kit for Male Infertility is an in vitro test kit for the analysis of sperm concentration. Each kit provides sufficient components to perform analysis of two separate semen samples. The kit contains components intended for collection, preparation and testing of semen samples (pre-coated collection cups, disposable droppers, test cassettes), and the reagents to stain and wash semen samples on the test cassette. A package insert that includes a FertilMARQ Sperm Concentration Test Results form is included in the Kit. The Kit and all components are stored at room temperature. The Kit test cassette has four wells and allows the user to perform two separate tests. For each test, there is reference color control well and an adjacent test well provided. There are two sets of reference color wells and adjacent test wells on the cassette.

The FertilMARQ™ Test Kit is a semi-quantitative test for the rapid analysis of sperm concentration to aid in the determination of male infertility.

The FertilMARQ™ Test Kit is an in vitro test kit for the analysis of sperm concentration. Each kit provides sufficient components to perform analysis of two separate semen samples in duplicate. The kit contains components intended to hold, treat, and test collected semen (pre-coated collection cups, disposable pipettes, test cassettes), reagents intended to stain and wash semen samples collected on the test cassette. Positive and negative control wells are incorporated into the cassette design. In addition, the package insert and a Test Results form are included in the Kit. The Kit and all components are stored at room temperature. - The test operates by physical separation of sperm from seminal plasma and other semen components after a sample is dropped onto the filter incorporated into the test cassette. The staining reagent (Thiazine Blue) reacts with multiple components present in the differentiated sperm to provide an average signal that is representative of the entire sperm population. Hundreds of thousands to millions of sperm cells are captured and vield a colorimetric result indicating sperm concentration as above or below 20 million/mL (20 M/mL) sperm, as compared to the negative control result, an intrinsic part of the assay.