SKUP Reports Positive Evaluation of the LumiraDx SARS-CoV-2 Antigen Test in Symptomatic and Asymptomatic Patients
LONDON, UK – January 13, 2021 – LumiraDx, the next generation point-of-care diagnostic company, announced today that the Scandinavian evaluation of laboratory equipment for point of care testing (SKUP) had published a positive evaluation of the LumiraDx SARS-CoV-2 Antigen Test. In a mixed population of symptomatic and asymptomatic subjects tested in point of care settings, the test achieved 87-90% agreement with RT-PCR which increased to 92-95% in patients with viral load corresponding to Ct below 33. A significant body of evidence now suggests that individuals with high Ct values (low viral loads), such as above 33, are likely not infectious. Test specificity was 99.5% in nasal swab specimens.
The LumiraDx SARS-CoV-2 Antigen Test uses Fast Microfluidic Immunofluorescence (FMI) technology to detect antigen nucleocapsid protein from nasal or nasopharyngeal swabs with high sensitivity results in 12 minutes.
“High sensitivity antigen testing at the point of care enables fast and accurate identification of infectious patients” said LumiraDx Chief Innovation Officer Nigel Lindner. “We are pleased with the SKUP results demonstrating high sensitivity and high specificity of the LumiraDx SARS-CoV-2 Antigen Test at Ct values below 33, including in asymptomatic patients, and look forward to working with our partners globally to expand point of care testing.
The SKUP evaluation (trial number SKUP / 2021/124) was conducted in 448 subjects, including 197 who were asymptomatic, and examined both nasal and nasopharyngeal samples. The overall positive agreement of LumiraDx SARS-CoV-2 Antigen Test compared to RT-PCR was 87% in nasal samples and 90% in nasopharyngeal samples. The overall negative agreement of LumiraDx SARS-CoV-2 Antigen Test compared to RT-PCR was 99.5% in nasal samples and 97.8% in nasopharyngeal samples. In patients with viral load corresponding to Ct below 33, the positive agreement was 92% in nasal samples and 95% in nasopharyngeal samples, irrespective of symptoms.
The LumiraDx SARS-CoV-2 Antigen Test is currently commercially available in the US, Europe, Middle East, Africa and Asia Pacific.
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. The LumiraDx SARS-CoV-2 Antigen test is authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
LumiraDx was founded in 2014 by a group of entrepreneurs: Ron Zwanziger, our Chairman and Chief Executive Officer; Dave Scott, Ph.D., our Chief Technology Officer; and Jerry McAleer, Ph.D., our Chief Scientist, who have a successful track record in building and scaling diagnostics businesses over three decades, including at companies such as Medisense, Inc., Inverness Medical Technology Inc. and Alere Inc. The company is supported by institutional and strategic investors including the Bill & Melinda Gates Foundation, Morningside Ventures and U.S. Boston Capital Corporation. Based in the UK and supported by its worldwide affiliates to provide access in all major markets, LumiraDx has over 1000 employees worldwide.
LumiraDx develops, manufactures and commercializes an innovative point-of-care diagnostic Platform. The LumiraDx Platform is designed to deliver lab comparable diagnostic results at the point of care in minutes. It is designed to be affordable and accessible for healthcare providers globally, and to strengthen community-based healthcare.
Further information on LumiraDx and the LumiraDx Platform is available at lumiradx.com.
FOR MORE INFORMATION CONTACT
Media@LumiraDx.com | 920.382.8708