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


  • 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
Accord to German law in-vitro diagnostic product can only sell to professionals at moment (12th February 2021). 
Hangzhou Clongene already apply for a special permit in Germany for the use for layperson.