In January 2020, the World Health Organisation (WHO) announced the Covid-19 outbreak as a public health emergency of international concern, the highest level of alert. Ever since, the virus has plagued the global population, putting healthcare systems under huge pressure. As Covid-19 spread, timely and accurate diagnostic testing was identified as an essential tool in protecting people and fighting against it.
A key player in the life sciences market, and with a long heritage in developing diagnostic assays for infectious diseases, Bruker was well placed to respond to the urgent needs of medical institutions worldwide, pivoting rapidly to the production of SARS-CoV-2 tests at the start of the pandemic. Over its duration, Bruker has developed a range of assays allowing for the detection and quantification of SARS-CoV- 2. As the virus evolved, so has Bruker’s SARS-CoV-2 portfolio, which covers detection and quantification as well as identification of latest mutations.
An overview of Bruker SARS-CoV-2 assays reads as follows:
■ Detect FluoroType SARS-CoV-2 plus (IVD): launched early in the pandemic to support clinical labs across the world.
FluoroType SARS-CoV-2/Flu/RSV (IVD): developed to simultaneously detect the presence of SARS-CoV-2, influenzas A and B, and respiratory syncytial virus (RSV). This highly multiplexed respiratory assay significantly reduces the testing time compared with individual tests, helping labs prepare for the winter and flu seasons.
■ Quantify and identify mutations FluoroType SARS-CoV-2 varID Q (IVD): following recommendations by the WHO, Bruker launched an assay to identify relevant SARS-CoV-2 mutations as well as quantify the viral load. This is important to help limit the spread of the virus by understanding whether an individual is likely to be infectious.
■ Identify emerging mutations FluoroType SARS-CoV-2 evo (RUO): detects SARS-CoV-2 and simultaneously differentiates four different S-gene mutations to help identify variants and track their spread.
From extraction to result Interpretation
Bruker’s efforts around hardware, software and assays have led to a fully validated, integrated workflow for rapid laboratory set-up and high-throughput testing. The workflow provides certainty in every step of the SARS-CoV-2 testing process, from extraction with the GenoXtract fleXT to polymerase chain reaction (PCR) analysis in the FluoroCycler XT. After a short software-guided set up, sample material enters the GenoXtract fleXT. PCR plates ready for analysis in the FluoroCycler XT are prepared automatically by the instrument.
For traceability, the samples are automatically tracked from the GenoXtract fleXT to the FluoroCycler XT by barcode scanning and laboratory information management systems (LIMS). The FluoroCycler XT’s highly controlled, fully automated internal environment maintains a homogenous temperature across the entire plate, ensuring accuracy of results. For multiplexing, the instrument has been equipped with five detection channels, which enable the parallel analysis of up to 96 samples, thereby supporting high-throughput SARS-CoV-2 detection.
The FluoroSoftware XT-IVD provides instant results tracked via LIMS. For example, the software clearly shows the presence or absence of the virus in a simple graphic accompanied by a short interpretation text. In the case of the FluoroType SARS-CoV-2 varID Q assay, the viral load quantification in international units per ml is displayed without further need for result conversion or manual interpretation of PCR results.
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