Sepsis Assessment Using MDW Under Blast Flag Interference

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Solution Overview

Problem

Current diagnostic methods for sepsis are inefficient and lack sensitivity and specificity, particularly in patients with blast flags, leading to delayed or inaccurate diagnoses that can be fatal.

Innovation Solution

Utilizing monocyte distribution width (MDW) and white blood cell (WBC) count comparisons with adjusted cutoff values to assess sepsis status, even in the presence of blast flags, through an automated system that evaluates standard deviation of monocyte volume and blast proliferation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If monocyte distribution width (MDW) is used to assess sepsis, then diagnostic sensitivity is improved, but diagnostic accuracy deteriorates in patients with blast flags due to immature cell interference

Engineering Contradiction:
Improvediagnostic sensitivityVSAvoiddiagnostic accuracy
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent applies local quality by implementing different cutoff thresholds for MDW based on the presence or absence of blast flags. When blast flags are present, a higher cutoff threshold is used to account for the interference from immature cells, while when blast flags are absent, a lower cutoff threshold is applied. This localized adjustment of the diagnostic criterion maintains high sensitivity across all patients while ensuring accuracy specifically for those with blast flags.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent changes the parameter threshold dynamically based on the blast flag status. By adjusting the MDW cutoff value according to whether blast flags are present, the system adapts the diagnostic parameter to the specific patient condition, thereby maintaining both sensitivity and accuracy across different patient populations.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If conventional diagnostic testing is performed to confirm infection, then diagnostic accuracy is improved, but time to diagnosis increases leading to delayed treatment

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidtime to diagnosis
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent performs preliminary assessment using MDW and blast flag evaluation before proceeding to conventional confirmatory testing. This preliminary action provides an early indication of sepsis risk, allowing clinicians to initiate empiric treatment or further investigation sooner rather than waiting for the full conventional diagnostic workflow to complete.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent uses a partial diagnostic approach by relying on the combination of MDW and blast flag status as a screening tool rather than requiring complete conventional testing for all patients. This partial action provides sufficient diagnostic information in many cases to guide immediate clinical decisions, reducing the time loss associated with waiting for comprehensive conventional testing results.

Inventive Principle:
Principle #16Partial or excessive action

3Measurement precision

If blast flags are present indicating immature cell proliferation, then cell population detection is improved, but sepsis assessment reliability deteriorates due to elevated baseline MDW

Engineering Contradiction:
Improvecell population detectionVSAvoidsepsis assessment reliability
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent applies local quality by implementing a localized adjustment to the MDW interpretation specifically for patients with blast flags. Rather than discarding MDW data in these patients or applying a universal threshold, the system applies a higher cutoff threshold specifically to the blast flag-positive population, thereby maintaining sepsis assessment reliability while preserving the benefit of MDW measurement.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The blast flag status acts as an intermediary variable that mediates between the MDW measurement and the sepsis diagnosis. By using the blast flag status as an intermediate indicator, the system can adjust the interpretation of MDW values appropriately, allowing the MDW measurement to remain useful while accounting for the confounding effect of immature cell proliferation.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentUS12461093B2Method of determining sepsis in the presence of blast flagging
Publication Date: 2025.11.04 BECKMAN COULTER INC
  • US12461093B2 patent drawing
  • US12461093B2 patent drawing
  • US12461093B2 patent drawing

AI summary

Embodiments of the present disclosure may allow for an efficient and accurate way or system to assess whether an individual has sepsis, including an individual who may exhibit symptoms or clinical criteria similar to inflammation. Embodiments include using a laboratory test that may be routinely ordered. Embodiments of the present invention may allow for the diagnosis of sepsis even when some cells show an abnormal size. Often, when white blood cells show a likelihood of an abnormal size, a “blast flag” in a system is triggered to warn a user that the sample may warrant further analysis. Unexpectedly, the diagnosis of sepsis status using standard deviation of monocyte volume may be more accurate when considering whether a blast flag has been triggered. Based on the sepsis status, treatment may be started quickly, thereby preventing complications, including organ failure and death, of not treating sepsis fast enough.