invention working group Innovative antigen test kit for novel coronavirus disease 2019
Siriraj develops a rapid test kit for novel coronavirus-specific antigens based on immunochromatography provide accurate test results No laboratory tools required The test takes only 15 minutes and can be detected in the early stages of infection. The only one produced in Thailand that has passed the performance evaluation. and licensed to produce and distribute from the Food and Drug Administration (FDA).
Assoc. Prof. Dr. Anchalee Tangtrongchit, MD, Head of Department of Parasitology Faculty of Medicine Siriraj Hospital said that Thailand has begun to be infected with the Covid-19 virus. Widely since last April This makes the traditional diagnosis using RT-PCR a bottleneck, even though we have a lot of laboratories. But it takes time to do. Therefore, there will be people who have been waiting for the results for quite a long time. And there are quite a lot of people who haven’t checked.
From the aforementioned problems led to the development of a rapid development of an innovative antigen test kit for novel coronavirus 2019 by the Faculty of Medicine Siriraj Hospital. Mahidol University It can be detected in the early stages of infection. Make the patient receive treatment faster. Importantly, at this time, it will be used to separate the patient from the family. or separated from the community to prevent the spread of the epidemic Where the patient does not need to wait in line for RT-PCR examination and return home, the results are still unknown, which at that time may spread the infection to others around him.
Assoc. Prof. Dr. Nithat Sukrung as the research project leader Department of Parasitology Siriraj Hospital Faculty of Medicine said, “The development of this test kit started in June last year with the design, planning and development of a virus detection reagent. by a research team from the Biomedical Innovation Design Center, Department of Parasitology, Faculty of Medicine Siriraj Hospital. and the Faculty of Tropical Medicine, Mahidol University.”
Siriraj Hospital Faculty of Medicine Siriraj Hospital Rapid Test Antigen Specific Antigen 2019 Mahidol University It is a quick and simple test kit that detects virus-specific proteins. in the nasopharyngeal sample of the patient in the development of the test kit The researchers selected non-variable proteins on the surface of the virus. that is, it chooses to use proteins inside the virus. So there is little chance of variation.
This test kit is used by healthcare professionals. This assay has 96% diagnostic sensitivity and 100% diagnostic specificity without the use of laboratory equipment. It takes only 15 minutes to test and pass performance evaluation. and has been licensed to produce and distribute from the Food and Drug Administration (FDA). The medical device factory Affinome Company Limited is a technology transfer company for production and distribution.
The potential for rapid production of coronavirus-specific 2019 antigen test kits from the factory. The medical personnel model is now using 100,000 sets per month. But as the demand for rapid test kits is currently increasing, in August the factory will increase its production capacity to 200,000 sets per month.
For the home use test kit (Home Use) is in the process of submitting documents and adjust the product form to meet FDA standards when approved. It is expected to be able to produce in early August. The appearance and usage pattern is similar to that of a pregnancy test kit. The selling price is expected to be 250-300 baht. The box will tell you how to use it in detail. and prevent the spread of infection with virus disinfectant within 1 minute
Both the medical personnel use and the home-use test kit are the same product. But home-use will adjust the method of collecting samples to make it easier for the people by using a swab to poke deep into the nasal cavity. to the back of the nasal cavity Nasopharyngeal swab is adjusted to use a wooden swab inserted into the anterior nasal cavity at a depth of only 2 centimeters, without having to go deep into the inner wall. The accuracy of the examination will remain the same as the test kits used by healthcare professionals.
“The primary way to protect yourself from COVID is Leave the house only when necessary. Avoid crowded places. Wear a mask at all times when outside the house. Keep a distance of at least 1-2 meters from other people. Avoid touching the eyes, mouth and nose with your hands. Eat cooked food and should be in separate decks. Do not use common items to wash hands frequently. with soap or alcohol gel The cooperation from all of us is important to help prevent and reduce the spread of COVID-19 around us.” Assoc. Prof. Dr. Nithat Sukrung finally said.