An ultra-rapid and highly-sensitive chemiluminescence immunoassay for the detection of thyroid stimulating hormone uses water-soluble CdTe QDs as a chemiluminescence reagent and PBS solution of KMnO.sub.4 with specific concentration and pH as an activator to construct a CdTe QDs/KMnO.sub.4 chemiluminescence system of nanoparticle luminescence; based on the semi-automatic test method, the ultra-fast and highly sensitive detection of TSH can reach the level of single molecule detection.

An ultra-rapid and highly-sensitive chemiluminescence immunoassay for the detection of thyroid stimulating hormone uses water-soluble CdTe QDs as a chemiluminescence reagent and PBS solution of KMnO.sub.4 with specific concentration and pH as an activator to construct a CdTe QDs/KMnO.sub.4 chemiluminescence system of nanoparticle luminescence; based on the semi-automatic test method, the ultra-fast and highly sensitive detection of TSH can reach the level of single molecule detection.

Test devices to detect pregnancy in a human female subject are provided. In various embodiment, test devices include an assay means to measure the absolute or relative amount of hCG in a sample from the subject; an assay means to measure the absolute or relative amount of FSH in a sample from the subject; and an assay means to measure the absolute or relative amount of one or more progesterone metabolites in a sample from the subject.

A method of determining the stage (gestation) of a pregnancycomprising the steps of quantifying the amount of the hormone hPL or a fragment thereof in a body fluid sample derived from a human female selected from a blood, plasma, serum and/or urine sample, and establishing the stage of pregnancy corresponding thereto. The disclosure also extends to a device adapted to detect the levels/amount of hPL or a fragment thereof in a body fluid sample, derived from a human female, selected from a blood, plasma, serum and/or urine sample, for establishing the stage of pregnancy.

In one aspect, the inventive concepts disclosed herein are directed to a lateral flow assay comprising: one or more chromatographic substrates, a sample application site, a first capture site, and a second capture site. The first capture site comprising an anti-hCG capture antibody with broad affinity for a group of multiple hCG variants and the second capture site comprising an anti-hCG capture antibody that is specific to a first variant of hCG. Additional aspects of the invention disclose using the later flow assay to determine a ratio of the first variant of hCG to the group of multiple hCG variants.

[Problem] To provide an immunochromatographic test piece containing a control line detection reagent that is not affected by the concentration of an analyte to be detected.

[Means for Solution] An immunochromatographic test piece for quantifying an analyte in a biological sample, the immunochromatographic test piece comprising (a) a conjugation pad impregnated with a detection reagent that specifically binds to the analyte, and a control line detection reagent; and (b) a porous membrane pad on which an antibody for capturing the analyte is immobilized upstream, and an antibody for capturing specifically the control line detection reagent is immobilized downstream.

A reusable test device includes: a wick adapted to collect a fluid to be analyzed; a reusable sensor unit, including: a layer (8) having at least one type of molecular imprinted polymer adapted to bind at least one analyte present in said fluid; and a layer (7) having at least one electrode, wherein said reusable sensor unit is regenerable upon cleansing. The reusable test device further includes a rechargeable electronic unit adapted to read out results from said reusable sensor unit.

An improved electronic diagnostic device for detecting the presence of an analyte in a fluid sample comprises a casing having a display, a test strip mounted in the casing, a processor mounted in the casing, and a first sensor mounted in the casing and operatively coupled to the processor. The processor is configured to receive a signal from the first sensor when the device is exposed to ambient light thereby causing the device to become activated. The device includes a light shield that exerts pressure across a width of the test strip to prevent fluid channeling along the length of the test strip. The processor is configured to present an early positive test result reading when a measured value exceeds a predetermined early reading threshold value at any time after a predetermined early testing time period.

The present invention relates to a method for prognosis of an outcome or assessing the risk of a patient having suffered a stroke or a transient ischemic attack, comprising the determination of the level of at least one marker peptide in said sample said marker peptide selected from the group comprising ANP, AVP, ADM, ET-1, troponin, CRP, calcitonin and hGH or fragments thereof or its precursor or fragments thereof and attributing the level of said at least one marker peptides its precursor or fragments thereof with the prognosis of an outcome or assessing the risk for said patient.

The present invention provides a test device. The device includes a testing element and a house configured to accommodate the testing element, where the house is formed by folding a paper-made card, and the testing element is located in the housing. The housing is allowed to be in different change states to test or assay an analyte in a sample.