p16 is an early found tumor suppressor gene, which can inhibit the metastasis of various tumors. The product of p16 gene encoding, p16 protein, also known as p16, mainly exists in the nucleus and cytoplasm, and plays a tumor suppressor role by causing cell cycle arrest. Ki-67 protein is related to cell proliferation and is expressed in the nucleus. Ki-67 high expression indicates that cells are in a high growth stage, and the level of its marker index is related to the grade of cervical lesions.
In normal cells, the expression of p16 and Ki-67 antagonized each other. If the two proteins are expressed in the same cell, it indicates that the cell cycle is dysfunctional and cancerous. Therefore, p16/Ki-67 double staining can be used to detect cervical precancerous lesions.
In a specific low osmotic pressure salt solution, the whole blood sample was added in a certain proportion, and after mixing, the red blood cells in the whole blood sample were fully dispersed in the solution. Because the osmotic pressure inside the red blood cells in the mixed solution is higher than that in the salt solution with low osmotic pressure, water molecules enter the red blood cells through the cell membrane. When the water molecules penetrate into the red blood cells to a certain extent, the red blood cells will expand and rupture and hemolysis. Under the condition that the concentration of low osmotic pressure salt solution is fixed and the proportion between the amount of whole blood and the amount of low osmotic pressure salt solution is fixed, the greater the osmotic brittleness of red blood cells is, the greater the percentage of hemolysis is, that is, the osmotic brittleness of red blood cells is proportional to the percentage of hemolysis.
According to this principle, two equal amounts of whole blood samples were placed in a specific concentration of low permeability salt solution and pure water, and the scattered light intensity of the two tubes of mixed liquid was detected immediately after mixing, and then the scattered light intensity of the two tubes of mixed liquid AL and BI was detected after hemolysis. The percentage of hemolysis can be obtained according to the following formula. It reflects the permeability fragility of the red blood cells in the sample
Reagent blank: When testing purified water or blank samples, the scattered light intensity should not be greater than 5000
Positive coincidence rate: Test samples with reduced hemolysis rate, positive coincidence rate should be >90%(n>10)
Negative coincidence rate: Test normal samples, negative coincidence rate should be >90%(n>10)
Repeatability: Repeated tests were conducted on samples (n>10) with two levels of normal people and those with reduced hemolysis rate
The number (CV) should not be greater than 10%
Difference between batches: three batches of kits were taken and the samples of normal people and those with reduced hemolysis rate were tested repeatedly (n>10).
The coefficient of variation (CV) of the results obtained should not be greater than 10%
