US 12,332,252 B2
GFAP accumulating in stroke
Stephen Peter Fitzgerald, Crumlin Antrim (GB); Ivan McConnell, Crumlin Antrim (GB); Ciaran Richardson, Donegal (IE); John Lamont, Crumlin Antrim (GB); and Konstantinos Makris, Athens (GR)
Assigned to Randox Laboratories Ltd., Crumlin (GB); and Randox Teoranta, Donegal (IE)
Appl. No. 16/462,520
Filed by Randox Laboratories Ltd., Antrim (GB); and Randox Teoranta, Donegal (IE)
PCT Filed Nov. 20, 2017, PCT No. PCT/EP2017/079822
§ 371(c)(1), (2) Date May 20, 2019,
PCT Pub. No. WO2018/095872, PCT Pub. Date May 31, 2018.
Claims priority of application No. 1619823 (GB), filed on Nov. 23, 2016.
Prior Publication US 2019/0346458 A1, Nov. 14, 2019
Int. Cl. G01N 33/53 (2006.01); G01N 33/68 (2006.01); G16H 50/30 (2018.01)
CPC G01N 33/6893 (2013.01) [G01N 2800/2871 (2013.01); G16H 50/30 (2018.01)] 4 Claims
 
1. A method for diagnosis and treatment comprising:
(a) obtaining a first biological sample from a suspected pernicious stroke patient at admission, wherein the patient is admitted <6 hours from symptom onset, wherein the biological sample, is blood, serum or plasma;
(b) measuring a first amount of glial fibrillary acidic protein (GFAP) in the first biological sample;
(c) subjecting the patient to a brain CT scan (CT scan) on admission;
(d) diagnosing the patient as having fatal ischemic stroke or hemorrhagic transformation comprising:
(i) identifying the patient as having fatal ischemic stroke when (1) the first amount of GFAP is at least 2-fold higher than a normal control level, wherein the normal control level is the level of GFAP measured in a population of patients comprising non-fatal ischemic stroke patients or a value within a range of 0.140 ng/ml to 0.205 ng/ml, and (2) the CT scan is negative for hemorrhagic stroke, and
(ii) identifying the patient as having non-fatal ischemic stroke undergoing hemorrhagic transformation when the amount of GFAP in the first sample has the normal control level and the CT scan is negative for hemorrhagic stroke at admission, and the method further comprises measuring a second amount of GFAP in a further biological sample taken from said patient at ≥24 hours from admission or symptom onset, wherein a higher level of the second amount of GFAP in the second sample than the first level of GFAP measured in the patient identified as having fatal ischemic stroke of (i), is indicative of hemorrhagic transformation; and
(e) treating the diagnosed patient of (d) comprising administering a therapy, wherein the therapy for the identified patient of (i) is selected from the group consisting of an anti-thrombolytic therapy, anti-coagulative therapy or combination, and the therapy for the patient of (ii) comprises administering surgical repair of a damaged blood vessel.