Arista Covid-19 Antigen Rapid Test

AVAILABLE FOR PROFESSIONAL USE AND SELF-TEST USE

The ARISTA™ COVID-19 Antigen Rapid Test is available for professional use at point-of-care by healthcare providers or personnel trained in any laboratory and non-laboratory environment that meets the requirements; and for self-test use. Both products offer the same reliable technology but differ somewhat in the sample specimen collection procedure. Nasopharyngeal and oropharyngeal specimen collection is only available at point-of-care settings, while anterior nasal and deep throat sputum specimen collection is available for self-test. In all cases, the patient can upload their results to the companion Viva Life App. 

The ARISTA™ COVID-19 Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative in vitro detection of SARS-CoV-2 virus nucleocapsid (N)-protein antigen in humans. The test is intended as an aid in identifying COVID-19 infection and is available for professional use at point-of-care by healthcare providers or personnel trained in any laboratory and non-laboratory environment that meets the requirements, and for self-test use in accordance with local regulations. 

Performance studies conducted on the ARISTA™ COVID-19 Antigen Rapid Test for professional use with nasopharyngeal specimens indicated a sensitivity of 96.3% and a specificity of 99.7% with overall agreement to PCR of 98.8%. 

Performance studies conducted on the ARISTA™ COVID-19 Antigen Rapid Test for self-test use with anterior nasal specimens indicated a sensitivity of 82.6% and a specificity of 99.7% with overall agreement to PCR of 95.2%. 
 
The ARISTA™ COVID-19 Antigen Rapid Test complies with European In-Vitro Diagnostic Devices Directive 98/79/EC, and has been issued HSA Provisional Authorisation (MDPA2020-180) for supply in Singapore and export from Singapore.