The first hospital affiliated to Zhengda in China's largest hospital and the eight pre-operative screenings in Henan Province must use enzyme-free rather than chemiluminescence because...

Release date: 2017-07-20

Today's Xiaobian and everyone discuss: Henan Provincial Health and Family Planning Commission on standardizing the new rural cooperative medicine reimbursement of essential drugs and basic medical treatment project catalogue to the provincial and municipal governments directly under the county (city) Health and Family Planning Commission (health bureau), provincial new The Agricultural Cooperative Medical Office has notified the relevant issues, which clearly states that the screening of infectious diseases is regulated:

First, strict indications for screening are strictly limited. Patients undergoing surgery and invasive procedures (all medical operations involving surgical procedures, endoscopy, and routine medical procedures for gynaecology, obstetrics, dentistry, etc.), blood transfusions, or transfusion of blood products should be screened prior to operation. Investigate infectious diseases such as hepatitis B, hepatitis C, syphilis and AIDS;

The second is to standardize the screening method. When the designated medical institutions at all levels conduct screening for infectious diseases in hospitalized patients, they should first use enzyme-linked immunosorbent assay (ELISA), including hepatitis B (250403097), hepatitis C antibody assay (250403014), and Treponema pallidum-specific antibody assays ( 2504030531) and human immunodeficiency virus antibody assay (2504030190), the above-mentioned enzyme-linked immunosorbent assay positive, can use high-end test methods such as electrochemiluminescence.

Now that the chemiluminescence method is truly quantitative, and enzyme-linked immunoassay is only semi-quantitative, its sensitivity, accuracy, simple and fast analysis method, short detection time and wide diagnostic range have become the most mainstream detection of hepatitis in place of enzyme-linked immunoassay. The method of the project.

So why is the Henan Provincial Health and Family Planning Commission also issuing this letter? Support enzyme free of primary screening?

First of all: the large-scale use of chemiluminescence methods for hepatitis screening in hospitals is because of the high cost of chemiluminescence reagents, which can give hospitals a large income. We take the five charges of Liaoning hepatitis B as an example, and the enzyme-linked immunosorbent method is 25 yuan per person, while chemistry The illuminating method is close to 10 times, 200 yuan per person, and the top three hospitals have a 10% increase, but this will bring a great burden to ordinary patients, so the chemiluminescence method is directly used as a routine preliminary screening test. The actual significance of human hepatitis B positive and negative is open to question;

Secondly, another clinical significance of chemiluminescence detection of hepatitis is to see if there is enough antibody in the body of the person who has injected the hepatitis vaccine. Specifically, we take the hepatitis B vaccine as an example. Generally speaking, the hepatitis B vaccine is completely inoculated. After 3 months, 97% of the vaccinates can detect surface antibodies, and in the second year, the antibody titer will not be significantly weakened, and will remain at this high level, but to the third year of hepatitis B protection. The antibody maintenance rate will drop to about 74% (and the antibody titer will also decrease), which means that the antibody titer has begun to decline after 3 years of hepatitis B vaccination (but some people can maintain it for about 10 years after vaccination). Time), so hepatitis B vaccine recipients need to regularly check the hepatitis B antibody titer to determine whether it is necessary to replant in time, so the enzyme can completely meet the hepatitis B screening, and chemiluminescence determination of hepatitis is more suitable to judge the hepatitis vaccine recipients. The status of the antibody, for vaccination or cultivating time.

In summary, chemiluminescence detection has an all-round advantage over enzyme-linked detection methods, and is also an embodiment of advanced technologies and levels of medical testing, but specific methods needed to achieve actual hospital testing need to be implemented depending on the situation. Therefore, Xiaobian personally agrees with the Henan Health and Family Planning Commission in the aspect of screening for hepatitis and subsequent confirmation of the use of chemiluminescence methods.

Regarding the documents issued by the Henan Provincial Health and Family Planning Commission, the designated medical institutions at all levels should use the enzyme-linked immunosorbent assay (ELISA) to confirm the positive rate before using the high-end test method such as electrochemiluminescence. How do you think?

Source: In vitro diagnostic network (micro signal ivdivdChina)

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