SwimCount FER-T100 Sperm Quality Test Instruction Manual

: June 4, 2024
: SwimCount

Table of Contents

SwimCount FER-T100 Sperm Quality Test
Self test device
Intended purpose
Questions & answers
Performance
Chemical composition
Colour blindness
Contact
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

SwimCount FER-T100 Sperm Quality Test

Self test device

Action window
Result window
Sample well
Slider

Time of use

Take your test during this period
IMPORTANT : Collect your sample at LEAST 2 days, BUT no longer than 7 days after your last ejaculation.
BEFORE TAKING THE TEST, YOU SHOULD:

Read the instructions carefully
Ensure that the contents of the Swim Count™ Box are at room temperature 18-30°C
Check that the contents of the Swim Count™ Box are intact
Have a watch/clock/timer available
For instructions for use, please visit our website: www.myswimcount.co.uk

Collect your sperm sample

Collect your sperm sample in the supplied collection cup.
Make sure that the whole sample is collected. Do not use a condom or lubricant, since this might damage the sperm cells except for the specially developed Swim Count™ Condom.
Leave the sample for 30 min.
It is important that you wait 30 min after producing the sample before you perform the next steps. The waiting time is needed for the sperm sample to liquefy.
Use the syringe to stir the sample 10 times.
Collect exactly 0.5 mL of the sample by using the supplied syringe. It is important to avoid air bubbles inside the syringe, since this will influence the sample volume.

Perform the test

Keep the test device on a horizontal surface throughout the test procedure. Add the sample (0.5 mL) slowly to the sample well marked from the syringe.
Push the slider slowly all the way forward to activate the device. Note: You should hear a ‘click-sound’.
The action window will change to:
Wait another 30 min while keeping the test device on a horizontal surface.
After 30 min pull the slider all the way back as marked by the arrow.
Note: You should hear a ‘click-sound’.
The action window will change to:
The result can be read in the window marked with the symbol shown: The darker the colour the more Progressive Motile Sperm Cells/mL* are present in the semen sample. The test result should be read within 5 min after pulling the slider back. NOTE: Remember to take a picture of your test result taken within 5 minutes if you have any questions. Progressive Motile Sperm Cells = PMSCs

The table below shows what the colour intensity indicates.

Intended purpose

The SwimCount™ Sperm Quality Test is a qualitative test that detects sperm concentration above or below 5,000,000 Progressive Motile Sperm Cells per mL (PMSCs/mL). The test is intended for use as an aid in the determination of a man’s fertility status. For self-test use.
The test kit includes the following components:

Swim Count™ Device
Semen Collection Cup
Syringe
Instructions for use

Questions & answers

How does the test work?
There are two chambers in the device and only PMSCs can move from one chamber into the other. Once in the second chamber the PMSCs are stained with a dye which produces the colour in the result window. The more PMSCs in the semen sample, the stronger the blue colour will be.
There are several factors influencing male fertility. This test is designed to check one of these factors. The test measures the number of swimming (Progressive Motile) Sperm Cells per mL in the semen sample. This is called the concentration of PMSCs/mL. The number of PMSCs is the best predictor of male fertility and a key factor in achieving pregnancy.
A PMSC is the only sperm cell that can fertilize an egg in a natural way. The chance of making a woman pregnant in a natural way increases with the number of PMSCs (up to a certain limit).
My result is LOW, what does this mean and what should I do now?
A LOW result means that the concentration of PMSCs/mL in your semen sample is lower than for fertile men. A LOW result does not necessarily mean that you will be unable to make a woman pregnant in a natural way as sperm quality varies over time. Lifestyle changes may improve the concentration of PMSCs/mL which you can check with further Swim Count™ tests or consult your doctor.
How is NORMAL/LOW defined?
The World Health Organization (WHO) describes a normal level of PMSCs as being more than 5 Million PMSCs/mL1. This means that in a group of fertile men 95% have a concentration of more than 5 Million PMSCs/mL1.
1Cooper et al. Human Reproduction Update 2010; 16(3): 231-245
My result is NORMAL but my partner is not pregnant yet despite several months of trying. What should we do?
One in six couples have difficulties getting pregnant and there are factors other than the number of PMSCs/mL that may affect male fertility. These factors are not assessed with this test. If you and your partner have been trying to get pregnant for 12 months without success, you should see your doctor for further testing and investigation.
I have doubts about my result, what should I do?
If you would like to have a second opinion or an expert advice, you are welcome to contact our helpline at [email protected].
You should always attach a picture of your test result (taken within 5 minutes for a reliable result) in order for us to give you an expert answer on your test result. Remember to note from where you have bought your test and to note the LOT NO and Expiry Date stated on the side of your Swim Count™ Box or on the back of the test device.
You can also test again with a new kit but you should wait at least 48 hours before testing with a new sample.
My sample did not become thin and watery within 30 min. what should I do?
Some samples take more than 30 min to liquefy (to become thin and watery) so you should wait longer if needed. If your sample has not liquefied within 1 hour, then it is better not to test using this sample. Discard your sample, rinse out the collection cup with just water and leave to dry. Do not use soap.
Remember to wait 48 hours before you collect the next sample. If the next sample gives the same result, then consult your doctor.
The test did not seem to work or parts of the test kit were missing or damaged – what should I do?
If any part of the test kit is missing or damaged or if the test did not seem to work, please contact us at [email protected]. Remember to attach a picture of your test device and to note from where you have bought your test and note the LOT NO. and Expiry Date stated on the side of your purchased Swim Count™ box.
For further questions or queries please contact us at [email protected] or visit www.myswimcount.co.uk.
What may affect sperm quality?
There are a number of factors that can affect your sperm quality:
If you have recently (in the last 2-3 months) been unwell particularly if you have had a high fever, this may affect your sperm quality. It is therefore better to wait until you are well before retesting your sperm quality.
If you have been taking anabolic steroids or other medication containing testosterone
Your previous medical history such as:

Undescended testicles as a baby
Varicocele (swollen veins in the testicles)
Groin surgery such as hernia repair
Mumps in adulthood
Treatment for cancer

If you are concerned about any of the above factors, you should consult your doctor who can advise you on the next steps.
Is there anything I can do to improve my sperm quality?
So far there is not much evidence that anything specific can improve your sperm quality but the following may help:

Stop taking anabolic steroids (do not stop taking any prescribed medication without consulting your doctor). Male fertility often returns to normal once use of steroids is discontinued
Take showers instead of hot baths – long hot baths may impact sperm quality
It is always worth taking care of yourself and factors like healthy eating, regular exercise, quit smoking and reducing alcohol consumption will improve your health

What if I want to re-test?
You can test again with a new test kit as long as you wait at least 48 hours after the first test. If you want to see a possible change in your sperm quality after lifestyle changes, you should wait at least three months before testing again. It takes 10-12 weeks for new sperm to be produced so changes in your lifestyle will not materialize before then.

Performance

With a sensitivity of 98% and specificity of 95% SwimCount™ provides an excellent performance for measuring the number of PMSCs per mL.
This means that if the test shows that your sperm have less than 5 million PMSCs per mL., it is 98% likely that the test result is correct. If the test shows that your sperm have more than 5 Million PMSCs per mL, it is 95% likely that the result is correct.

Chemical composition

Swim Count™ contains a chemical for staining the PMSCs consisting of a dye dissolved in a buffered physiological saline solution. The solution is non- toxic.
Interferences
Contamination of the semen sample with urine, red (RBC) and white (WBC) blood cells interfere with the result of the assay.

Colour blindness

Precaution: Colour blindness may impact the ability to correctly read the result.
Important

The test device is disposable and cannot be re-used
Discard with normal household waste
Do not use a device that has expired
This device is for self testing
For in vitro diagnostic use only

Contact

If you have any questions, please contact us at: [email protected] or www.myswimcount.co.uk, www.swimcount.eu, www.swimcount.co.nz, www.swimcount.ie
In case any serious incident has occurred in relation to the device, it shall be reported to the manufacturer and the competent authority of the Member State.