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Time-resolved fluorescent immunochromatographic test strip for quantitatively detecting CA153 in blood and preparation method

A technology of time-resolved fluorescence and immunochromatography test strips, which is applied in the field of medical testing, can solve problems such as difficulty in large-area use, large difference in results, and inability to achieve accurate quantification, achieving the effect of convenient clinical diagnosis and easy operation

Inactive Publication Date: 2018-09-14
SHENZHEN MICRO BIOLOGICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The current diagnostic techniques for CA153 in blood mainly include: enzyme-linked immunoassay (ELISA), chemiluminescence (CLIA), colloidal gold immunochromatography and other methods, but these methods have their own characteristics and shortcomings: ELISA and chemiluminescence and time The principle of the resolution fluorescence method is similar, but there is only a difference in the sensitivity. At present, most of them have realized automation, large batches, and quantitative detection, but there are shortcomings such as large differences in results between methods and narrow linear ranges. In addition, automated detection is currently carried out by large foreign manufacturers. Monopoly, expensive equipment, and not suitable for single-serving and small-batch testing, greatly limiting their application in primary hospitals and clinics. In recent years, colloidal gold immunochromatography has emerged to detect total CA153, which is fast and convenient. Single-serving operation, but the disadvantage is that it can only achieve semi-quantitative, can only indicate a general range, can not achieve accurate quantitative, and because of the limitation of the sensitivity of colloidal gold, it cannot detect low-concentration CA153, and abnormal samples need to be checked by other methods, invisible It increases the cost of medical treatment for the test subjects, and it is difficult to promote in the market, and it is difficult to use it on a large scale

Method used

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  • Time-resolved fluorescent immunochromatographic test strip for quantitatively detecting CA153 in blood and preparation method
  • Time-resolved fluorescent immunochromatographic test strip for quantitatively detecting CA153 in blood and preparation method
  • Time-resolved fluorescent immunochromatographic test strip for quantitatively detecting CA153 in blood and preparation method

Examples

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Effect test

Embodiment 1

[0041] Example 1 Preparation method of time-resolved fluorescent immunochromatography test strip and kit for quantitative detection of CA153 in blood

[0042] The preparation method of the present embodiment comprises the following steps:

[0043] A. Preparation of NC membrane:

[0044] Coating buffer preparation: 0.05 mol / L PB buffer solution with pH 7.4 and 1% trehalose, sterilized by 0.22 μm microporous membrane filter and stored at 4°C for later use, valid for two weeks.

[0045] Coating of NC membrane: Dilute the CA153 antibody to 0.8mg / mL and the rabbit IgG to 1.0mg / mL with coating buffer, and use a quantitative spraying device to spread the two evenly at an interval of 0.6cm Spray-print on a nitrocellulose membrane with a width of 2.5cm, and then dry it at 45°C for 72 hours, add a desiccant and seal it for later use.

[0046] B. Preparation of fluorescent microsphere antibody:

[0047] Preparation of 0.05mol / L MES buffer solution: Prepare MES buffer solution with a p...

Embodiment 2

[0069] Except for the preparation step of the fluorescent microsphere antibody: the molecular ratio of the CA153 antibody to the latex microsphere is 10:1. Other steps are the same as in Example 1.

Embodiment 3

[0071] Except for the mixing step of the fluorescent microsphere antibody: using the conjugate diluent to dilute the mixture at a ratio of 1:10 to be sprayed on the glass fiber mat, other steps are the same as in Example 1.

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Abstract

The invention relates to a time-resolved fluorescent immunochromatographic test strip for quantitatively detecting CA153 in blood and a preparation method thereof. The test strip is a test card formedby successively bonding an NC film, a CA153 antibody and mouse anti-rabbit IgG marked fluorescent microsphere conjugate pad, a sample pad and an absorbent pad on a white PVC substrate staggeredly at2 mm and then using upper and lower matched plastic card holder to fix the test strip for assembling, and the NC film is pre-coated with a CA153 antibody detection line and a rabbit IgG quality control line. According to the test strip, a time-resolved fluorescence immunochromatography technology is introduced into the quantitative detection of the CA153 in the blood, the detection time is greatlysaved, the stability and sensitivity of detection are improved, the operation is simple and convenient, and the test strip can be used for on-site screening; the test strip has the advantages of lowcost and high cost performance.

Description

technical field [0001] The invention belongs to the field of medical testing, in particular to a time-resolved fluorescent immunochromatographic test strip for quantitatively detecting CA153 in blood and a preparation method thereof. Background technique [0002] CA15-3 is the most important specific marker of breast cancer. 30%-50% of breast cancer patients have significantly increased CA15-3, and the change of its content is closely related to the treatment effect. It is the best indicator for breast cancer patients to diagnose and monitor postoperative recurrence and observe the curative effect. Dynamic determination of CA15-3 is helpful for early detection of recurrence in patients with stage II and stage III breast cancer after treatment: when CA15-3 is greater than 100U / mL, it can be considered as metastatic lesions. The rise and fall of serum CA15-3 levels in patients is parallel to the changes in the condition of breast cancer, which is an important signal of recurr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/577
CPCG01N33/577
Inventor 常文伟夏琳唐盛刘小平
Owner SHENZHEN MICRO BIOLOGICAL TECH CO LTD
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