ALiA

FOR CLINICAL USE

ALiA ® system is an end-to-end solution that delivers multiple results with only one drop of sample in 15 minutes under a Point-Of-Care (POC) setting. The system includes an IVD device and a disposable BioChip. The BioChip is based on a user-friendly microfluidic Lab-On-Chip (LOC) technology to auto-process fluorescent immunoassay on a protein microarray. It enables nurse and physician to process a rapid test in a convenient manner without lab support and provides clinicians a powerful tool for diagnostic decision at front-line. The platform is capable to run a wide range of applications in diseases diagnostics and healthcare management.

Point-Of-Care (POC) refers to “near-patient” areas, for example in the following cases: Within hospital: in emergency units, in acute departments like intensive care units, or other outpatient's’ department. Outside hospital: in institutions, in nursing and care units, in community treatment centres, at clinics in primary health care, in physician’s offices and at patients’ side.

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1

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Load sample into BioChip

2

Insert the BioChip into the tray and enter sample ID

3

Read results and print

INTENDED USE

ALiA® SARS-CoV-2 Antigen FIA Test is a fluorescent immunoassay intended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasopharyngeal swab from individuals who are suspected of COVID-19 infection by their healthcare professionals.

TEST DESCRIPTION

ALiA® SARS-CoV-2 antigen FIA test uses a combination of SARS-CoV-2 viral antigen-specific monoclonal and polyclonal antibodies to determine the presence of SARS-CoV-2 nucleocapsid antigen present in the test sample.

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