1、 Balance: Before operation, balance the reagent at room temperature for 30-60 minutes. 2、 Sampling: 1. The sample is serum: it is better to store the blood naturally for 1-2 hours, and then centrifuge with 3000 rmp for 15 minutes; 2. The sample is plasma: the blood sample collection tube containing anticoagulant must be used. After blood collection, the blood collection tube must be immediately inverted and mixed for 5-10 times. After a period of time, 3000 rmp centrifugation for 15 minutes; If it is detected within a few days, it can be placed in a refrigerator of 2-8 ℃; if it is to be stored, it can be placed in a low-temperature refrigerator of - 20 ℃; 3. After adding the sample, put it into the incubator in time. After adding the enzyme reagent, gently wipe the surface of the enzyme label plate with absorbent paper to absorb;
EB virus is an important DNA virus that infects human beings. There are many diseases related to EBV infection, especially nasopharyngeal carcinoma. With the development of modern molecular biology, the diagnosis of EBV infection has made rapid progress from principle to method. Due to the high operational requirements, expensive equipment and reagents, the application of pathogen detection is limited, so the immunoserological detection of EBV infection is the most commonly used method for NPC screening at present. The early diagnosis and clinical stage of NPC are of great significance to the curative effect of radiotherapy.
1. Sensitivity The sensitivity of a diagnostic reagent has two different meanings: first, the sensitivity represents that the reagent has the ability to detect the minimum amount of substances to be tested; Secondly, sensitivity also indicates the positive detection ability of the reagent in the population or a large number of samples, that is, the degree of false negative. Sensitivity is the primary quality standard of diagnostic reagents. If the sensitivity of the reagent does not meet the standard, then the reagent is worthless.
May 28, 2008, the State Food and Drug Administration Certification Center organized experts to our company, our company's quality system assessment. After a site inspection, document review, instant questioning strict examination session, the experts on the situation of the company's quality system that fully affirmed and highly praised and consistent assessment of the company through this assessment. I also become the first two one-time quality system assessment by in vitro diagnostic reagent manufacturers. Last April, the State Food and Drug Administration issued the "