Quality control product suitable for quantitative detection of tumor marker Pro-GRP
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A tumor marker, quantitative detection technology, applied in the field of quality control products, can solve the problems of inability to meet the normal use of the laboratory, poor stability and uniformity, and inability to be suitable for detection, and achieve stable activity, long stability time, and high accuracy. Effect
Inactive Publication Date: 2019-02-15
郑州标源生物科技有限公司
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The tumor marker Pro-GRP, a quality control product prepared by this process, drops rapidly in the matrix fluid (due to the complex composition of the matrix fluid, some components make Pro-GRP less stable), resulting in poor stability and uniformity. P...
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Embodiment 1
[0015] Example 1 Preparation of Quality Control Products Suitable for Quantitative Detection of Tumor Marker Pro-GRP
[0016] Concrete preparation steps are:
[0017] The first step is to select the hormone-free serum suitable for the tumor marker Pro-GRP (purchased hormone-free human serum, the background value of Pro-GRP in the serum is ≤100pg / ml), and store it at 2-8°C after thawing;
[0018] In the second step, add 1-5g of ADP, 1-5ml of Proclin300, 1-5g of gentamicin sulfate, and 50-100g of trehalose to each liter of hormone-free serum in the first step, and stir well , to obtain a clear and translucent matrix solution, which should be stored at 2-8°C;
[0019] In the third step, take five equal volumes of matrix solution (500ml each), add 0.31μl, 1.43μl, 2.78μl, 3.85μl, 5.56μl of the same titer of tumor marker Pro-GRP antigen to obtain 1-80pg / mL, 80-200pg / mL, 200-800pg / mL, 800-1500pg / mL, 1500-5000pg / mL five groups of primary liquid tumor marker Pro-GRP quality control ...
Embodiment 2
[0025] Example 2 Performance test of the tumor marker Pro-GRP quality control product prepared by the present invention
[0026] The stability and uniformity of the freeze-dried tumor marker Pro-GRP quality control products with filling volumes of 1mL / bottle, 2mL / bottle, and 3mL / bottle were tested for stability and uniformity, and the specific results are as follows:
[0027]
[0028] It can be seen from the above table that the lyophilized tumor marker Pro-GRP quality control product can be stored at 2-8°C for 7 days after reconstitution after opening the bottle (decrease ≤15%), the variation within the bottle is ≤15%, and the variation between the bottles is ≤10 %, effectively improving the stability and uniformity of Pro-GRP.
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Abstract
The invention discloses a quality control product suitable for quantitative detection of a tumor marker Pro-GRP, comprising the following steps of: first, selecting a de-hormone serum suitable for thetumor marker Pro-GRP, and then storing at 2-8 DEG C after thawing; successively adding 0.1-0.5% ADP, Proclin300, gentamicin sulfate, and 1%-10% trehalose to an matrix solution and storing at 2-8 DEGC; adding a tumor marker Pro-GRP antigen into the matrix solution, and then adding lauryl sodium sulfate to obtain the quality control product of a liquid tumor marker Pro-GRP; and dispensing the product in a brown glass bottle, obtaining a finished product of the quality control product of the tumor marker Pro-GRP after performing vacuum freeze drying, and storing the finished product in a refrigerator at 2-8 DEG C. The quality control product of the tumor marker Pro-GRP prepared by the invention has good uniformity and stability, is not affected by transportation, temperature and the like, and can be applied to quantitative detections of different instrument models and different reagents. The quality control product is a lyophilized product, and has reliable quality and high accuracy. The raw materials for preparing the quality control product are widely used, the preparation method is simple, and the cost is low.
Description
technical field [0001] The invention relates to tumor markers, in particular to a quality control product suitable for the quantitative detection of the tumor marker Pro-GRP. Background technique [0002] Lung cancer is currently the most common cancer type in China with the highest incidence rate among men and the second highest incidence rate among women. The mortality rate of lung cancer ranks first among all malignant tumors. Realizing early detection, early diagnosis and early treatment of lung cancer has important medical value to improve the long-term survival of patients. [0003] Pro-GRP, the precursor of gastrin-releasing peptide (GRP), has a similar structure to bombesin in mammals and amphibians and has been used for many years in the histopathological classification of the lung. GRP functions as a neurotransmitter in the human nervous system and is also present in neuroendocrine cells of the gastrointestinal tract and respiratory tract. Due to the instability ...
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