Triple test diagnostic kit for breast cancer

A diagnostic kit, breast cancer technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of single index detection, limited product promotion and application, low sensitivity and specificity, etc., to achieve high sensitivity and reduce interference , good test repeatability effect

Active Publication Date: 2016-08-17
赛特斯(海南)生物医学有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, the existing serum detection kits can only detect a single indicator, and there are defects of low sensitivity and specificity in the detection process, which greatly limits the promotion and application of the above products

Method used

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  • Triple test diagnostic kit for breast cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1, breast cancer triple detection diagnostic kit

[0027] 1. Preparation of breast cancer triple detection kit

[0028] 1.1. The preparation method of the antibody microtiter plate is as follows:

[0029] Dilute the anti-CA125, HE4 and p-her2 monoclonal antibodies to 60 μg / ml with PBS buffer at pH 8.2, add 100 μl / well to the 96-well microtiter plate, and keep the temperature at 4°C Stand overnight, then wash with washing solution, the washing solution is phosphate buffer solution containing 0.05% Tween 20, pH 7.4, and spin dry to obtain 96 wells coated with anti-CA125, HE4 and p-her2 monoclonal antibodies ELISA plate.

[0030] 1.2. The preparation method of the biotin-antibody-coated plate is as follows:

[0031] Mix CA125, HE4 and p-her2 monoclonal antibodies with activated biotin for labeling, and dialyze to remove unbound biotin to obtain biotin CA125, HE4 and p-her2 monoclonal antibodies; use PBS buffer with pH 8.2 Dilute CA125, HE4 and p-her2 monoclo...

Embodiment 2

[0050] Embodiment 2, the accuracy test of breast cancer triple detection diagnostic kit

[0051] The CV value of the coefficient of variation of the coated 96-well ELISA plate prepared by the present invention is less than 8%, and the test kits of the same batch and different batches are tested, and the test results show the CV values ​​of the kits in the batch and between batches All are less than 8%, indicating that the breast cancer triple detection diagnostic kit of the present invention has high precision.

Embodiment 3

[0052] Embodiment 3, sensitivity test of breast cancer triple detection diagnostic kit

[0053] Using CA125, HE4 and p-her2 standards to prepare different concentrations of the test solution, as shown in Table 2:

[0054] Table 2 Standard test solutions of CA125, HE4 and p-her2 with different concentrations

[0055]

[0056] As can be seen from Table 2, the breast cancer triple detection diagnostic kit prepared in Example 1 was used to test the test solution at each concentration for determination, and the detection was performed by a microplate reader, and each concentration was determined 3 times.

[0057] The results show that the breast cancer triple detection diagnostic kit prepared in Example 1 has excellent sensitivity, the sensitivity of CA125 is <1U / ml, the sensitivity of HE4 is <3pmol / L, and the sensitivity of HCG is <1IU / mL.

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Abstract

The invention belongs to the field of biological detection and specifically relates to a triple test diagnostic kit for breast cancer of tumor serum markers CA125, HE4 and P-her2. The triple test diagnostic kit for breast cancer provided by the invention mainly comprises an abzyme elisa plate, a biotin antibody enveloped plate, bovine serum albumin, serum diluent, horse radish peroxidase, tetramethyl benzidine, sulfuric acid, negative control liquid and positive control liquid. The triple test diagnostic kit for breast cancer provided by the invention can be used for detecting the expression levels of CA125, HE4 and P-her2 in the body of the patient after operative treatment or the relapsing and metastatic tumor patient; the triple test diagnostic kit for breast cancer has important significance in clinical diagnosis of breast cancer; the triple test diagnostic kit for breast cancer provided by the invention can reduce the interference of other matters in serum, can greatly increase the accuracy and stability of detection result and is beneficial to the early diagnosis and prognosis treatment of the patient suffering from breast cancer.

Description

technical field [0001] The invention belongs to the field of biological detection, and in particular relates to a breast cancer triple diagnostic kit for tumor serum markers CA125, HE4 and P-her2. Background technique [0002] Breast cancer is a relatively common malignant tumor disease, and it is the female malignant tumor disease with the highest incidence rate, accounting for about 10%-12% of various malignant tumor diseases. According to relevant research, about 1.6 million people are diagnosed with breast cancer every year in the world, and about 500,000 people die from the disease every year. Moreover, the incidence of breast cancer is increasing at a rate of 4% per year, and the patient population is beginning to become younger, which seriously threatens the physical and mental health of women around the world. Therefore, it is extremely necessary to strengthen the research on breast cancer treatment technology. [0003] CA125, HE4 and p-her2 are highly expressed in...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/577G01N33/574
CPCG01N33/57415G01N33/57484G01N33/577
Inventor 陈立国
Owner 赛特斯(海南)生物医学有限公司
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