HAEMOSTASIS AND THROMBOSIS
has been during the last 15 months of COVID. Gateshead reports that requests for specialist D-dimer testing were up by 6.3% in the 12 months from April 2020 to the end of March this year, in comparison to an overall 20% decrease in testing activity during the same period. “The diagnostic importance of this assay has come into its own during COVID, with rising levels seen as a potential indicator of poor outcomes for patients with the virus,” he added. “The laboratory had to quickly gear up to handle the increased demand, with Stago stepping in with support to keep our workflow running smoothly.”
Benefit of ExpertCor fresh frozen plasmas Mr Sudlow continued: “The company always places emphasis on diagnostic innovation, sharing new ideas with us. For example, Gateshead was one of the first laboratories to incorporate Stago’s ExpertCor standardised fresh frozen plasmas into our compliance protocols. They speed up method performance testing across the network and make it easier to demonstrate compliance to UKAS.”
ExpertCor complies with the standards BS EN ISO 15189:2012 and CLSI EP31-A- IR, which require method performance specifications to be verified for each test, instrument and reagent lot. Each kit contains samples with values across the whole working range of common coagulation parameters (prothrombin time [PT], international normalised ratio [INR], activated partial thromboplastin time [APTT], fibrinogen, D-dimer, unfractionated heparin [UFH] and low molecular weight heparin [LMWH]), enabling a laboratory to quickly generate data and statistics to confirm test performance. They can be used on any manufacturer’s coagulation system. The kits are provided with predefined characteristics and have sufficient volume to complete analysis on two instruments, which is ideal for the twin-system set-up at South of Tyne. Gateshead uses three out of the four ExpertCor sets – Routine, D-dimer and LMWH. The fourth kit is for UFH.
Gateshead staff no longer spend time trying to find and select suitable patient samples in sufficient quantities to enable them to be supplied to each laboratory for test comparison. “Comparing test performance has become far more straightforward since we switched to using pre-prepared kits,” said Nicola Keepin, acting haematology departmental manager. “We’ve saved time, with greater confidence in the consistency and quality of our results.”
9 Example of the STA R Max series
Stago tools aid compliance and efficiency
ExpertCor is just one example of Stago’s comprehensive tools that not only improve workflow but aid compliance. Gateshead is in the final stages of moving all the systems onto the Stago
Coag.One middleware and expects this to go live within the next six months. This will enable greater connectivity for measuring instrument trueness across all sites and simplify their external and internal quality control compliance requirements. “
Coag.One will take the laboratory to the next level of efficiency, establishing fast-track cross-site connectivity and oversight of all our STA R Max systems,” said Mr Sudlow. The South of Tyne network has long been running Stago’s STA Coag Expert for autoverification and QC management system – a feature standardised across all instruments. Coag Expert rules reduce the need for manual intervention by automatically managing and prioritising short turnaround time (STAT) samples to ensure a TAT of less than 10 minutes. Further, by providing automated reference range calculations, the rules will determine re-runs, reflex testing and
add-on tests. The software carries out automatic lot-to-lot acceptance testing to confirm reagent reproducibility. As Mrs Keepin confirmed: “The
software monitors our overall performance, enabling the network to manage targets for delivering patient results. The tools also allow the laboratory to carry out the essential measurement of uncertainty calculations needed for accreditation and quality control compliance.” Stago’s international external quality assessment (EQA) programme, My Qualiris QC, is another important aspect of the laboratory’s overall quality solutions. The South of Tyne network values the flexibility, frequency of testing and clinical range of the samples that Stago provides to enable the laboratory to monitor the performance of its specialist coagulation assays. In addition, the regular Diagnostic Challenge (Stago sends out three a year) simulates actual clinical scenarios, which is useful for staff education and training. “Stago is committed to sharing the
burden of compliance with customers, devising standardised systems to make it easier and quicker,” stressed Gillian Eyre, Stago’s sales and marketing manager. “We do that by offering innovative tools such as
Coag.One to achieve far greater connectivity and enhanced confidence in results.”
The cap-piecing technology at the heart of the STA R Max systems.
Solution for HIL interferences Another stand-out feature is Stago’s instrument technology for determining accurate clotting time – a process than can be adversely affected by haemolysis, icterus and lipaemia (HIL) interferences. Many manufacturers rely on optical detection technologies, with varying degrees of susceptibility to HIL
AUGUST 2021
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