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.
Disease Rapid Diagnostics
Clinical Decision Support
Infection Outbreak Control
Portable devices
Tracible BioChip
Small sample volume
Automatic test program
Real-time process control
Rapid results in 15 minutes
One test, multiple results
Preloaded reagents
Easy & safe to use
Wide range of applications at one device
1
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.
*The test is limited to laboratories certified to perform high complexity testing, including testing at the point-of-care when the site is covered by the laboratory’s CLIA certificate for high-complexity testing
*ALiA ® detects specific biomarkers via immunoassay from small amount of sample. Please read the user manual thoroughly for correct use. For use under Section IV.C of FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.
Disclaimer:
Support clinical practices at front-line
Technical Features
How to use ALiA®