Procalcitonin detection kit and detection method

Abstract

The invention relates to the field of fluorescence immunochromatography technique in medical immunology, specifically to a procalcitonin detection kit and a procalcitonin detection method. The detection kit is provided with a test cassette and is characterized in that the test cassette is successively provided with, from bottom to top, a PVC plate, a sample pad, a combination pad, a cellulose nitrate film and a water-absorbing pad, wherein a procalcitonin monoclonal antibody labeled by a rare earth fluorescent microsphere is adsorbed on the combination pad, the rare earth fluorescent microsphere has a diameter of 60 to 120 nm, is doped by rare earth lanthanide, is stable in a ground state and emits fluorescent light with a wavelength in a range of 540 to 600 nm under the action of an excitation light source in a wavelength range of 340 to 380 nm, and the monoclonal antibody is a purified mixed monoclonal antibody and is originated from monoclonal antibody cell strains directed at 2 to 6 different procalcitonin antigen epitopes. The procalcitonin detection kit has the advantages of simple operation, rapid reaction, high sensitivity, strong specificity, etc.

Description

technical field [0001] The invention relates to the technical field of fluorescent immunochromatography in medical immunology, in particular to a procalcitonin detection kit and a detection method capable of rapidly and accurately quantitatively analyzing procalcitonin. Background technique [0002] Procalcitonin (PCT) is a glycoprotein composed of 116 amino acids with a molecular weight of 13KD. It is the precursor peptide of calcitonin (CT) and can exist in normal human serum in free form. In 1993, Lancet reported for the first time that the level of procalcitonin was significantly increased in sepsis. When the blood PCT concentration was greater than 0.5ng / ml, it indicated the possibility of sepsis; if it was greater than 2ng / ml, it indicated the existence of sepsis; Sepsis or shock, so PCT can be used as a specific indicator for the diagnosis of sepsis. In recent years, with the deepening of research, it has been found that in the early stage of bacterial infection, th...

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Problems solved by technology

Among them, high-performance liquid chromatography is time-consuming and difficult to automate; ELISA method has poor quantitative accuracy, long operation time, and low degree of automation, and is mostly used for qualitative detection; radioimmunoassay has a sensitivity of 4pg / ml, which can detect normal human serum PCT. The double-antibody sandwich method is sensitive, but the disadvantage is that it takes a long time, the test results are unstable, the repeatability is worse than ELISA, and there is a risk of radioactive contamination; latex particle-enhanced immune turbidimetry (PETIA) can be easily applied and fully automatic biochemical instrument, but the sensitivity is low, and the cut-off value of 0.5ng / ml for procalcitonin diagnosis of systemic infection (sepsis) cannot be accurately detected; the sensitivity of the gold standard method is low, generally only qualitative, not quantitative, especially The shortcoming of poor repeatability limits its clinical application, especially not suitable for the quantitative detection of body fluid marker proteins that need accurate quantification to help diagnose diseases; immunoluminescence method has strong specificity and high sensitivity, but requires Expensive equipment and experienced operators are generally used in specific medical institutions

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