US2022155302A1PendingUtilityA1

Lp-PLA2 ASSAYS AND COMPOSITION WITH DETERGENT

Assignee: CLEVELAND HEARTLAB INCPriority: Jan 24, 2017Filed: Jan 31, 2022Published: May 19, 2022
Est. expiryJan 24, 2037(~10.5 yrs left)· nominal 20-yr term from priority
G01N 2800/32G01N 33/573G01N 2333/92G01N 1/28
65
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Claims

Abstract

Provided herein are methods, systems, and compositions for Lp-PLA2 detection assays that employ amounts of detergent to liberate all or nearly all of the Lp-PLA2 molecules from associated lipoprotein particles. In this regard, the true Lp-PLA2 concentration can be detected in a sample, which correlates better with known Lp-PLA2 activity assays.

Claims

exact text as granted — not AI-modified
1 .- 10 . (canceled) 
     
     
         11 . A composition comprising:
 a) a sample, wherein said sample is a plasma, serum, or blood sample, and wherein said sample comprises Lp-PLA2 molecules and lipoprotein particles,   b) a first amount of detergent mixed with said sample, wherein said first amount of detergent is sufficient such that 5% or less of said Lp-PLA2 molecules present in said sample are associated with said lipoprotein particles.   
     
     
         12 . The composition of  claim 11 , further comprising: c) Lp-PLA2 binding molecules. 
     
     
         13 . The composition of  claim 12 , wherein said Lp-PLA2 binding molecules are selected from the group of: aptamers, antibodies, or antigen-binding portions of antibodies. 
     
     
         14 . The composition of  claim 11 , further comprising latex microparticles, and wherein said Lp-PLA2 binding molecules are bound to said latex microparticles. 
     
     
         15 . The composition of  claim 11 , wherein said first amount of detergent is sufficient such that 1-0.1% or less of said Lp-PLA2 molecules present in said sample are associated with said lipoprotein particles. 
     
     
         16 . The composition of  claim 11 , wherein said sample is from a patient suspected of having, or diagnosed with, cardiovascular disease. 
     
     
         17 . A kit or system comprising:
 a) a first amount of detergent mixed with said sample, wherein said first amount of detergent is sufficient such that 5% or less of said Lp-PLA2 molecules present in said sample are associated with said lipoprotein particles; and   b) Lp-PLA2 binding molecules.   
     
     
         18 . The kit or system of  claim 17 , wherein said first amount of detergent is sufficient such that 0.1-1% or less of said Lp-PLA2 molecules present in said sample are associated with said lipoprotein particles. 
     
     
         19 . The kit or system of  claim 17 , wherein said sample is from a patient suspected of having, or diagnosed with, cardiovascular disease. 
     
     
         20 . The kit or system of  claim 17 , further comprising latex microparticles, and wherein said Lp-PLA2 binding molecules are bound to said latex microparticles.

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