US 12,265,092 B2
Workflow for risk assessment and patient management using procalcitonin and midregional-proadrenomedullin
Aline Pehla, Birkenwerder (DE); and Darius Wilson, Berlin (DE)
Assigned to B.R.A.H.M.S GMBH, Hennigsdorf (DE)
Appl. No. 16/956,036
Filed by B.R.A.H.M.S GmbH, Hennigsdorf (DE)
PCT Filed Dec. 20, 2018, PCT No. PCT/EP2018/086150
§ 371(c)(1), (2) Date Jun. 19, 2020,
PCT Pub. No. WO2019/122100, PCT Pub. Date Jun. 27, 2019.
Claims priority of application No. 17209151 (EP), filed on Dec. 20, 2017.
Prior Publication US 2021/0109117 A1, Apr. 15, 2021
This patent is subject to a terminal disclaimer.
Int. Cl. G01N 33/74 (2006.01)
CPC G01N 33/74 (2013.01) [G01N 2333/585 (2013.01); G01N 2800/26 (2013.01); G01N 2800/52 (2013.01)] 8 Claims
 
1. A method of treatment comprising:
(i) preparing a single sample of a bodily fluid from one subject suspected of an infection, or having an infection;
(ii) determining in said sample:
a level of Procalcitonin (PCT) or a fragment or precursor thereof, wherein said fragment or precursor thereof has a length of at least 12 amino acid residues, and
a level of proadrenomedullin (proADM) or a fragment thereof, having a length of at least 12 amino acid residues, and
(iii) determining the severity of the infection of the subject, by comparing said determined PCT level and proADM level, or said level of said fragment(s) or precursors, with threshold levels,
wherein said determined PCT and proADM levels, or said levels of said fragment(s) or precursors, are compared to the PCT and proADM threshold levels of one or more of the following features (iv) to (vi),
(iv) wherein said subject has a determined level for PCT or fragment or precursor thereof is lower than 0.1 ng/ml, and said determined level for proADM or fragment(s) thereof is equal or higher than 0.88 nmol/L, and not equal or higher than 1.5 nmol/L,
or,
(v) wherein said subject has a determined level for PCT or fragment or precursor thereof is lower than 0.1 ng/ml, and said determined level for proADM or fragment(s) thereof is equal or higher than 1.50 nmol/L, and not equal or higher than 2.25 nmol/L,
or,
(vi) wherein said subject has a determined level for PCT or fragment or precursor thereof is lower than 0.1 ng/ml, and said determined level for proADM or fragment(s) thereof is equal or higher than 2.25 nmol/L,
wherein the conditions of at least one of (iv), (v) or (vi) are met, and
if (iv) is applicable, hospitalizing and administering an antibiotic to the subject,
if (v) is applicable, hospitalizing and intravenously administering an antibiotic to the subject, and additionally determining a level of PCT or fragment or precursor thereof within 24 hours, or
if (vi) is applicable, admitting the patient to an intensive care unit (ICU), immediately intravenously administering an antibiotic to the subject and monitoring organ dysfunction of the patient in the ICU.