Kit for detecting HER2 gene amplification

A detection kit and gene amplification technology, which is applied in the determination/testing of microorganisms, fluorescence/phosphorescence, biochemical equipment and methods, etc., can solve the problems of high price, high economic loss, and delay of other programs, so as to avoid fake Positive and ambient contamination, high specificity, inexpensive effect

Active Publication Date: 2011-09-28
DAAN GENE CO LTD
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Problems solved by technology

The current immunohistochemical (IHC) detection method widely carried out in hospitals cannot completely and correctly judge the status of HER2 in patients
Because even about 10% of IHC (3+) patients do not have HER2 gene amplification, and these patients cannot benefit from the treatment of Herceptin, which not only causes high economic losses, but also delays the application of other programs Opportunity
In IHC (0) and (1+), there are nearly 10% false negatives, and for these patients, the opportunity to obtain an effective treatment plan will be lost.
In the 2007 first edition of the "Breast Cancer Clinical Practice Guidelines (China Edition)", the HER2 detection principles pointed out that IHC method or FISH technology can be used for the first assessment of tumor HER2 gene amplification status, and the IHC detection results are borderline samples (such as IHC++) should be re-tested by other methods that have been verified (such as FISH), but only a few hospitals in China are capable of carrying out this test, and FISH testing reagents are monopolized by foreign companies, the price is very expensive, and most patients cannot Bear such a high cost of testing, and lose the opportunity to obtain accurate and standardized test results

Method used

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  • Kit for detecting HER2 gene amplification
  • Kit for detecting HER2 gene amplification
  • Kit for detecting HER2 gene amplification

Examples

Experimental program
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Embodiment 1

[0023] Embodiment 1 HER2 gene amplification detection kit and its use

[0024] 1. Prepare a kit including the following components: 1 tube of PCR reaction solution (820 μl / tube), 1 tube of Taq enzyme system (80 μl / tube), 1 tube of positive quality control (30 μl / tube), 1 tube of negative quality control ( 30μl / tube) 1 tube.

[0025] 2. Collection, preservation and transportation of specimens:

[0026] 2.1 Applicable specimen types: paraffin-embedded tissue, frozen tissue.

[0027] 2.2 Specimen collection: Immediately after surgery, tumor tissues were frozen and stored at -20°C or processed as paraffin-embedded tissues according to routine procedures.

[0028] 2.3 Preservation and transportation of specimens: Paraffin-embedded tissues can be stored at room temperature for a long time; fresh tissues should be stored at -20°C for testing, and the storage period is 6 months. Dry ice is used for long-distance transport of specimens.

[0029] 3. Nucleic acid extraction:

[0030...

Embodiment 2

[0038] Example 2 Application of HER2 Gene Amplification Detection Kit to Detect Clinical Samples

[0039] 4 cases were selected as negative for HER gene amplification by FISH method, and 3 cases were detected as positive for HER2 gene amplification by FISH method. The nucleic acid extraction, PCR amplification and result analysis of the samples were carried out with reference to Example 1, and the negative and positive results were carried out simultaneously. Testing of quality control products.

[0040] Interpretation of the test results: the amplification curve of the negative quality control product is an S-shaped curve with good overlap, and 0 figure 2 ). The amplification curve of the positive quality control product is an S-shaped curve, and the ΔCt value is greater than 1, which is within the quality control range of the kit, indicating that the detection system can effectively detect the amplification of the HER2 gene (see attached image 3 ). Both negative and posit...

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Abstract

The invention relates to a kit for detecting breast cancer HER2 gene amplification, especially to a kit for detecting HER2 gene real-time fluorescence polymerase chain reaction. By the utilization of the real time fluorescence PCR technology, the kit provided by the invention detects the amplification level of the HER2 gene in a breast cancer tissue specimen by calculating Delta Ct value, and canbe applied in a plurality of research fields such as the auxiliary diagnosis, clinic and prognosis of breast cancer.

Description

technical field [0001] The invention relates to a breast cancer HER2 gene amplification detection kit, in particular to a HER2 gene real-time fluorescent polymerase chain reaction detection kit. The kit can detect the level of HER2 gene amplification, and can be widely used in auxiliary diagnosis of breast cancer caused by HER2 gene amplification, guiding clinical medication, prognosis and other research fields. Background technique [0002] Breast cancer is the most common cancer occurring in women worldwide, with 1 million new cases and nearly 400,000 deaths from breast cancer each year. According to the 2006 cancer incidence rate and top ten malignant tumor incidence rankings in my country provided by the Cancer Prevention and Control Office of the Ministry of Health, breast cancer ranks first in the incidence of female malignant tumors, and the age of onset tends to be younger. Although the current treatment of breast cancer has made considerable progress, most of the t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/68G01N21/64
Inventor 李明陈华云邓艳华
Owner DAAN GENE CO LTD
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