US 9,810,699 B2
Risk assessment for antibiotics treatment in patients suffering from primary non-infectious disease by determining the level of procalcitonin
Andreas Bergmann, Berlin (DE); and Joachim Struck, Berlin (DE)
Assigned to B.R.A.H.M.S GMBH, Hennigsdorf (DE)
Filed by B.R.A.H.M.S GmbH, Henningsdorf (DE)
Filed on Mar. 30, 2015, as Appl. No. 14/672,801.
Application 14/672,801 is a continuation of application No. 13/264,252, granted, now 9,046,532, previously published as PCT/EP2010/002279, filed on Apr. 14, 2010.
Claims priority of application No. 09157886 (EP), filed on Apr. 14, 2009.
Prior Publication US 2015/0247871 A1, Sep. 3, 2015
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 2800/32 (2013.01); G01N 2800/325 (2013.01)] 17 Claims
 
1. A method for diagnosing whether a subject suffering from a primary non-infectious disease has an increased risk of an adverse outcome potentially being induced by administration of an antibiotic to said subject, comprising:
(a) detecting and quantifying in a sample of a bodily fluid from the subject the level of Procalcitonin (PCT) consisting of the amino acid sequence 2-116 or 3-116 of the PCT of SEQ ID NO:1, wherein said detection and quantitation comprises
(i) contacting said sample with a diagnostic assay capture molecule which specifically binds to the PCT consisting of the amino acid sequence 2-116 or 3-116 to form a capture molecule:PCT complex and
(ii) quantitating the capture molecule:PCT complex, and thereby determining the level of PCT in the sample;
(b) comparing the thus-determined level of PCT in the sample with a predetermined value for diagnosing of whether the subject has an increased risk of an adverse outcome induced by the administration of an antibiotic,
wherein the predetermined value indicates a statistically significant adverse outcome risk if the sample contains less than 200 pg/mL of PCT, whereby if the sample contains less than 200 pg/mL of PCT, said subject is diagnosed as having a statistically significant increased risk of having an adverse outcome induced by administration of an antibiotic, and whereby treatment with antibiotics is contraindicated, or if the prescribed treatment includes antibiotics, the subject is further monitored for symptoms of an adverse outcome, and
wherein the sample of the bodily fluid of the subject is selected from the group consisting of: a blood sample, a serum sample, a plasma sample, a cerebrospinal fluid sample, a saliva sample, a urine sample and an extract of any of these samples.