Permission for Mill antibody test

Antibody tests are being performed in some countries around the world to see if patients who have recovered from coronavirus have developed immunity to the virus. However, neither the World Health Organization nor any country has so far approved this test without research and experimental use.

As part of the study, antibody tests were used to determine the extent of the infection in countries with high rates of infection, including China, the United States, and the United Kingdom. Neighboring India has also started the process of introducing antibody tests. Now Bangladesh has also started this test. This antibody test is especially important for those who are being given plasma therapy experimentally.

On June 24, the Department of Drug Administration approved antibody tests for research and experimental use. At the same time, the department has given permission to import this test kit. In this case, the United States Food and Drug Administration (FDA) has been told to follow the approved standards. The minimum sensitivity of the FDA approved kit is 93.6 percent and the specification is 95.6 percent. It is learned that three and a half thousand kits have reached Dhaka by Saturday.

At the meeting of the technical committee of the Department of Drug Administration on June 21, the minimum sensitivity and specificity of antibody test kits was fixed at 90 percent and 95 percent in the case of Bangladesh. In addition to antibodies, antigen tests are also allowed.

Deputy Director of the Department of Drug Administration. "As per the recommendation of our technical committee, antibody tests have been allowed in research and experimental work in the country," Salauddin told Kaler Kantha.

However, the national guidelines for coronary heart disease have already mentioned antibody testing.

Many experts in the country have expressed their views on antibody tests in Bangladesh and still do so occasionally. The public health center itself has invented an antibody test kit. After its experimentation, curiosity arose among the common people. The government's Department of Drug Administration has not approved the kit for the time being due to insufficient standards.

On the other hand, not being able to test everyone interested in the ongoing RT-PCR system, the government has started thinking of adopting another simple and acceptable method. In this case, the issue of antibody and antigen testing has been discussed. In addition, the country is already discussing the use of different types of RT-PCR machines or gene experts used to diagnose tuberculosis.

Experts are emphasizing on antibody test to see the level of corona antibody in the human body after 100 days of infection. Although there are differences among experts. Some say that it is important to make antibody tests available to everyone in the country right now. Again, some say, it would not be right to make this test open to everyone. Doing so will only increase the danger.

Government pathology, diagnostics and research institute (IEDCR) adviser. Mushtaq Hossain told Kaler Kantha, “Antibody tests are not open to everyone anywhere in the world. It is only being used for research purposes. In some cases in our country it has started to be used in experimental work. In addition, the government has made great strides in introducing antibody tests to people of different professions and clusters by expanding its scope. The sooner this can be done, the easier it will be to monitor the spread of the disease. The cost of foreign kits is much higher, he says. If the quality of public health kits developed in the country can be improved, it will be possible to get them more easily and at minimum cost.

Secretary General of the Bangladesh Medicine Society and the head of the Department of Medicine, Dhaka Medical College Hospital. Ahmedul Kabir told Kaler Kanth, 'At Dhaka Medical, we are testing antibodies before those who are being given plasma therapy experimentally. Apart from Dhaka Medical, it is also being used in other institutions which are offering plasma therapy. However, there is a risk that the danger will increase if it is exposed outside. It has not been exposed anywhere.

The quality of the kit is known, the sensitivity of the antibody kit used in Switzerland is 100 percent and the specification is 99.6 percent. The sensitivity of the UK kit is 100 percent and the specification is 96.6 percent. The government's Department of Drug Administration said in a letter dated June 25 that the sensitivity of the kit invented by the public health center in Bangladesh was below 60 per cent. At the same time, the letter has urged to improve the quality.

Some have secretly brought some antibody kits into the country without government approval, which is used for plasma therapy, multiple sources said.

Bangladesh Medical Equipment Importers Society Secretary General. Kamruzzaman told Kaler Kantha, “The government has approved the import of antibody kits even though it is late. According to him, we have started importing. Seven and a half thousand kits arrived from Italy till yesterday. In this case, the FDA approved standards are being followed.