22nd January 2021 Product update: rapidmicrobiology staff writer
Italy, Japan & Brazil Show Confidence in SARS-CoV-2 Microfluidic Rapid Antigen Test
The LumiraDx SARS-CoV-2 Antigen Test is now approved in Japan and Brazil. The rapid test is now available to patients in more than 30 nations worldwide. In addition to these authorizations, the Italian Association for Clinical Microbiology recently published testing guidelines favourable to next-generation microfluidic technology – like LumiraDx's – for COVID-19 testing.
The LumiraDx SARS-CoV-2 Antigen Test is a microfluidic immunofluorescence assay designed to detect SARS-CoV-2 antigen in nasal or nasopharyngeal swab specimens, with high sensitivity results in 12 minutes from sample application.
On January 19th, LumiraDx became the first foreign company to receive approval for its SARS-CoV-2 Antigen Test from Japan's Pharmaceutical and Medical Devices Agency (PMDA). On January 18th, The Brazilian Health Regulatory Agency, or ANVISA (Agência Nacional de Vigilância Sanitária), issued approval for the LumiraDx SARS-CoV-2 Antigen Test.
In order to achieve authorization, LumiraDx conducted several studies and underwent an audit by the regulatory authorities. The company plans to launch shortly in both Japan and Brazil, initially supplying its antigen test to hospitals to help with the current rapid COVID-19 spread.
In further validation of the advantages of the LumiraDx SARS-CoV-2 Antigen Test, the Italian Association for Clinical Microbiology (AMCLI-IT) published new guidelines on January 4th encouraging use of microfluidic technology.*
AMCLI-IT found "antigenic tests with fluorescence reading have better performance (compared to other antigenic tests) and especially those of more recent introduction (immunofluorescence with microfluidic reading) seem to show results superimposable to those of the real-time RT-PCR assay."
Based on the AMCLI-IT position, the Italian Ministry of Health stated that microfluidic antigen tests with fluorescence reading appear to be a valid alternative to RT-PCR, and unlike lateral flow tests, do not require confirmation of a positive result with RT-PCR and may even serve as an alternative confirmatory test to RT-PCR.*
The LumiraDx SARS-CoV-2 Antigen Test is currently commercially available in the US, Europe, Middle East, Africa and Asia Pacific. The LumiraDx Platform – comprised of a small, portable instrument; microfluidic test strip; and secure cloud-based connectivity – provides fast, accurate diagnostic test results to patients in community care settings.
The LumiraDx SARS-CoV-2 Antigen Test is authorized for use by FDA under an Emergency Use Authorization (EUA) only for the detection of SARS-CoV-2 nucleocapsid protein. It has not been authorized for use to detect any other viruses or pathogens.
*If the clinical conditions of the patient show discrepancies with the microfluidic antigen test with fluorescence reading, RT-PCR remains the gold standard for the confirmation of COVID-19.
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Date Published: 22nd January 2021
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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.