Provided is an isolated binding protein including a Taq DNA polymerase antigen-binding domain. The antigen-binding domain includes at least one complementarity determining region selected from CDR-VH1-3 and CDR-VL1-3, or has at least 80% sequence identity with the complementarity determining region and has an affinity of K.sub.D≤8.568×10.sup.−9 mol/L to the Taq DNA polymerase. The binding protein may be used in the field of molecular detection.

The present invention discloses a method for predicting the postoperative risk of brain-injured patients and a use of steroids/proteins for predicting the postoperative risk of brain-injured patients, mainly for testing the concentration of steroids/protein in patient samples. Acquire one-day in-vitro waste cerebrospinal fluid samples from brain-injured patients after surgery and conduct specific steroid and protein concentration tests. By confirming the concentration of specific steroid in the waste cerebrospinal fluid samples or the type and concentration of proteins detected therein, the postoperative risks of brain-injured patients can be predicted.

The present invention relates to a method of identifying a subject being susceptible to a cardiac intervention based on the determination of GDF-15 in a sample of a subject in need of a cardiac intervention. Moreover, the present invention pertains to a method for predicting the risk of mortality or a further acute cardiovascular event for a subject suffering from a cardiovascular complication based on the determination of GDF-15 and a natriuretic peptide and/or a cardiac troponin in a sample the said subject. Also encompassed by the present invention are devices and kits for carrying out the aforementioned methods.

A bi-epitope compound of formula I: ##STR00001##
in which: E1 and E2, identical or different, each separately represents a peptide sequence including at least one epitope of an analyte; X and Y, identical or different, each separately represents a linking arm, the carrier molecule is soluble and Z represents an amino acid derivative bearing a thiol function prior to the bonding of same with the carrier molecule. The compound may be contained in a composition, used as a control or standard in an immunoassay and associated method, and/or provided in a kit for implementing an immunoassay.

The invention provides decision tree based systems and methods for estimating the risk of acute coronary syndrome (ACS) in subjects suspect of having ACS. In particular, systems and methods are provided that employ additive decision tree based algorithms to process a subject's initial cardiac troponin I or T (cTnI or cTnT) concentration, a subject's cTnI or cTnT rate of change, and at least one of the following: the subject's age, the subject's gender, the subject's ECG value, the subject's hematology parameter value, to generate an estimate risk of ACS. Such risk stratification allows, for example, patients to be ruled in or rule out with regard to needing urgent treatment.

The present invention relates to an improved variant monoclonal antibody binding to cardiac troponin T and having a better K.sub.D than the parent monoclonal antibody 11-7

Noninvasive methods of determining breast cancer subtype in a subject are provided that employ newly identified biomarkers. Said methods comprise isolating a population of extracellular vehicles in a biofluid sample of a subject and detecting differential expression in one or more proteins or peptides therein. Such differential expression is compared to one or more expression profiles within a panel of biomarkers, with each expression profile in the panel associated with a subtype of breast cancer. Also provided are kits for detecting a subtype of breast cancer and/or identifying the recurrence thereof, each comprising an antibody, aptamer, or other detection means against the aforesaid biomarkers. Methods for monitoring treatment efficacy in a subject experiencing breast cancer using the same platforms are also provided.

The invention relates to a conjugate comprising a binding element and a self-polymerising biopolymer. The invention also relates to a kit comprising the conjugate and self-polymerising biopolymer subunits. The invention also relates to a method of using the conjugate to measure the concentration of a target substance comprising binding the conjugate to the substance, isolating the bound conjugate, polymerising biopolymer filament, and calculating the concentration of the target substance.

A method of diagnosing breast cancer is disclosed. The method comprises lysing extracellular vesicles of a subject to generate a composition comprising components of extracellular vesicles; measuring the amount of MEK1 in the composition; and diagnosing the subject with breast cancer when a level of said MEK1 in said composition is above a predetermined threshold. Kits for breast cancer diagnosis are also disclosed.

The present invention relates to compositions and methods use in designing immunoassay controls. In various aspects, the invention provides synthetic peptides comprising the sequence CPRRPYIL (SEQ ID NO: 1) or an analog thereof; ELAGLGFAELQC (SEQ ID NO: 4) or an analog thereof; and CDWRKNIDAL (SEQ ID NO: 8) or an analog thereof; specific binding reagents that bind to a CPRRPYIL (SEQ ID NO: 1), ELAGLGFAELQC (SEQ ID NO: 4) or CDWRKNIDAL (SEQ ID NO: 8) peptide; methods of producing such reagents; and assays utilizing such reagents to provide assay controls signals that are unrelated to the measurement of the analyte or analytes of interest in that no reagents used in the analyte assay(s) contribute to the control signal.