Magnetic immuno-chromatographic test paper strip for quantitatively detecting tumor associated antigen 15-3 in blood and preparation method thereof

Abstract

The invention relates to a magnetic immuno-chromatographic test paper strip for quantitatively detecting tumor associated antigen 15-3 in blood and a preparation method thereof. A coating film, a magnet particle pad combined with tumor associated antigen 15-3 antibodies, 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 tumor associated antigen 15-3 antibody detection line and a quality control line are pre-coated on the coating film. The invention introduces the magnetic immuno-chromatographic technology into the quantitative detection of tumor associated antigen 15-3, and has the advantages that the detection sensitivity is greatly improved, the accurate quantitative results can be given, the operation is simple and convenient and the diagnosis is rapid.

Description

technical field [0001] The invention belongs to the field of medical testing, in particular to a magnetic immunochromatographic test strip for quantitatively detecting tumor-associated antigen 15-3 in blood and a preparation method thereof. Background technique [0002] In 1984, Hilkens et al. made a mouse monoclonal antibody (115-DB) from the glycoprotein MAM-6 on the human milk fat globule membrane. In 1984, Kufu et al. made a monoclonal antibody (DF-3) from the liver metastatic breast cancer cell membrane. CA15-3 is a breast cancer-associated antigen, a glycoprotein with a molecular weight of more than 400kD. Patients with breast cancer often have elevated CA15-3, but the sensitivity is low in the early stage of breast cancer, and the positive rate of metastatic breast cancer can reach 80%. CA15-3 can be used as an auxiliary diagnostic indicator for primary breast cancer, and can also be used as an indicator for follow-up after surgery to monitor tumor recurrence and met...

AI Technical Summary

Problems solved by technology

[0003] The current diagnostic techniques for CA15-3 in blood mainly include: radioimmunoassay (RIA), enzyme-linked immunoassay (ELISA), chemiluminescence immunoassay (CLIA), time-resolved fluorescence immunoassay, colloidal gold immunochromatography and other methods, However, these methods have their own characteristics and shortcomings: radioimmunoassay is a commonly used method in clinical practice. Its advantages are relatively accurate results and a wide linear range. The disadvantages are cumbersome and time-consuming operations, and radioactive markers will cause harm to the operator. And it will cause environmental pollution, which has been gradually replaced by other methods

ELISA is similar to chemiluminescence and time-resolved fluorescence method in principle, but there is a difference in sensitivity due to the difference in the final detection system. At present, automation, large-scale, and quantitative detection have been realized, but there are large differences in results between methods, and the linear range is relatively small. At the same time, automated testing is currently monopolized by large foreign manufacturers, and 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 appeared to detect CA15-3, which is fast, convenient, and single-serve operation, but the disadvantage is that it can only achieve semi-quantitative, can only indicate a general range, cannot achieve accurate quantitative, and abnormal samples need to be used Other methods of rechecking and testing increase the cost of medical treatment for the testees, and it is difficult to promote them in the market, so it is difficult to be widely used

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