ARISTA COVID-19 ANTIGEN RAPID TEST 1S (RTK)

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 99.4% and a specificity of 100% with overall agreement to PCR of 99.82%. 

Performance studies conducted on the ARISTA™ COVID-19 Antigen Rapid Test for self-test use with anterior nasal specimens indicated a sensitivity of 95.8% and a specificity of 100% with overall agreement to PCR of 98.55%. 
Performance studies conducted on the ARISTA™ COVID-19 Antigen Rapid Test for self-test use with deep throat sputum specimens indicated a sensitivity of 97.9% and a specificity of 100.00% with overall agreement to PCR of 99.26%.

Performance studies conducted on the ARISTA™ COVID-19 Antigen Rapid Test for self-test use with saliva specimens indicated a sensitivity of 95.8% and a specificity of 100.00% with overall agreement to PCR of 98.55%.
The ARISTA™ COVID-19 Antigen Rapid Test complies with European In-Vitro Diagnostic Devices Directive 98/79/EC, and was issued HSA Provisional Authorisation (MDPA2020-180) for supply in Singapore and export from Singapore. 

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