REF:

F2102 (Cassette)

INTENDED USE:

Detector(TM) system SARS-CoV-2 Antigen FIA Test is an immunofluorescence-based lateral flow assay intended for qualitative detection of SARS-CoV-2 Nucleocapsid antigen from human in swab specimens (Anterior Nasal Swab/Nasopharyngeal Swab/Oropharyngeal Swab) and designed for primary detection of SARS-CoV-2 virus for individual who are suspected recent infection.

The test kit is limited for professional use only.

Detector(TM) system SARS-CoV-2 Antigen FIA Test provides preliminary test results, with negative results don’t preclude SARS-CoV-2 infection. The test kit cannot be used as the sole basis for treatment or other management decision.

For in vitro diagnostic use only.

Detector(TM) system SARS-CoV-2 Antigen FIA Test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures and individuals similarly trained in point of care settings.

SUMMARY:

Novel coronavirus pneumonia (Coronavirus disease 19, COVID-19) is an infectious disease caused by SARS-CoV-2 infection. On February 11, 2020 the International Committee for Taxonomy of Viruses (ICTV) renamed the virus SARS-CoV-2.

SARS-CoV-2 has several structural proteins including spike (S), envelope (E), membrane (M) and nucleocapsid (N). The nucleocapsid protein (N) is a conservative protein in coronaviruses, which can provide a relatively stable detection basis for RNA viruses that mutate rapidly. SARS-CoV-2 Antigen FIA Test is specific to SARS-CoV-2 nucleocapsid protein.

Atlas Link Detector(TM) system SARS-CoV-2 Antigen FIA Test is a rapid immunofluorescence assay for the direct detection of the presence or absence SARS-CoV-2 nucleocapsid protein in swab specimens (Anterior Nasal Swab/Nasopharyngeal Swab/Oropharyngeal Swab) taken from individuals who are suspected SARS-CoV-2 infection. The test is intended for interpretation in both laboratory and near patient testing environments only with the Atlas Link Detector(TM) analyzer instrument.

Procedures to evaluate test devices depend on the Atlas Link Detector analyzer workflow configuration chosen. In Direct mode, the instrument evaluates assay devices after manual timing of their development. In Delay mode, devices are inserted immediately after application of the specimen, and timing of assay development and analysis is automated. Additionally, connection of an Atlas Link Detector analyzer to a blue-tooth wireless printer or PC with USB cable is possible if desired. Additional calibration and analysis software is available in PC is also provided.