US 12,332,242 B2
Method and device for discriminating between viral and bacterial infections
Detlef Jakschies, Hannover (DE)
Assigned to DEWACT LABS GMBH, Berlin-Charlottenburg (DE)
Filed by DEWACT LABS GMBH, Berlin-Charlottenburg (DE)
Filed on Aug. 26, 2022, as Appl. No. 17/897,026.
Application 17/897,026 is a division of application No. 16/766,337, abandoned, previously published as PCT/EP2018/062466, filed on May 15, 2018.
Claims priority of application No. 17203120 (EP), filed on Nov. 22, 2017.
Prior Publication US 2022/0404346 A1, Dec. 22, 2022
Int. Cl. G01N 33/543 (2006.01); G01N 33/569 (2006.01)
CPC G01N 33/54388 (2021.08) [G01N 33/54306 (2013.01); G01N 33/56911 (2013.01); G01N 33/56983 (2013.01); G01N 2333/4715 (2013.01); G01N 2333/4737 (2013.01)] 9 Claims
 
1. A method for discriminating between a bacterial infection and a viral infection in a subject, the method comprising the steps of:
(a) providing a sample from the subject;
(b) providing a point-of-care assay device comprising:
(i) a sample application zone;
(ii) a detection zone with detection reagents consisting of a first detection reagent with binding affinity to Mx-B-protein (Mx-B), a second detection reagent with binding affinity to C-reactive Protein (CRP), a third detection reagent with binding affinity to procalcitonin (PCT), and a fourth detection reagent with binding affinity to bactericidal/permeability-increasing protein (BPI); and
(iii) a test window configured to allow observation of the test results;
(c) applying the sample to the sample application zone of the assay device;
(d) observing the absence or presence of detectable reagent-marker complexes in the test window of the assay device to determine whether the sample contains Mx-B, CRP, PCT, and/or BPI; and
(e) determining the infection status of the subject,
wherein the patient is determined to have a viral infection when (i) Mx-B is present and (ii) CRP, PCT, and BPI are absent;
wherein the patient is determined to have a bacterial infection when (i) Mx-B is absent, (ii) CRP and/or PCT is present, and (iii) BPI is present;
wherein the patient is determined to have a mixed viral and bacterial infection when (i) Mx-B is present and (ii) CRP, PCT, or BPI are present.