SwimCount S07L5C9C2X Self Test Device Instruction Manual

: June 4, 2024
: SwimCount

Table of Contents

Self-test device
Collect your sperm sample
Perform the test
Questions & answers
Performance
Chemical composition
Interferences
Important
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

Instructions for Use

Self-test device

SwimCount S07L5C9C2X Self Test Device - 1

Self-test device

Action window
Result window
Sample well
Slider

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Time of use
IMPORTANT: Collect your sample at LEAST 2 days, BUT no longer than 7 days after your last ejaculation.

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

1. Collect your sperm sample

SwimCount S07L5C9C2X Self Test Device - 3

2. Perform the test

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Examples of results

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BEFORE TAKING THE TEST, YOU SHOULD:

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

Collect your sperm sample

A. 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 damagthe sperm cells except for the specially developed SwimCount™ Condom.
B. Leave the sample for 30 min.
C. 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.
D. 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. OBS: 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. Colour intensity
Male Fertility Status| Concentration of Progressive
Motile Sperm Cells (million/mL)| What does the result mean?
---|---|---
LOW| < 5| Your concentration of PMSCs/mL is below the normal level for fertile men according to the World Health Organisation (WHO)1. Men with a LOW concentration of PMSCs/mL have been shown to have a lower chance of making their partner pregnant in a natural way compared with men with a normal concentration of PMSCs/mL2,3.
NORMAL (Mid)| 20-May| Your concentration of PMSCs/mL is at the NORMAL (Mid) level for fertile men according to the World Health Organisation (WHO)1. Men with a NORMAL (Mid) concentration of PMSCs/mL have been shown to have a good chance of making their partner pregnant in a natural way within 12 months2,3.
NORMAL (High)| > 20| Your concentration of PMSCs/mL is at the NORMAL (High) level for fertile men according to the World Health Organisation (WHO)1. Men with a NORMAL (High) concentration of PMSCs/mL have been shown to have a high chance of making their partner pregnant in a natural way within 12 months2,3.

Questions & answers

How does the test work?****

– There are two chambers in the device and only PMSCs can move from one chamber to 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 SwimCount™ 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 men95% 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 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 re- sult. Remember to note from where you have bought your test, in which country, and to note the LOT NO and Expiry Date stated on the side of your SwimCount™ 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 SwimCount™ box.
– For further questions or queries please contact us at [email protected].

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 the 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 quitting 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 96% and specificity of 91% SwimCount™ provides excellent performance for measuring the number of PMSCs per mL. This means that if the test shows that your sperm has more than 5 million PMSCs per mL., it is 96% likely that the test result is correct. If the test shows that your sperm have less than 5 million PMSCs per mL, it is 91% likely that the result is correct.