Product data
| Category: | Fertility Test |
| Manufacturer: | parahealth |
| SKU: | PD-005 |
| EAN: | 4262408980780 |
| Best before: | 28.02.2027 |
| IFU languages: | ENDEFRITES |
parahealth diagnostics Rapid Test for Male Fertility, Sperm Test Cassette
Benefits:
- Fast results in 15 minutes
- CE certified medical device
- No laboratory required
- High sensitivity and specificity
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Description
Male fertility test – fast, discreet and reliable from the comfort of your home. The parahealth diagnostics sperm test measures the sperm concentration in your semen sample and delivers a clear result in just 5 minutes. Based on the internationally recognized WHO threshold of 15 million sperm/ml, you’ll know whether your sperm count is within the normal range.
Why choose this sperm count test?
- Results in 5 minutes – no lab visit, no doctor’s appointment required
- WHO threshold (15 million/ml) – internationally recognized reference value for normal fertility
- Easy to use – test cassette with illustrated instructions, specifically designed for self-testing
- Discreet at-home testing – neutral packaging, no need to visit a urologist for an initial check
- CE-certified (CE 0123) – approved IVD medical device for in-vitro diagnostics
- Professional-grade quality – same SP-10 antibody technology used in clinical settings
How the fertility test works
The SP-10 rapid test detects acrosomal protein SP-10, which is highly specific to male germ cells. Using an immunochromatographic assay, the test qualitatively determines the sperm concentration in your sample:
- Collect your sample – collect a semen sample in the provided cup and allow it to liquefy for 60 minutes at room temperature.
- Prepare the sample – draw 0.1 ml of semen with the transfer device, add to the dilution buffer and mix well.
- Run the test – apply 2 drops of the diluted sample into the specimen well of the test cassette.
- Read the result – read after 5 minutes. Do not interpret after 10 minutes.
How to read your results
| Result | Display | Meaning |
|---|---|---|
| Normal | Two colored lines (C + T) | Sperm concentration ≥ 15 million/ml – within normal range per WHO |
| Abnormal | One line at C only | Sperm concentration < 15 million/ml – medical evaluation recommended |
| Invalid | No line at C | Repeat test – possible procedural error |
Note: The color intensity of the test line (T) varies depending on SP-10 concentration. Any visible coloration in the test region should be considered a normal result.
Who is this sperm test for?
- Couples trying to conceive – initial screening of male fertility before a full semen analysis at a urologist’s office.
- Men considering or following up on vasectomy – first check of sperm concentration at home.
- Medical practices & fertility clinics – as a point-of-care screening tool before comprehensive semen analysis. Volume discounts available.
- Pharmacies & healthcare retailers – in-demand OTC product in the fertility category. Tiered pricing for your needs.
Kit contents
- 1× SP-10 test cassette
- 1× specimen collection cup
- 1× semen transfer device
- 1× sample dilution buffer
- 1× instructions for use (EN/DE/FR/IT/ES)
Specifications
| Test method | Immunochromatographic rapid test (lateral flow) |
| Target marker | Acrosomal protein SP-10 |
| Cut-off value | 15 million sperm/ml (WHO reference value) |
| Sample type | Human semen (ejaculate) |
| Read time | 5 minutes (max. 10 minutes) |
| Storage | 2–30 °C, do not freeze |
| Certification | CE 0123 – IVD medical device |
| REF | OSP-902H |
| Manufacturer | Hangzhou AllTest Biotech Co., Ltd. |
| EU Authorized Representative | MedNet EC-REP GmbH, Münster, Germany |
Important information
- Abstain from sexual activity for 3–7 days before testing to ensure an accurate result.
- Sperm concentration is one factor in male fertility. Other parameters such as motility and morphology are not assessed by this test.
- If the result is abnormal: repeat the test after 6 days. If the result is abnormal again, consult a urologist.
- For in-vitro diagnostic use only. Not a substitute for a professional semen analysis.
- Keep out of reach of children.
Frequently asked questions
How accurate is an at-home fertility test for men?
The SP-10 rapid test uses the same antibody technology employed in clinical laboratories. It detects acrosomal protein SP-10, which is highly specific to sperm cells. The internationally recognized threshold of 15 million sperm/ml serves as the reference. For a comprehensive assessment of fertility, we recommend an additional semen analysis with a urologist.
How long does the sperm test take?
The actual test procedure takes approximately 5 minutes. Additionally, allow about 60 minutes for the semen sample to liquefy after collection.
What does an abnormal result mean?
An abnormal result indicates that sperm concentration is below 15 million/ml. This does not necessarily mean infertility – other factors such as sperm motility also play a role. Repeat the test after 6 days. If the result is abnormal again, a urological evaluation is recommended.
Can this test be used in medical practices or pharmacies?
Yes. The SP-10 fertility test is a CE-certified IVD medical device suitable for both self-testing and professional use as a screening tool. We offer volume discounts for larger orders.
Parahealth Diagnostics – your specialist retailer for point-of-care diagnostics. CE-certified rapid tests, fast shipping and personal support for clinics, pharmacies and private customers.
Product data
| Category: | Fertility Test |
| Manufacturer: | parahealth |
| SKU: | PD-005 |
| EAN: | 4262408980780 |
| Best before: | 28.02.2027 |
| IFU languages: | ENDEFRITES |
Regulatory notices
- CE-certified in-vitro diagnostic (IVD)
- Intended for self-testing by lay users
- For single use only
- Read instructions carefully before use
- Store at room temperature (2-30 degC)
- Please note that the product you have selected is subject to a limitation of the right of return according to Sec. 312g para. 2 no. 3 BGB. As this product is a medical device, returns are excluded for hygiene reasons.
Sales inquiry / B2B
Interested in bulk orders or reseller pricing? Contact us – we will get back to you as soon as possible.
Or email us directly at sales@parahealth.de
Data sheets & Downloads
Frequently Asked Questions
Find answers to the most common questions about ordering, shipping, and our products.
Are your products clinically tested and safe?
Yes, all our medical devices and diagnostic tests undergo rigorous clinical testing and validation to ensure safety, accuracy, and efficacy. We comply with all relevant medical device regulations and quality standards.
What is your return policy?
We offer a 14-day return policy for private customers. Products must be unused and in original packaging. Please note that B2B and wholesale customers are subject to different terms. Contact our wholesale team for details.
How long does shipping take to Germany?
Standard shipping to Germany takes 1-2 business days from our Berlin facility. We also offer expedited options at checkout for faster delivery.
Do you provide support for professional/clinical use?
Yes, we offer dedicated support for healthcare professionals and clinics, including product training and technical assistance.
What are your B2B payment and shipping terms?
B2B customers receive customized payment terms and shipping arrangements. Please contact our wholesale team for details.
Do you offer bulk orders or wholesale pricing?
Yes, we offer B2B wholesale pricing for pharmacies, clinics, and medical practices. Contact us for volume pricing and terms.
Will I receive tracking information?
Yes, all orders include tracking information sent via email so you can monitor your shipment.
Do you ship internationally?
Yes, we ship worldwide from our Berlin facility. International shipping times vary by destination.
Where do you ship from?
We ship from our state-of-the-art AutoStore Warehouse in Berlin, Germany, ensuring fast and efficient order processing and delivery.