Fujirebio Europe has received CE marking for their Lumipulse G SARS-CoV-2 Ag, a high-sensitivity antigen test for the fully automated CLEIA (chemiluminescent enzyme immunoassay) Lumipulse G system, and of the ESPLINE SARS-CoV-2 rapid antigen test. Fujirebio is a global leader in the field of high-quality in vitro diagnostics (IVD) testing.
The Lumipulse G series are robust, fully automated CLEIA immunoassay instruments. The Lumipulse G1200 and G600II have a throughput of respectively 120 and 60 tests per hour and allow laboratory personnel to randomly load samples as needed. CLEIA technology and automated testing provides increased sensitivity, reproducibility and throughput.
The ESPLINE SARS-CoV-2 is an immunochromatographic rapid antigen test, and unlike other nucleic acid-based tests on the IVD market that also detect the SARS-CoV-2 gene with high sensitivity, the ESPLINE test does not require any special equipment. It is a cassette-style assay using a simple procedure, and it has a short reaction time of 30 min.
Both assays received Japanese regulatory approval in May and June 2020 for use with nasopharyngeal and saliva samples (Lumipulse only) as an aid in the diagnosis of SARS-CoV-2 infection.
“We are the first company to develop and provide a fully automated SARS-CoV-2 antigen testing solution, to be used on our Lumipulse G series, together with a rapid test device on the ESPLINE platform, and expect these innovations will have a positive impact on result turnaround times and laboratory throughput of COVID-19 testing,” said Christiaan De Wilde, CEO at Fujirebio Europe.

• For more information, visit: www.fujirebio.com/en/products-solutions/lumipulser-g-sarscov2-ag

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A rapid new coronavirus test, which provides results for Covid-19 in just 39 minutes, is now available on the Vivalytic, a point-of-care platform brought to market by Randox Laboratories and Bosch.
The test for detection of the SARS-CoV-2 pathogen is currently the fastest PCR test (the gold standard of test methods) worldwide, and is predestined for decentralized use in mobile test centres at service stations or in airports, so that people who take the test can obtain a reliable result while at the testing site.
The CE-approved test is now available in Europe. The test has a sensitivity of 98% and a specificity of 100%.
“This new rapid test will be a game-changer in the coronavirus testing landscape by allowing patients to receive their results at the point of care faster than before,” said Dr. Heather McMillan, Molecular R&D Manager at Randox Biosciences.
Randox and Bosch launched the first rapid test for the Vivalytic analyser at the end of March, after just six weeks’ development.
As a multiplex test, it simultaneously checks samples for the SARS-CoV-2 virus as well as nine other respiratory diseases in two and a half hours, whereas the new accelerated test is exclusively for SARS-CoV-2.
Marc Meier, president of Bosch Healthcare Solutions, cmmented: “With our different coronavirus tests and variable analysis strategies, we open up a range of testing scenarios with a Vivalytic device – from screening all the way to supporting differential diagnosis for similar symptoms.”
Development work for Covid-19 tests on the Vivalytic is ongoing: As of early October 2020, by pooling samples together it will be possible to simultaneously evaluate five samples in one test cartridge and at a comparable speed – a world first.
This will increase available testing capacity by enabling fully automated processing of more than 160 samples a day using a Vivalytic device.
Key benefits
The advantages of the rapid SARS-CoV-2 test on Vivalytic lie not only in speedy analysis, but also in ease of use. A sample is taken from the nose or throat using a swab, and placed in the test cartridge. Then the cartridge, which contains all the reagents required for the test, is inserted into the Vivalytic device for automated analysis.

• Turnaround time of 39 mins from sample entry to result.
• The SARS-CoV-2 rapid test has recently received CE marking.
• The SARS-CoV-2 pooling test can run up to 5 samples on-board a single cartridge.
• Easy 4-step user-friendly process from sample entry to result. Minimal training required.
• Detection from real-time PCR from Nasopharyngeal and/or Oropharyngeal swab.
• Suitable for use in any laboratory and non-laboratory settings.

For more information, email: marketing@randox.com
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Bio-Rad Laboratories, a global leader of life science research and clinical diagnostic products, has introduced StarBright Violet 515 (SBV515) Dye, the first of a new range of unique fluorescent nanoparticles, for use in flow cytometry. Star- Bright Dyes are conjugated to a growing range of antibodies and are compatible with most flow cytometers and experimental protocols.
The StarBright Violet 515 Dye with an excitation maximum at 401 nanometre and emission maximum of 516 nanometre offers researchers improved brightness to resolve rare and low antigen density populations more easily. It has a narrow emission profile to reduce spillover into neighbouring filters and minimal excitation by other lasers, making it suitable for inclusion in multicolour panels.
The dye is not susceptible to photobleaching, delivers high lot-to-lot reproducibility, and is stable at 4°C with no loss of signal to help ensure consistent staining and deliver reliable results. It has been tested in many common staining buffers and there is no requirement to use a special staining buffer, permitting easy integration into common experimental protocols without compromising performance. StarBright Violet 515 Dye is compatible with Bio-Rad’s ZE5 Cell Analyzer, S3e Cell Sorter, as well as other cytometers, and it is suitable for both conventional and spectral flow.
Mike Blundell, Bio-Rad Product Manager, Life Science Group, commented: “StarBright Violet 515 Dye is brighter than other common dyes that emit at similar wavelengths. The dye is flexible enough to fit into any flow cytometry panel, allowing researchers to multiplex with ease regardless of flow cytometer and experimental protocol, and it offers a superior alternative for fluorophores that have emission maxima between 500 and 550 nanometres.”
For more information, visit: www.bio-rad-antibodies.com/starbright
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