Beckman Coulter Diagnostics DxN VERIS Molecular Diagnostics System: Positive Trial Results Reported

Beckman Coulter has announced the results of recently commissioned independent trials of the new DxN VERIS Molecular Diagnostics System which showed enhanced workflow and productivity over incumbent systems.

A UK trial was undertaken within The Department of Virology at Sheffield Teaching Hospitals NHS Foundation Trust, whose annual automated workload is approximately 105,000 serology samples (more than 300,000 tests) and 65,000 samples for molecular testing (around 129,000 tests), as well as 60,000 samples for Chlamydia and Gonorrhea testing.

“In the last year, the department’s total workload has grown by 57% and the Hepatitis B virus (HBV) viral load workload alone has increased by over 500%. At the same time there are demands for new targets and assays, with a drive to convert from traditional microbiology culture tests to molecular assays”, said Duncan Whittaker, Laboratory Manager Virology. “In addition to this expanding workload, there is also pressure to offer services 7 days per week without additional funding, increasing competition from other private and public laboratories and, peculiar to Sheffield, unprecedented staffing issues resulting in the loss of experienced staff. In effect, the laboratory has to achieve more with less, making workflow improvements and efficient use of staff, time and resources essential if service improvement objectives and user expectations are to be met.

“The Beckman Coulter DxN VERIS Molecular Diagnostics System promised to offer workflow advantages for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV-1) and Cytomegalovirus (CMV). Together, these particular viral load assays represent a significant proportion of the laboratory’s total workload.

“DxN VERIS consolidates DNA extraction, amplification and detection within a single automated instrument. By reducing manual intervention, and automating the steps from sample loading to reporting of results, this system has the potential to revolutionize laboratory workflows and reduce time to results”, Whittaker continued.

Prior to the DxN VERIS evaluation, three different methods were used for HBV, HCV, HIV-1 and CMV viral load assays at Sheffield, with separate extraction and amplification platforms for each. These methods had instrumentation in at least two, and up to four different rooms, depending on the assay, and involved a large number of manual steps and consumables. The requirement for staff to move between rooms is inefficient and the need to take samples off the extraction platform manually and load them on to the amplification system also requires valuable staff time.

The DxN VERIS assays are supplied in a unique single cartridge system, which saves further time and effort. All the consumables and reagents required are on-board, which reduces set-up time and, unlike traditional batch-plate systems, there are no empty wells, which reduces wastage and consumable costs. With true single sample random access and short assay runtimes (as little as 70 minutes to first result), the DxN VERIS platform allows viral load assays to be performed as soon as they arrive in the laboratory, potentially ensuring faster turnaround times (TAT). By comparison, the DxN VERIS Molecular Diagnostics System is a much simpler process, involving fewer steps and consumables. In addition, since extraction, amplification and detection are consolidated onto a single automated platform, there is no need to move between rooms or to stand over the system to transfer samples between functions.

“Hands on time requirements were measured specifically for the HIV-1 and CMV assays. If these two assays alone were consolidated onto the DxN VERIS it would save around 2 hours manual time per day. If all four parameters were consolidated onto the DxN VERIS system, it is estimated that this would ultimately save at least 0.6 whole time equivalent (WTE) biomedical scientists”, said Whittaker.

An independent time/workflow analysis study was performed by Nexus Global Solutions (Plano, Texas, USA), comparing the workflows and time to results between the existing platforms and the DxN VERIS for HBV, HCV, HIV and CMV. DxN VERIS samples were run as single sample random access which meant that, even if samples arrived in the late afternoon, they could be loaded straight on to the system, which is much faster than daily batch testing. Analysis of complexity of use determined that existing methods required 29 or 30 steps, whereas the DxN VERIS methods required only 11 steps

In conclusion, Whittaker commented “Following the workflow analysis study, the improved workflow and time savings that can be achieved using the DxN VERIS could have an enormous impact on the challenges faced by the laboratory. The reduced manual intervention required for DxN VERIS would allow more work to be performed per member of staff. The more efficient workflow would free staff to perform other tasks, which would allow us to develop new services and further increase the department’s test repertoire. This, and improved turnaround times, would help us to remain competitive in an increasingly competitive environment.”