No signs of HIV in immunity booster
Samples of an immunity-boosting blood product that were suspected of being contaminated by HIV have been found to be free of the virus through nucleic acid tests, China’s top drug watchdog announced on Thursday.
The product — immunoglobulin — is extracted from human blood plasma for intravenous injection into a patient to boost the person’s immunity.
Earlier, on Tuesday, the National Health Commission told the National Medical Products Administration that HIV antibodies had been found in a batch of human immunoglobulin produced by Shanghai-based China Meheco Xinxing Pharma Co. The presence of the antibody suggests the presence of HIV.
Normally, the body’s immune system makes enough antibodies to fight off organisms that cause infections. But in cases of immune deficiency, the body can’t make enough of them, putting such patients at greater risk of infection. Intravenous injection of immunoglobulin treatment provides antibodies that a patient’s body is not making on its own.
A batch of human immunoglobulin produced by Meheco was found positive for the HIV antibody based on checks in Jiangxi province. It was not clear how the immunoglobulin became tainted.
The administration sent teams to Shanghai and Jiangxi and ordered its Shanghai bureau to launch site inspections and conduct tests on the immunoglobulin supply.
The nucleic acid (NAT) tests for HIV, HBV and HCV all came back negative, the administration said in a statement on Thursday. The NAT results for HIV patients in Jiangxi were also negative, it said.
The products in question have been sealed and medical institutions nationwide have been ordered not to use them.
The company has been ordered to suspend production, and an emergency recall was issued pending the outcome of the investigation. All related products of the company have been seized and samples have been sent for inspection, according to a statement by the Shanghai Food and Drug Administration on Wednesday.
Wang Yuedan, a professor of immunology at Peking University, told Science and Technology Daily that the negative results are good news as they suggest a low risk of spreading HIV.
“Although the nucleic acid (NAT) test is negative, it doesn’t conflict with the antibody-positive test result, as the two tests are not the same,” he was quoted by the paper as saying on Friday.
Nucleic acid is the genetic material of the HIV, so its being negative shows the product may not be contaminated genetically, Wang said.
The National Health Commission, citing health experts, said people who have used the immunoglobulin have a “very low” risk of contracting AIDS.
The commission said it has formulated a follow-up monitoring program for patients who had received injections and is providing guidance to local authorities regarding followup observations of patients.
People’s Daily commented on Wednesday that a thorough investigation should be conducted to respond to public concerns and the problems should be handled in accordance with the law.
Although the nucleic acid (NAT) test is negative, it doesn’t conflict with the antibody-positive test result, as the two tests are not the same.” Wang Yuedan, a professor of immunology at Peking University