The JOYSBIO Antigen Rapid Detection Diagnostic Test is suitable for the detection of Covid 19 antigen in saliva sample in a quick and easy way, while it has all the necessary certificates from the European Authorities.
No. AEO notification: 42708/11-5-2021
• Clinical sensitivity: 95,00%
• Clinical specialty: 98,78%
• Clinical accuracy: 97.54%
Each package contains:
• 1 test device
• 1 disposable bottle, with 350μL extraction buffer
• 1 sterile, disposable extraction tube with 1 nozzle cap
• 1 sterile, disposable sample collection bag
• 1 disposable dropper
Characteristics
The SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) by Joysbio Biotech has certifications and approvals from many international organizations such as BfArM Germany. Meets the minimum criteria for antigen testing set by the Paul Ehrlich Institute (PEI) in coordination with the Robert Koch Institute (RKI).
• The test is user friendly and all reagents are ready to use.
• It is registered in the German AEO BfArM
• It is registered in the FIND list with a special detailed performance study.
• It has CE-IVD
• The test requires prior study of the instructions for use.
• Specialty and reliability at 100% with a positive prognostic value.
• Fast result within 15-20 minutes.
• It is available in a package of 1 piece.
Orders
The product is not available to retail individuals. For more information contact Mr. Konstantinos Katsamoris tel: 2651085858 or via e-mail at kkatsamoris@newpharm.gr.
*For JOYSBIO Rapid Test in a nasal sample see here: http://www.newpharm.gr/joysbionasal
- Certifications
- Directions for Use