Introduction
2. Generation of Covid-19 Antigen Rapid Test base of saliva.
Some recent studies suggested the role of saliva in the detection of SARS-CoV-2.. As a result, most of studies reported there is no statistically significant difference between nasopharyngeal or oropharyngeal swab and saliva samples regarding viral load.
Clongene has developed the COVID-19 Antigen Rapid Test Cassette (Saliva). The COVID-19 Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in saliva from invididuals who are suspected of COVID-19 by their healthcare provider.
Applicable standards: (source: EC Declaration of Conformity)
EN ISO 13485:2016
EN ISO 23640:2015
EN ISO 18113-1: 2011
EN ISO 18113-2:2011
EN ISO 15223-1:2016
EN ISO 14971:20212
EN 13975:2003
EN 62366-1: 2015
EN 13612:2002/AC:2002
From english product information sheet
20 Tests Box
Composition
- 20 Test Cassettes: each cassette with desiccant in individual foil pouch
- 20 Extraction Reagents: ampoule containing 0.3 mL of extraction reagent
- 20 Saliva Collectors
- 20 Collection tubes
- 20 Droppers
- 1 Work Station
- 1 Package Insert
