Diasorin Launches LIAISON IQ POC Reader with 10-Minute SARS-CoV-2 Antibody Test
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By LabMedica International staff writers Posted on 22 Apr 2021 |
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Image: LIAISON IQ POC Reader (Photo courtesy of DiaSorin)
DiaSorin (Saluggia, Italy) has launched the LIAISON IQ, its new immunodiagnostic Point-of-Care (POC) reader, and the LIAISON QuickDetect COVID TrimericS Ab test, developed with Lumos Diagnostics (Sarasota, FL, USA) in countries accepting the CE Mark.
This first test available on the LIAISON IQ detects specific IgG antibodies against SARS-CoV-2 spike protein in human capillary blood from a finger stick in 10 minutes. In clinical studies, the test showed a specificity of 97.5% and a sensitivity of 98.0%. The test, which utilizes the full-length trimeric form of the SARS-CoV-2 spike protein already in use in the recently launched LIAISON SARS-CoV-2 TrimericS IgG assay, will be an important tool to establish if a patient has had an adaptive immune response to COVID-19 triggered by either a natural infection or by a vaccine.
DiaSorin intends to access this new market starting with a dedicated program in Italy, targeting pharmacies through agreements with distributors to foster capillary placements of the new combined offer of the platform and the antibody assay. Patients will be able to be tested directly in the pharmacies, with a quick time-to-result solution to detect immune response to SARS-CoV-2 with laboratory-setting quality.
The LIAISON IQ and the LIAISON Quick Detect COVID IgG Ab will also be available in the US market following the US Food and Drug Administration (FDA) Authorization. DiaSorin, together with Lumos, is also pursuing the development of a SARS-CoV-2 Antigen test to be CE marked and submitted to US FDA for Emergency Use Authorization (EUA) within Q2 2021.
“The CE Marking of our LIAISON IQ and its first test provide us access to the growing lateral flow business in the Point-of-care market, allowing DiaSorin to follow the decentralization trend of diagnostics,” said Carlo Rosa, CEO of DiaSorin Group. “This is the right timing for entering the immunodiagnostics Point-of-Care business, with a breakthrough lab-quality solution that uses our biological raw materials in a new, nearer-to-patients context. Our decentralized setting IgG test is the perfect solution to check vaccine efficacy, which is a very relevant information in the current context of the pandemic.”
Related Links:
DiaSorin
Lumos Diagnostics
This first test available on the LIAISON IQ detects specific IgG antibodies against SARS-CoV-2 spike protein in human capillary blood from a finger stick in 10 minutes. In clinical studies, the test showed a specificity of 97.5% and a sensitivity of 98.0%. The test, which utilizes the full-length trimeric form of the SARS-CoV-2 spike protein already in use in the recently launched LIAISON SARS-CoV-2 TrimericS IgG assay, will be an important tool to establish if a patient has had an adaptive immune response to COVID-19 triggered by either a natural infection or by a vaccine.
DiaSorin intends to access this new market starting with a dedicated program in Italy, targeting pharmacies through agreements with distributors to foster capillary placements of the new combined offer of the platform and the antibody assay. Patients will be able to be tested directly in the pharmacies, with a quick time-to-result solution to detect immune response to SARS-CoV-2 with laboratory-setting quality.
The LIAISON IQ and the LIAISON Quick Detect COVID IgG Ab will also be available in the US market following the US Food and Drug Administration (FDA) Authorization. DiaSorin, together with Lumos, is also pursuing the development of a SARS-CoV-2 Antigen test to be CE marked and submitted to US FDA for Emergency Use Authorization (EUA) within Q2 2021.
“The CE Marking of our LIAISON IQ and its first test provide us access to the growing lateral flow business in the Point-of-care market, allowing DiaSorin to follow the decentralization trend of diagnostics,” said Carlo Rosa, CEO of DiaSorin Group. “This is the right timing for entering the immunodiagnostics Point-of-Care business, with a breakthrough lab-quality solution that uses our biological raw materials in a new, nearer-to-patients context. Our decentralized setting IgG test is the perfect solution to check vaccine efficacy, which is a very relevant information in the current context of the pandemic.”
Related Links:
DiaSorin
Lumos Diagnostics
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