Magnetic immuno-chromatographic test paper strip for quantitatively detecting PSA and fPSA in blood and preparation method thereof

Abstract

The invention relates to a magnetic immuno-chromatographic test paper strip for quantitatively detecting PSA and fPSA in blood and a preparation method thereof. A coating film, a magnet particle pad combined with PSA antibodies and rabbit IgG, a sample pad and a water absorbing pad are sequentially and alternately stuck on a base plate in a staggering way at intervals of 2mm, and then the upper layer is covered by a transparent plastic sealing film to form a test paper strip. A total PSA+fPSA antibody detection line and a goat anti-rabbit quality control line are pre-coated on the coating film. The invention introduces the magnetic immuno-chromatographic technology into the quantitative detection of PSA in blood, creatively places total PSA and free PSA on the same test paper strip for simultaneous detection, and has the advantages that the detection sensitivity is improved, the accurate quantitative results of the total PSA and the free PSA can be given, the ratio between the total PSA and the free PSA is clear, and great convenience is provided for clinicians to rapidly and accurately diagnose the illness of patients.

Description

technical field [0001] The invention belongs to the field of medical testing, in particular to a magnetic immunochromatographic test strip for quantitatively detecting PSA and fPSA in blood and a preparation method thereof. Background technique [0002] Prostate-specific antigen (PSA) is a serine protease secreted by human prostate epithelial tissue cells. It is a single-chain glycoprotein molecule with a molecular weight of 30-33KDa, and the encoding gene is located at 19q13. PSA is secreted by the prostate and released into the blood of healthy men at a low concentration. In the human body, it mainly exists in the prostate tissue, semen and serum of men. In the human body, PSA mainly exists in free (fPSA) and bound state (cPSA), and the sum of the two is the total PSA. Free prostate-specific antigen (fPSA) refers to PSA in the free state, which is not combined with α1 antichymotrypsin and the like. When PSA is in the "diagnostic gray zone" (4-10ng / mL), the detection of f...

AI Technical Summary

Problems solved by technology

[0003] The current diagnostic techniques for total PSA+fPSA in blood mainly include: radioimmunoassay (RIA), enzyme-linked immunoassay (ELISA), chemiluminescence (CLIA), time-resolved fluorescence, colloidal gold immunochromatography and other methods, but these methods Each has its own characteristics and shortcomings: radioimmunoassay technology is mature, the results are relatively accurate, and the linear range is wide, but the operation is cumbersome and time-consuming, and the radioactive markers will cause harm to the operator and cause environmental pollution. replaced by other methods

ELISA is similar to chemiluminescence and time-resolved fluorescence method in principle, and only differs in sensitivity. At present, most of them have realized automation, large-scale, quantitative detection, but there are shortcomings such as large difference in results between methods and narrow linear range. In addition, automatic detection Currently monopolized by large foreign manufacturers, the equipment is expensive, and it is not suitable for single-person and small batch testing, which greatly limits their application in primary hospitals and clinics.

In recent years, colloidal gold immunochromatography has emerged to detect total PSA, which is fast, convenient, and single-serve. Due to the limitation of free PSA, it is impossible to detect free PSA, and abnormal samples need to be checked by other methods, which virtually increases the cost of medical treatment for the testees. It is difficult to promote in the market, and it is difficult to use it on a large scale.

Images