COAGULATION
The high-throughput sthemO takes just four minutes on average to first result, making it one of the fastest instruments on the market
new Stago data manager, sthemE Manager, will be able to incorporate new CLIA criteria for APS diagnosis.
The sthemO 301’s enhanced performance is underpinned by new dual technology, combining optical measurement with Stago’s viscosity-based detection system (VBDS), which is unaffected by the presence of haemolysis, icterus and lipaemia (HIL).
into a laboratory’s existing automated sample-handling track. One of its advantages is that it can be installed to fit ‘above’ the track without needing the addition of any linking hardware.
For laboratories with different
throughput requirements or where space for expansion may be restricted, a benchtop model, the sthemO 201, will be available early in 2024. This will offer the same efficiency and analytical performance.
Unique viscosity-based detection and clot wave analysis
Its enhanced performance is underpinned by new dual technology, combining optical measurement with Stago’s unique viscosity-based detection system (VBDS), which is unaffected by the presence of haemolysis, icterus and lipaemia (HIL). The ability to run clotting tests using VBDS and three different wavelengths at the same time will also open up opportunities for new clinical applications.
This emphasis on harnessing the power of technological innovation to develop new assays is reflected across all aspects of Stago’s ‘sthem’ solutions. Another example relates to colorimetric and immuno-turbidimetric assays. The sthemO 301 offers 12 different wavelengths, a unique feature in the coagulation market.
As well as supporting assay
development, this will be used to extend the working range of Stago reagents,
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for example D-Dimer, where diagnostic precision is a critical factor. Further, by expanding immuno-chemiluminescence technology, Stago will be able to automate existing manual enzyme- linked immunosorbent assay (ELISA) kit methods and develop novel tests that demand even greater precision. Stago is also working on improving its anti-phospholipid syndrome algorithm by exploiting the potential of an automated chemiluminescent immunoassay (CLIA) for APS diagnosis. Interpretation of routine tests alongside the lupus anticoagulant (LAC) pathway are already part of the algorithm. The
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Fig 1. An illustration of the dual technology kinetics available on the sthemO instrument lines. The green trace denotes mechanical measurement with yellow, blue and mauve traces indicating optical measurement at three separate wavelengths.
SEPTEMBER 2023
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Evaluations note analytical performance Numerous multicentre evaluation studies are being carried out in the UK and Europe on the new sthemO 301 analyser, with some early findings already presented as posters, including at the recent International Society on Thrombosis and Haemostasis ISTH 2023 Congress.
“Analytical results obtained from one published European evaluation were regarded as being so impressive,” says Mr Querel, “that they have helped us set a benchmark for inclusion of the new system into the test laboratory’s existing workflow.”1 As routine assays are already available for the new system, studies have therefore focused on evaluating the accuracy of PT, APTT, TT, Fib, PC clotting, PC chromogenic, and VWF:Ag assays when run on the sthemO 301. However, the next
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