Last updated: 01/04/2025

These General Conditions of Service govern the purchase and use of the CYTOfast Urine24 diagnostic kit by private users through the official website www.urine24.com, operated by Hospitex International S.r.l., located at Via Massimo D’Antona 17, 50019 Sesto Fiorentino (FI), VAT No. IT07345680487.

1. Description of Service.

Urine24 is a urinary tract oncology diagnostic service that allows, through a urine self-collection kit, a thin-layer cytological examination, analyzed by qualified health professionals (Medical Anatomo-Pathologist or Cytoscreener), according to The Paris System international medical protocol.

The service includes:

• Urine collection kit with dedicated materials
• Instructions and documentation (patient data form, consents, privacy)
• Collection of samples at home by courier service
• Cytology reporting
• Sending the report by electronic mail

2. Service recipients.

The service is intended for:

• Adults 18 years of age or older who directly purchase and use the kit
• Minors, upon request and written consent from a parent or legal guardian
• Protected persons (not mentally incompetent), subject to authorization by the legal representative

All data of the protected/minor and their respective representative must be indicated in the Patient Data Form and accompanied by copies of the required identity documents.

3. Mode of Purchase

Purchase of the service is made through e-commerce. After payment is completed, the kit is shipped to the address indicated by the user. The price of the service includes: kit supply, customer support, sample pickup, analysis and report sending.

4. Methods of Payment

Payment can be made when ordering through the following secure methods:

• Credit card (Visa, Mastercard, American Express circuits)
• PayPal
• Marking
• Bank Transfer

No other payment methods are accepted.

5. Billing

A valid invoice for tax purposes is not automatic and should therefore be requested at the same time as the order by sending an e-mail to urine24@hospitex.com with the following information:

• Subject: Invoice request for order No. —
• First and last name of applicant
• Tax Code
• Full residential address

Billing requests after the order has been shipped cannot be accommodated.

6. Modes of Use

The patient or guardian must:

• Contact customer service prior to collection to book pickup
• Collect three urine samples on three consecutive days (second morning urination), following the instructions
• Complete the Patient Data Form and sign all required consents
• Pack the bottles and documents as indicated
• Deliver the package to the courier on the agreed date, within 24 hours after the last collection

Caution: Failure to follow instructions or to provide the correct documentation may jeopardize service delivery.

7. Referral

Cytological analysis will be performed by qualified health care personnel (Anatomo Pathologist or Cytoscreener), according to the international criteria of The Paris System. The report is sent by e-mail within approximately 5-8 working days after the specimens are received in the laboratory.

The user may also request, if desired, a hard copy which will be sent by postal service. There is a charge of €20 per shipment for this additional service.

The report has medical-diagnostic value and must be interpreted by a specialist.

8. Right of Withdrawal

Pursuant to Article 59(e) of the Consumer Code (Legislative Decree 206/2005), the right of withdrawal does not apply, as this is a sealed product for sanitary use. However, it is possible to cancel the order before the kit is shipped.

9. Legal Warranty

You are entitled to the legal warranty in case of product defects (Articles 128-135 of the Consumer Code). To activate the warranty, you must keep the order receipt e-mail and the Unique Examination Code (SES) listed on the Patient Data Form.

10. Processing of Personal Data

The processing of personal and health data is done in full compliance with the EU Regulation 2016/679 (GDPR) and current national legislation. Informed consent is mandatory to proceed with the examination.

The electronic report is sent via a secure system.

11. Limitations of Liability

Hospitex is not responsible for:

• Delays due to shipping or collection errors
• Damage caused by improper use of the kit
• Reports altered by noncompliant samples
• Errors or independent interpretation of the report by the patient

The report should always be discussed with a physician.

12. Customer Service

For assistance, contact:

• Phone: +39 055 062 2114 (Mon-Fri, 9:30 a.m.-1:30 p.m.)
• E-mail: urine24@hospitex.com