Beckman Coulter achieves CE Mark for its MDW-SARS CoV-2 application as an aid in identifying patients with risk of COVID-19

Beckman Coulter announced that its MDW-SARS CoV-2 application has achieved the CE Mark for its MDW application as an aid in identifying adult patients with risk of having SARS-CoV-2 viral infection when presenting to the Accident & Emergency department (A&E).

MDW (Monocyte Distribution Width) is a measure of increased morphological variability of monocytes in response to bacterial, viral, or fungal infections. MDW is an in vitro diagnostic parameter automatically reported as part of Complete Blood Count (CBC) with differential, and is routinely requested in A&E. MDW is the only proprietary, regulatory-cleared hematological biomarker exclusive to Beckman Coulter analyzers that aids in identifying the risk of severe infection and sepsis in adult patients in A&E.

Several influential European studies reported an elevation of MDW in patients diagnosed with COVID-19. These studies have evidenced that MDW is significantly higher in patients with COVID-19 than those without, thus suggesting that upfront MDW measurement while awaiting SARS-CoV-2 molecular results could allow for prompt differential diagnoses in emergency settings. The observations are consistent with the current understanding of COVID-19 as a multi-organ disease resulting from an increased response in circulating pro-inflammatory cytokines through the activity of morphologically differentiated monocytes.

Tommaso Trenti, Director of the Laboratory Medicine Department of the Local Health Unit in Modena, Italy, and investigator in the study published in Nature explains “The morphology of monocytes changes when the activation of the immune system triggers a stimulus, such as in case of bacterial or viral infections. Thanks to the new DxH 900 hematology analyzer for CBC we can measure the nature of these cellular alterations in the lab. I am very pleased that our center was able to contribute towards confirming the role of this new test, which now also has the CE mark approval for IVD devices, which means it can now be used on COVID-19 patients”.

MDW-SARS CoV-2 is a highly sensitive test (87%) with a high NPV (96%). It allows physicians to carry out more accurate risk assessments of COVID-19 for patients for whom RT-PCR data is not available or contradicts clinical presentation, thus enabling better decisions to be made regarding patient disposition in A&E.

“We already considered the MDW results to be a helpful parameter for COVID-19 patients a year ago, also because of its speed and how easily it could be obtained,” said Agostino Ognibene, MD, Director of Laboratory and Transfusion Medicine Department at San Donato Hospital in Arezzo, Italy, and principal investigator in the study published in Clinica Chimica Acta. “The monocyte population is the first element to be involved in the immune response to COVID-19. Such response is the basis of the morphological changes of the monocytes that are reflected in an alteration to the MDW parameter, which can be obtained with a simple CBC. The aggressiveness of the virus and the reactive state of the patient were found to be connected to the MDW parameter, which can therefore be included in patient clinical assessments. Validation of the test gained thanks to it being awarded CE approval for IVD devices is a significant step forwards, confirming the results of the study conducted at our Medical Centre in Arezzo”.

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