Shanghai Hengyuan analyzes aspects of ELISA kit experiments for new employees

This morning, Mr. He Hengyuan from Shanghai analyzed and explained the new employees [ELISA kit] The aspects of the experiment need to be considered. The collection of serum samples for the detection of antigens and antibodies, tumor markers and special proteins of infectious pathogens is not available. What are the aspects of time and position, so what should be considered in terms of handling and preservation?

1. If the specimen is turbid or floc due to bacterial contamination during storage, the supernatant should be taken after centrifugation and sedimentation.

2. If the serum sample is isolated by aseptic operation, it can be stored at 2-8 °C for one week. If it is operated by bacteria, it is recommended to freeze it. Long-term storage of the sample should be below -70 °C.

3, sample collection and serum separation should pay attention to avoid bacterial contamination, a bacterial growth, the secretion of some enzymes may decompose proteins such as antigens and antibodies; second, some bacteria endogenous enzymes such as the large intestine The beta-galactosidase of Bacillus itself produces non-specific interference with assays labeled with the corresponding enzymes.

4. Serum samples stored in frozen water should be taken care of to avoid repeated freezing and thawing caused by power outages. The mechanical shear force generated by repeated freezing and thawing of the specimen will destroy the molecules such as proteins in the specimen, causing false negative results. In addition, the mixing of freeze-thaw specimens should also be noted, do not violently shake, and repeatedly invert and mix.

5, should pay attention to avoid serious hemolysis. Hemoglobin contains a heme group, which has a peroxide-like activity. Therefore, in an ELISA assay using HRP as a labeling enzyme, if the hemoglobin concentration in a serum sample is high, it is easily adsorbed during the incubation. In the solid phase, it reacts with the HRP substrate added later to develop color.

In the end of this [ELISA kit] experimental analysis discussion, my company manager also reminded me:

1. When mixing the protein solution, try to be gentle and avoid foaming.

2. Do not replace the reagents in the kit with reagents from other manufacturers.

3. Please make a standard curve at the same time of each measurement. It is best to make a double hole. Hengyuan Central Inspection Institute standard products, management management points

At 8:50 am yesterday, Mr. Wang, Manager Wu, Manager Xia and Manager He of our company discussed the management management problems of the [standards of the Central Inspection Institute] together with the technical staff. Finally, several essentials were summarized and shared here. Announced to everyone.

1, check

Strictly speaking, when the new product purchase catalogue is released, if the original batch is inconsistent with the batch number on the current purchase catalogue, it should not be used directly, at least after comparison with the new batch number.

2, storage

Due to its particularity, its storage conditions and methods are very important and have a great impact on its stability and accuracy. Therefore, when the standard substance is purchased, first read the attached label and the instructions on the storage conditions carefully, and store it in strict accordance with the specified conditions.

Shanghai Hengyuan's latest [China Standards Institute Standard] (authentic agent, quality 100% guarantee):

Ketoconazole

Vitamin C sodium

Thiamine nitrate

Dioxetazine hydrochloride

Loperamide hydrochloride

Astemizole

Clobetasol propionate

Vitamin A

Manager Shanghai Hengyuan Wu specially put forward: "Because the standard method for measuring the standard content of drugs is more commonly used in the comparison method, in the measurement process, only one control solution is prepared, which may cause the deviation of the process of preparing the control solution, which is impossible to identify. Test error. Therefore, the method of operation should be standardized, and two control solutions should be prepared at the same time to control the test error."

Finally, we conclude that, in summary, based on its key role in the quality control process of pharmaceuticals, production companies should strictly manage and standardize operations in the process of purchase, storage, use, and production of reference materials to reduce the inspection process. The deviations and errors appearing in the laboratory improve the quality and efficiency of the inspection work, and ultimately ensure the accuracy of the drug inspection work, thereby ensuring the quality of the drug. This is also one of the important tasks in the implementation of GMP by the quality management department.

Shanghai Hengyuan [standards of the Central Inspection Institute] price is absolutely reasonable, and the quality of our company's products is also 100% guarantee, if necessary, you can call Shanghai Hengyuan He manager.

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