Product Description

1. Rapid test for the qualitative detection of SP-10 in human semen.

 2. For self-testing in vitro diagnostic use.

 3. Detection of Acrosomal Protein SP-10 found on sperms to estimate of sperm concentration in human semen above or below 15 million/mL.

 4. Observation of male infertility and provide guidance for reproductive planning of the eligible couples.

Target Group

1. Suitable for eligible couples that have reproductive planning.

Active Ingredient

1. Goat anti-mouse IgG

 2. mouse IgG

 3. anti-SP10 antibody-1

 4. anti-SP10 antibody-2

How to Use

Specimen Collection and Preparation

 1. Before testing, it is important that subject refrains from any sexual activity for 3-7 days. This ensures that the volume and quality of sperm is at its peak and the test will then be an accurate determination of sperm concentration.

 2. Using masturbation, the semen should be collected directly into the sperm collection cup.

 3. Care should be taken that collected semen is not contaminated by touch of hands or tissues or any other materials.

 4. Shake the semen evenly in the semen collection cup and leave it to stand for 1 hour at room temperature until the semen liquefies. Do not use semen after liquefication stored for more than 12 hours.

 Procedure

Before testing, read the instructions carefully and completely. Allow the test, specimen to reach room temperature (15-30°C) prior to testing.

 1. Remove the test cassette from the foil pouch and lay it horizontally on a flat surface.

 2. A semen sample is collected in the collection cup provided.

 3. The sample should then be allowed to stand for 60 minutes, until the semen is fully liquefied.

 4. Using the semen transfer device provided, fill the semen transfer device up to 0.1 mL indicated on the device with the semen sample. The semen sample is then added to the vial of sample dilution buffer provided.

 5. Mix the semen sample and test solution by turning the vial upside down 5-10 times.

 6. Hold the diluted specimen buffer tube upright and open the cap onto the specimen collection tube. Invert the specimen collection tube and transfer 2 full drops of the diluted specimen (approximately 80 μL) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration.

 7. Read results at 5 minutes after dispensing the specimen. Do not read results after 10minutes.

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