Australian digital diagnostics firm Ellume has extended its strategic partnership with global life sciences and diagnostics company Qiagen.
The partnership has been extended to include a COVID antibody test on the QIAGEN Access platform. The company said the product will serve to address the unprecedented global demand for rapid, accurate diagnostic tests for COVID-19.
The company said Access Anti-SARS-CoV-2 Total is a high-performance serological test that detects antibodies in people who have been exposed to the virus.
The test is run on the Access eHub. It is a portable digital device that provides reliable results in approximately ten minutes. Each device handles up to eight patient samples simultaneously and performs up to 32 total tests per hour. The nanoparticle fluorescent detection technology uses serum or plasma from patient samples.
The company said that in testing submitted to the FDA for Emergency Use Authorisation (EUA) the test had a sensitivity of 100 per cent and specificity of 100 per cent for all samples tested. Positive cases were sampled 14 days after first symptoms.
The test has been submitted for US FDA EUA, with CE-IVD marking anticipated in the coming weeks, it said. QIAGEN has placed a pre-order for 900,000 tests and the first batch of product has been shipped to the company in the US.
“We are pleased to be extending our relationship with our longstanding partners, QIAGEN, in the fight against COVID-19. The Access Anti-SARS-CoV-2 Total test offers a cost-effective COVID-19 testing solution to detect previous exposure to the virus,” said managing director and founder Dr Sean Parsons.
“Increased testing is the only way to gain visibility on the magnitude of the pandemic, which will ultimately lead to helping control it,” said Dr Davide Manissero, chief medical officer at QIAGEN.
“As a trusted partner in the fight against COVID-19, QIAGEN has now added the Access Anti-SARS-CoV-2 to our portfolio as a smart solution for antibody testing that provides results with confidence. This is a rugged and portable platform that requires no hardware, can process a wide range of tests and provides fast results. We look forward to working with Ellume to discover and develop additional tests for this platform.”
The new partnership builds on Ellume’s existing global partnership with QIAGEN on the detection of latent tuberculosis infections.