US 12,461,093 B2
Method of determining sepsis in the presence of blast flagging
Diana B. Careaga, Miami, FL (US); Robert T. Magari, Cooper City, FL (US); Liliana M. Tejidor, Coral Gables, FL (US); and Nicole Carpio, Tampa, FL (US)
Assigned to Beckman Coulter, Inc., Miami, FL (US)
Filed by Beckman Coulter, Inc., Miami, FL (US)
Filed on May 9, 2024, as Appl. No. 18/659,582.
Application 18/659,582 is a division of application No. 16/390,597, filed on Apr. 22, 2019, granted, now 11,994,514.
Claims priority of provisional application 62/685,753, filed on Jun. 15, 2018.
Prior Publication US 2024/0426813 A1, Dec. 26, 2024
Int. Cl. G01N 33/50 (2006.01); A61B 5/00 (2006.01); G01N 15/01 (2024.01); G01N 15/1031 (2024.01); G01N 15/14 (2024.01); G01N 33/487 (2006.01); G01N 33/49 (2006.01); G01N 33/569 (2006.01); G16H 10/40 (2018.01); G01N 15/06 (2006.01)
CPC G01N 33/5094 (2013.01) [A61B 5/412 (2013.01); G01N 15/1031 (2013.01); G01N 33/48735 (2013.01); G01N 33/49 (2013.01); G01N 33/5091 (2013.01); G01N 33/56972 (2013.01); G16H 10/40 (2018.01); G01N 2015/016 (2024.01); G01N 15/0656 (2013.01); G01N 2015/1402 (2013.01); G01N 2800/26 (2013.01)] 12 Claims
OG exemplary drawing
 
1. An automated system for evaluating a sepsis status associated with a blood sample obtained from an individual, the system comprising:
a cell by cell interrogation module comprising:
a passageway in fluid communication with, and configured to convey cells to, a cell interrogation zone, the cell interrogation zone having a reduced cross sectional area relative to the passageway; and
one or more detectors disposed proximate the interrogation zone and adapted to capture measurements of individual cells as they pass through the interrogation zone in a one by one fashion; and
a data processing module, the data processing module comprising a processor and a tangible non-transitory computer readable medium, the tangible non-transitory computer readable medium programmed with a computer application that, when executed by the processor, causes the processor to:
control cells to pass through the cell interrogation zone;
receive measurements of individual cells from the one or more detectors;
determine a standard deviation of monocyte volume associated with the blood sample based on measurements from the one or more detectors wherein the standard deviation of monocyte volume associated with the blood sample is a standard deviation of volume measurements for individual monocytes in a monocyte population in the blood sample,
determine a value of a blast population characteristic associated with the blood sample based on measurements from the one or more detectors, the blast population characteristic indicating a likelihood of a white blood cell in the blood sample having a blast population statistically different from an expected distribution of white blood cells,
compare the value of the blast population characteristic to a first cutoff value to provide a first comparison;
determine a second cutoff value based on the first comparison;
compare the standard deviation of monocyte volume to the second cutoff value to provide a second comparison; and
evaluate the sepsis status associated with the blood sample based on the second comparison, wherein evaluating the sepsis status comprises determining the sepsis status as a sepsis status from the group consisting of:
the blood sample does not indicate sepsis; and
the blood sample indicates sepsis.