



Product data
| Category: | Infectious Disease Rapid Test |
| Manufacturer: | Lysun |
| SKU: | LS-001 |
| EAN: | 6971771200101 |
| Best before: | 31.08.2027 |
| IFU languages: | ENDE |
Lysun Mpox (Monkeypox) Antigen Rapid Test | Blood & Lesion Swab, Result in 15 Min.
Benefits:
- Professional-grade accuracy
- Fast results in 15 minutes
- CE certified medical device
- No laboratory required
- High sensitivity and specificity
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Description
Detect Mpox (monkeypox) reliably – result in 15 minutes. The Lysun Mpox antigen rapid test qualitatively detects monkeypox virus in whole blood, serum, plasma or skin lesion exudate. A CE-certified professional test for rapid point-of-care diagnostics – no laboratory infrastructure required.
Why choose this Mpox rapid test?
- Results in 15 minutes – rapid diagnostics when monkeypox is suspected
- 4 sample types supported – whole blood (fingerstick or venous), serum, plasma and skin lesion exudate
- 100 % sensitivity and specificity – confirmed in clinical validation studies
- Easy to use – lateral flow cassette, no specialized equipment required
- CE-certified – IVD medical device for professional use
- Flexible storage – stable at 4–30 °C, no cold chain required
When is an Mpox antigen test useful?
Mpox typically presents with fever, lymphadenopathy and characteristic skin lesions (vesicles, pustules). The rapid test enables initial diagnostic assessment directly at the point of care – particularly relevant for:
- Patients with suspicious skin lesions and relevant travel or exposure history
- Close contacts of confirmed Mpox cases
- Screening in emergency departments and infectious disease clinics
- Situations where PCR results are not available in a timely manner
Test procedure
From blood, serum or plasma
- Prepare – bring test device, sample and buffer to room temperature (15–30 °C).
- Collect the sample – disinfect the fingertip, prick with a lancet, collect the blood drop with the provided dropper.
- Run the test – apply 1 drop of whole blood (40–50 µl) into the specimen well, then add 1 drop of buffer solution (approx. 3.5–5.8 µl).
- Read the result – after 15 minutes. Do not interpret after 20 minutes.
From skin lesion exudate
- Prepare the cassette – remove the test cassette from the foil pouch and place on a flat surface.
- Collect the sample – insert the disc with filter into the specimen collection tube.
- Run the test – add the extracted solution to the specimen well, apply 3 drops.
- Read the result – after 15 minutes. Do not interpret after 20 minutes.
How to read your results
| Result | Display | Meaning |
|---|---|---|
| Positive | Two lines: C + T | Mpox virus antigen detected. Confirmatory testing (PCR) recommended. |
| Negative | One line: C only | No Mpox antigen detected. Infection not ruled out if clinically suspected. |
| Invalid | No C line | Repeat with a new test kit. |
Note: The color intensity of the test line varies depending on viral load. Even faint lines should be considered positive. Always interpret results in the clinical context.
Who is the Mpox rapid test for?
- Infectious disease clinics & emergency departments – rapid initial diagnostics when monkeypox is suspected.
- General practitioners & dermatologists – point-of-care diagnostics for patients with suspicious skin lesions.
- Public health authorities – screening and contact tracing during Mpox outbreaks.
- STI clinics & sexual health services – accessible testing for at-risk populations.
- Pharmacies with testing services – differentiation in product range. Volume discounts available.
Kit contents (per test)
- 1× test cassette (lateral flow)
- 1× dropper (specimen collection)
- 1× buffer solution
- 1× sterile swab
- 1× instructions for use
Additionally required (not included): timer, specimen collection container.
Specifications
| Test method | Chromatographic immunoassay (lateral flow) |
| Target pathogen | Monkeypox virus (Mpox) |
| Sample types | Whole blood (fingerstick/venous), serum, plasma, skin lesion exudate |
| Read time | 15 minutes (max. 20 minutes) |
| Sensitivity | 100 % |
| Specificity | 100 % |
| Accuracy | 100 % |
| Intended use | Professional use only (not for self-testing) |
| Storage | 4–30 °C, do not freeze, protect from sunlight |
| Certification | CE-certified – IVD medical device |
| Brand | Lysun |
Important information
- For professional use only. Not for self-testing. Must be performed by healthcare professionals.
- The test detects the presence of Mpox virus antigens and should not be used as the sole diagnostic criterion.
- Positive results should be confirmed by PCR.
- A negative result does not rule out Mpox infection – particularly in early stages of infection.
- Handle all specimens as potentially infectious. Follow established precautions for handling infectious materials.
- Humidity and temperature can affect test results.
- Serum/plasma samples can be stored at 2–8 °C for up to 5 days. For longer storage, freeze at −20 °C.
Frequently asked questions
Which sample types can I use?
The test supports four sample types: whole blood (from fingerstick or venous draw), serum, plasma and skin lesion exudate. The lesion swab is particularly informative when visible skin changes are present.
How reliable is the Mpox rapid test?
In the manufacturer’s clinical validation studies, the test achieved 100 % sensitivity, 100 % specificity and 100 % accuracy. Nevertheless, a positive result should be confirmed by PCR testing.
Is the test available for self-testing?
No. The Lysun Mpox antigen test is exclusively approved for professional use by healthcare professionals.
Are volume discounts available?
Yes. We offer tiered pricing for clinics, public health authorities and institutions. Contact us for a customized quote.
Parahealth Diagnostics – your specialist retailer for point-of-care diagnostics. CE-certified rapid tests, fast shipping and personal support for clinics, public health authorities and healthcare professionals.
Product data
| Category: | Infectious Disease Rapid Test |
| Manufacturer: | Lysun |
| SKU: | LS-001 |
| EAN: | 6971771200101 |
| Best before: | 31.08.2027 |
| IFU languages: | ENDE |
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.
