JOYSBIO SARS-CoV-2 COVID-19 saliva antigen RapidTest kit, using the colloidal gold method, with 100% specificity, 99.22% accuracy and 98.13% sensitivity that gives results within 15 minutes. It consists of a plastic cassette, a place of insertion of the sample, and a buffer.
JOYSBIO SARS-CoV-2 COVID-19 saliva antigen RapidTest kit is easy to use and can quickly and easily deliver results at home, as all the materials needed to perform the test are included in the package.
It has been produced in accordance with the specifications set by the European Commission (Council Directive 98/79 / EC) on In-Vitro diagnostic medical devices (IVDD 98/79/EC Annex III).
It is compatible with the following international standards:
- EN ISO 13485:2016
- EN ISO 14971:2019
- EN ISO 18113-1:2011
- EN ISO 18113-2:2011
- EN ISO 18113-3:2011
- EN 13641:2002
- EN ISO 15223-1:2016
- EN 13612:2002
- EN ISO 23640:2015
- EN 62366-1:2015
The JOYSBIO SARS-CoV-2 COVID-19 saliva antigen RapidTest kit offers results within 15-20 minutes and is suitable for all ages and for people with disabilities. It is individually packaged and stored at a temperature of 2-30°C.
The package contains:
1. 1 cassette/workstation
2. 1 tube with a liquid solution
3. 1 spit funnel
4. 1 tube cap
Instructions for use for the JOYSBIO SARS-CoV-2 COVID-19 saliva antigen RapidTest:
- The JOYSBIO antigen RapidTest can be performed on posterior pharyngeal saliva samples.
- 1. Open the sample collection bag. Clean your throat, loosen the saliva from your throat, and gently spit it into the collection bag.
- 2. Collect the saliva sample with the dropper from the collection bag.
- 3. Unscrew the extraction tube, transfer 3 drops of a saliva sample and discard the excess sample back to the collection bag.
- 4. Tighten the cap and shake the tube well.
- 5. Remove the test device from the case, place it horizontally on a clean, flat surface.
- 6. Remove the cap from the tube nozzle and add 3 drops of treated sample to the cavity of the test cartridge (S) and read the result within 15-20 minutes.
- JOYSBIO SARS-CoV-2 COVID-19 saliva antigen RapidTest kit
- Uses the colloidal gold method
- In accordance with the specifications of the European Commission
- 100% specialization
- 99.22% accuracy
- 98.13% sensitivity
- Suitable for all ages
- For hospitals, medical facilities or home diagnosis
- Shows results in 15-20 minutes
- Individually packaged
- National organization of Medicines number: 2830000634237
- Package of 1 piece