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Magnetic immuno-chromatographic test paper strip for quantitatively detecting tumor associated antigen 125 in blood and preparation method thereof

A technology of magnetic immunochromatography and tumor-associated antigens, which is applied in the field of medical testing, can solve problems such as narrow linear range, operator hazards, and long time consumption, and achieve the effect of simplifying the preparation process and easy operation

Inactive Publication Date: 2010-06-30
CHEMCLIN DIAGNOSTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it should be pointed out that the sensitivity of diagnosing recurrence with elevated serum CA125 levels is lower than the specificity, that is, elevated serum CA125 levels indicate recurrence to a large extent, but normal CA125 neither indicates the presence of tumors nor the absence of tumors progress
[0003] The current diagnostic techniques for CA125 in blood mainly include: radioimmunoassay (RIA), enzyme-linked immunoassay (ELISA), chemiluminescence immunoassay (CLIA), time-resolved fluorescence immunoassay, colloidal gold immunochromatography and other methods, but these Each method has its own characteristics and shortcomings: radioimmunoassay is a commonly used method in clinical practice. Its advantages are relatively accurate results and a wide linear range. Environmental pollution 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 CA125, which is fast, convenient, and single-serve operation, but the disadvantage is that it can only achieve semi-quantitative, can only indicate a rough range, and cannot achieve accurate quantification, and abnormal samples need to use other methods Recheck testing increases the cost of medical treatment for the testees, and it is difficult to promote in the market, so it is difficult to be widely used

Method used

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  • Magnetic immuno-chromatographic test paper strip for quantitatively detecting tumor associated antigen 125 in blood and preparation method thereof
  • Magnetic immuno-chromatographic test paper strip for quantitatively detecting tumor associated antigen 125 in blood and preparation method thereof

Examples

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Embodiment 1

[0032] Preparation method of magnetic immunochromatography test strip and test paper box for quantitative detection of CA125 in blood

[0033] The preparation method of test strip and test paper box of the present embodiment comprises the following steps:

[0034] A. Antibody preparation: commercialized CA125 paired antibody was selected, dialyzed against 20mM, pH7.2 (pH7.0-7.6 are applicable) PBS at 4°C overnight for future use.

[0035] B. Preparation of coating film:

[0036] Preparation of coating buffer: 0.02M phosphate buffer (PB) with pH 7.2 was used as coating buffer, sterilized by 0.22 μm microporous membrane filter and stored at 4°C for later use, valid for two weeks.

[0037] Preparation of blocking solution: 0.02M phosphate buffered saline (PBS) containing 0.5% BSA, pH 7.2 (pH 7.0-7.6 is applicable), 0.22μm microporous membrane filter sterilization, and store at 4°C for later use , valid for one week.

[0038] Preparation of coating film: Dilute CA125 antibody t...

Embodiment 2

[0067] Except for the preparation step of magnetic particles coupled with anti-fluorescein antibody: anti-fluorescein antibody makes the ratio of anti-fluorescein antibody to magnetic particles 1:2, other steps are the same as in Example 1,

Embodiment 3

[0069] Except for the step of preparing magnetic particles coupled with anti-fluorescein antibody: anti-fluorescein antibody makes the ratio of anti-fluorescein antibody to magnetic particles 1:10, other steps are the same as in Example 1.

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Abstract

The invention relates to a magnetic immuno-chromatographic test paper strip for quantitatively detecting tumor associated antigen 125 in blood and a preparation method thereof. A coating film, a magnet particle pad combined with tumor associated antigen 125 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 125 antibody detection line and a quality control line are pre-coated on the coating film. The invention introduces the magnetic immuno-chromatographic technology and the fluorescein isothiocyanate system into the quantitative detection of tumor associated antigen 125, 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 125 in blood and a preparation method thereof. Background technique [0002] Tumor-associated antigen 125 (CA125) has a molecular weight of 220,000 to 1,000,000, and the sugar content only accounts for 24% of the total protein. CA125 is prepared from mouse anti-human papillary cystic ovarian epithelial cell line OC125. An elevated serum CA125 level is a reliable indicator of tumor presence and recurrence. CA125 can be significantly increased in 80-90% of ovarian epithelial cancers, and the CA125 content can also be significantly increased in patients with endometrial cancer, clear cell carcinoma, fallopian tube cancer and undifferentiated ovarian cancer; the positive rate of mucinous ovarian cancer patients is Low, CA125 is particularly valuable in the differentiation of benign and m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/574G01N33/533G01N33/532G01N33/552G01N33/558
Inventor 唐宝军应希堂李强胡国茂郑金来于尚永
Owner CHEMCLIN DIAGNOSTICS CO LTD
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