On February 6, the National Health and Wellness Committee responded quickly.
Blood products are related to people's lives and are strictly regulated. Why is AIDS antibody positive still used? How did you find it? Why was it found in Jiangxi instead of Shanghai? Can HIV antibody positive in intravenous globulin lead to AIDS? A series of questions came to mind instantly.
Because it involves a lot of medical knowledge, I will briefly explain several concepts.
Blood consists of blood cells and plasma. The volume ratio of them is about 45:55.
The main component of plasma is water, and the most abundant solute is protein, including albumin, globulin and fibrinogen.
Note that albumin and globulin are two different protein. Albumin is mainly used for nutrition and transportation, and globulin is mainly used for immunity.
The content of protein in plasma is 60-80g/L, albumin is 40-55g/L and globulin is 20-30g/L. ..
Not all immunoglobulins are antibodies, but all antibodies are immunoglobulin. The extraction of immunoglobulin is mainly to extract antibody components.
Antibodies are substances produced by antigens such as bacteria and viruses, which stimulate the secretion of human B lymphocytes and have the function of destroying pathogens.
Looking through many reports, I initially clarified the origin of this matter.
Ling Ke is a newborn, because immunoglobulin is mainly used for autoimmune diseases such as low or defective immunity, severe infection and idiopathic thrombocytopenic purpura.
No matter what kind of situation the newborn is, it is very serious and needs hospitalization, which is ridiculous in itself. Now the weak HIV antibody positive is a bolt from the blue, and you can imagine how much pressure this family has suffered. If the AIDS diagnosis experiment is confirmed again, it means that the newborn has AIDS. The World Health Organization has long listed AIDS as a chronic disease, but in China, many people still talk about it.
I am very worried about whether this newborn will be infected with AIDS. Fortunately, I saw this peace of mind. The nucleic acid test results of HIV and other viruses are negative, so the possibility of HIV infection can be ruled out.
Why does the newborn appear weak positive for AIDS antibody after injecting immunoglobulin, and then there is no weak positive after re-examination? The most likely reason is that immunoglobulin contains AIDS antibodies.
Because immunoglobulin is made from the plasma of 1000 people, the original AIDS antibody is diluted and weakly positive. After that, immunoglobulin was metabolized by the newborn, and there was no weak positive in the second interview. According to the drug traceability system, the State Administration of Pharmaceutical Products found that Shanghai emerging immunoglobulin was HIV-positive.
The requirements of blood products are so strict, why are immunoglobulin AIDS antibodies positive? Is it an isolated case or full supervision? Is there a systematic safety risk in the production system?
The Measures for the Administration of Plasma Collection Stations stipulates that the plasma volume of plasma collection stations shall not exceed 580ml at a time. According to the batch number provided by the Health and Wellness Committee, * * * has 12226 bottles, each containing 2.5g immunoglobulin.
Assuming that the plasma immunoglobulin content is 30g/L, and the maximum is 580ml per person,12226 * 2.5/(0.58 * 30) =1757 people are needed. According to the provisions of the China Pharmacopoeia, plasma can only be matched with more than 1000 people, so at least one of these 1757 people is an AIDS patient. Only AIDS patients can produce AIDS antibodies. In the window period of HIV infection, the infected person has not yet produced antibodies, and there will be no AIDS antibodies in the plasma collected at this time.
Immunoglobulin products need to go through many processes, such as separation, purification and pathogen removal. , and it has to go through many tests before it can be listed.
However, the plasma containing HIV antibody was eventually used in patients, suggesting that plasma collection stations, Shanghai Xinxing and batch issuing inspection institutions did not do HIV antibody testing.
In 20 17, the number of AIDS cases in China was 57 194, and the number of deaths was 1525 1, ranking first among infectious diseases. AIDS has become a serious public health problem.
China CDC, UNAIDS and WHO jointly assessed that by the end of 20 18, it was estimated that there were about1250,000 HIV-infected people in China. By the end of September 2008, there were 850,000 survivors and 262,000 deaths. It is estimated that there are about 80 thousand new infections every year. The infection rate of the whole population is about 9.0/ 10,000. The main route of AIDS transmission is sexual contact, which means that young people are more likely to get sick. Every year, 30% of new infections go undetected.
The HIV infection rate is close to one in a thousand, and the youth group is higher. According to the probability, there is one infected person in every thousand people. Plasma, the raw material for immunoglobulin production, needs to be used by more than 1000 people.
China Pharmacopoeia 20 15 clearly requires that plasma donors are HIV-negative. According to the Regulations on the Administration of Blood Products, blood product manufacturers should conduct a comprehensive re-examination of each plasma before putting it into production, and blood products must undergo quality inspection before leaving the factory.
The Measures for the Administration of Batch Issuance of Biological Products stipulates that biological products such as blood products shall be issued in batches, that is, a system of compulsory examination, inspection and approval shall be implemented before each batch of blood products is sold. Products that fail to pass the batch issuance shall not be listed for sale or imported.
According to the Economic Observer, Shanghai Food and Drug Inspection Institute has only approved routine testing, excluding HIV testing.
There are four chances to detect HIV antibody positive in plasma collection stations, Shanghai Xinxing Prenatal and Finished Products, and Shanghai Food and Drug Inspection Institute. However, it was not detected in the end. This shows that the security loopholes are very large and need to be strictly investigated.
The State Administration of Medical Supplies issued a document suggesting the risks of using immunoglobulin, and the drug batch issuance inspection agency said that AIDS was not a compulsory item. What do plasma station and Shanghai Xinxing Association say? Who will bear the responsibility and how to fill the subsequent gaps? It is expected that the supervision and inspection department will launch the ultimate revenge, and the manufacturer can face up to the problem instead of leaving an indifferent and ignorant response: a full refund for HIV infection with this product.
Targeted anticancer drugs enter medical insurance, and serious adverse reactions caused by vaccination are compensated by funds. These are all advances in the medical industry. Immunoglobulin is expensive, but it also omits such an important HIV antibody test. Changchun Changsheng is only the vaccine titer is unqualified, and the safety is no problem. If many people use this product to infect AIDS, Shanghai Xinxing will successfully surpass Changchun Changsheng.
People's worries are justified. Didn't even do the basic HIV antibody test. Can you expect other more demanding production links to be completely fine? This is called looking at a leopard in a tube, and seeing it in detail.
More than 20 years ago, we did not pay attention to the spread of AIDS caused by selling blood. More than 20 years later, the problem of AIDS testing remains the same.
But times have changed, and the victims in those days could not shout for help. Whoever fools the people in the Internet age will surely become the next Changchun Changsheng.
During the avalanche, not a single snowflake was innocent. After all, you have to pay back what you mixed up.