Beckman Coulter Diagnostics’ Access MeMed BV assay, a test that helps clinicians differentiate between bacterial and viral infections, is now approved under the IVDR.
Beckman Coulter has partnered with MeMed, a leader in advanced host response technologies, to bring the MeMed BV test into core laboratory settings. MeMed’s mission is to transform patient care by interpreting immune system signals and translating host-response data into clinical insights to support clinicians’ decision-making.
Clinicians have published that use of the MeMed BV test has resulted in improved clinical decision-making, helped them to reduce unnecessary antibiotic use, and supported antimicrobial stewardship efforts.
Validated for use across Beckman Coulter’s installed base of DxI 9000 and Access 2 immunoassay analysers, the Access MeMed BV assay enables fast, reliable infection differentiation while leveraging laboratories’ existing infrastructure and workflows.
Confident clinical decisions
Bacterial and viral infections often present with similar symptoms, making early differentiation challenging and increasing the risk of inappropriate patient management or unnecessary antibiotic use. Timely distinction is essential, as treatment decisions are frequently made before traditional diagnostic methods – which can take hours or days – provide definitive results.
Traditional diagnostic approaches typically focus on direct pathogen detection, but this can be slow, unreliable, or inconclusive. These limitations may delay clinical decisions, contribute to antibiotic misuse, and compromise effective infection management.
Conventional tests are often insufficient:
- Inaccessible infection sites
- Often no pathogens are detected
- False alarms due to colonisation
- Prolonged time to results
- Poor performance for emerging pathogens.
How does it work?
Direct from a serum or plasma sample, MeMed BV computationally integrates the levels of three host immune proteins (CRP, IP-10, and TRAIL) into a simple score indicating the likelihood of a bacterial immune response or co infection versus a likely viral immune response (or other non-bacterial aetiology).
Powered by machine learning and these three host-response biomarkers – TRAIL, IP-10, and CRP – a powerful algorithm turns host protein levels into one easy-to read score; helping clinicians act fast, with confidence and precision.
Utilising existing infrastructure
The Access MeMed BV assay is available on Beckman Coulter’s DxI 9000 and Access 2 immunoassay analysers. It utilises existing laboratory infrastructure to provide differentiation between bacterial and viral infections, with results available in approximately 15 minutes on the DxI 9000 and about 22 minutes on the Access 2. The assay supports timely, evidence-based clinical decision-making and integrates into standard laboratory workflows to deliver rapid and reliable results.
Reflecting on the clinical and operational impact, Melissa Naiman, Senior Director, Medical & Scientific Affairs - Acute Care at Beckman Coulter Diagnostics, noted that: “By delivering rapid, highly reliable bacterial and viral differentiation on routine immunoassay systems, we’re empowering care teams with the timely insights they need to guide appropriate treatment decisions, while optimising laboratory efficiency using existing workflows.”
The broader significance of this approach is echoed by MeMed leadership. Eran Eden, CEO and Co-founder of MeMed, emphasised that: “This collaboration with Beckman Coulter significantly accelerates our mission to make host-response testing available at scale. The MeMed BV test has repeatedly demonstrated its ability to improve clinical decision-making, empower clinicians to reduce unnecessary antibiotic use, and support antimicrobial stewardship. This is backed by robust clinical and real-world evidence, including emerging evidence supporting its value in suspected sepsis management among high-risk patient populations. Making the assay available on high throughput laboratory analysers allows healthcare systems to unlock those benefits for far more patients.”
Consistent accuracy
MeMed BV performance has been validated in multi-national, double-blind clinical studies and real-world settings enrolling more than 20,000 subjects in Europe, Israel and the United States (references available). These studies have consistently demonstrated compelling performance results in different clinical settings, age groups, and patients with different clinical syndromes.
Recent real-world studies across nearly 6,000 adult and paediatric patients found that clinicians face uncertainty about antibiotic prescribing in approximately 16–29% of cases. Following receipt of MeMed BV results, physicians reported that the test supported or changed clinical decision-making in approximately 82–87% of cases. In prior blinded multicentre validation studies, MeMed BV demonstrated up to 99% negative predictive value (NPV) as an aid in excluding bacterial infection.
The growing clinical interest in host response diagnostics is also reflected in recent NHS initiatives in the UK, where NHS England funded a multicentre paediatric trial evaluating rapid MeMed BV testing in emergency departments. Clinicians reported that the 15-minute test supported faster treatment decisions in children with serious conditions including meningitis and sepsis, while also helping reduce unnecessary antibiotic use by providing more rapid information about whether infections were viral or bacterial.
Case study
A woman in her 40s, a healthcare worker, presented to the emergency department at Johns Hopkins Hospital with three days of high fever and body aches. Although her examination and initial workup were not strongly suggestive of severe bacterial infection, the physician ordered a MeMed BV test to support clinical assessment. The test returned a score of 100, indicating a high likelihood of bacterial infection or bacterial co infection.
While discharge was initially being considered, the MeMed BV result prompted the care team to keep the patient for observation. Within one hour, her condition worsened rapidly, progressing to septic shock. Imaging later revealed acute pyelonephritis, and blood and urine cultures subsequently grew Escherichia coli. She was admitted to the ICU, stabilised by day two and discharged home on day three.
As noted by Professor Edana Mann of the Johns Hopkins Hospital Emergency Department, the BV assay provided actionable information that standard laboratories could not, directly altering the patient’s trajectory; without it, the patient might have been discharged prior to her deterioration, delaying recognition of life-threatening sepsis.
- References supplied and are available on request from [email protected].
Beckman Coulter
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