Rapid test for diagnosis of bacterial infections in neonates
AssigneeImmundiagnostik AG
InventorsFranz-Paul Armbruster, Brigitte Koenig
Life of this patent
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Abstract
The disclosure relates to a point-of-care test device for diagnosis and detection of bacterial infections and hidden septic processes in samples of bodily fluids of premature and newborns comprising a quantitative or semi-quantitative lateral flow immunoassay unit adapted for parallel detection of proteins of the S100 family and for several detection of increased amounts of S100A12 and calprotectin in blood, serum, plasma, and saliva.
Claims12
A method for point-of-care diagnosis and bedside stratification of and septic processes in a blood or serum sample of a neonate, comprising
- diluting a defined amount of sample in a defined amount of buffer having a pH between 5.0 and 5.7, which buffer does not induce an uncontrolled release of proteins from blood cells, granulocytes, monocytes, mast cells or leukocytes and allows for a quantitative flowthrough immunobinding assay of the S100 protein analytes,
- performing one or more flowthrough immunobinding assays at a pH between 5.0 and 5.7 for quantitative or semi-quantitative detection and measurement of at least two proteins of the S100 family of calcium-binding proteins, including at least separate and parallel quantitative or semi-quantitative determinations of S100A12 and calprotectin (S100A8/A9), each yielding an independent measurement result;
- wherein the buffer comprises
- 20-30 g trisodium citrate,
- 2.0-5.0 g citric acid,
- 2.0-5.0 g monobasic sodium phosphate (NaH2PO4),
- and mixed with the blood component in a ratio of about 1:5 to 1:10.
A method of treating neonates suffering from an inflammatory reaction of unknown etiology comprising
- identifying neonates suffering from an inflammatory reaction of unknown etiology by
- mixing a predefined amount of bodily fluid, capillary blood or whole blood with a predefined amount of acidified buffer, having a pH in the range from 5.0 to 5.7 and a functional amount of blood preservative anticoagulant to form an acidified mixture;
- applying predefined amounts of the acidified mixture onto the application zones of one or more lateral flow immunoassays and performing a lateral flow immunochromatography for separate and parallel determination of the presence and content of S100A12 and of calprotectin, each yielding an independent measurement result;
- and
- evaluating the amounts of both S100A12 and calprotectin in the visual zones with the amounts present in samples taken from healthy subjects, where increased amounts of S100A12 and calprotectin are present and indicate the presence of a septic process, and
- treating the identified affected neonates with antibiotics.
Dependencies are inferred from the claim text.