The Innovative Rapid COVID-19 Antigen Test Kit

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The researcher hopes that this innovative rapid COVID-19 antigen test kit will allow patients to receive diagnoses more quickly and easily. As a result, the government sector would be able to issue effective and timely measures to control and prevent the spread of the COVID-19 infection, and it will positively impact society and the economy as a whole. Please contact the Biodesign Innovation Center, Department of Parasitology, Faculty of Medicine Siriraj Hospital, Mahidol University, for more information.

Regarding the Royal Thai Gazette’s announcement publicized by the Ministry of Public Health, designating the COVID-19 Antigen Test Self-Test Kits, effective from 12 July 2021 onward, in which the medical institution can proceed immediately if ready. The FDA has released a list of 24 companies authorized to manufacture and import rapid COVID-19 antigen test kits in Thailand.

Assoc. Prof. Dr. Anchalee Tungtrongchitr, Assoc. Prof. Dr. Nitat Sookrung and the researcher team of the Biodesign Innovation Center, Department of Parasitology, Faculty of Medicine Siriraj Hospital, Mahidol University have accomplished developing an innovative rapid COVID-19 antigen test kit at an affordable price, simple instruction, and rapid test. The medical equipment factory, AFFINOME CO., Ltd., was the technology provider for manufacturing and distribution. Concurrently, the FDA approved this rapid COVID-19 antigen test kit, making it the only antigen test kit made by Thais and manufactured in Thailand from their list of 24 approved companies.

According to Assoc. Prof. Dr. Anchalee Tungtrongchitr, Chair of the Department of Parasitology, Faculty of Medicine Siriraj Hospital, Mahidol University, the laboratory-based Real-Time Reverse Transcription-Polymerase Chain Reaction Test (RT-PCR), was insufficient to deal with the rising COVID-19 contagion in Thailand. The RT-PCR diagnosis was time-consuming, expensive, and required a large number of medical personnel, limiting the number of suspected COVID-19 cases receiving the diagnosis on a daily basis.

She further said that the researchers of the Faculty of Medicine, Mahidol University, had studied and developed the innovative rapid COVID-19 antigen test kit that was able to detect the early stage of viral infection so that the patients could receive the treatment quickly. This study has been carried out since June 2020 under the gauge of the FDA. The sampling came from the
COVID-19 patients of Siriraj Hospital and the Faculty of Medicine Ramathibodi Hospital, Mahidol University. Eventually, they accomplished developing it at the beginning of 2021.

The research project's leader, Assoc. Prof. Dr. Nitat Sookrung, Head of the Biodesign Innovation Center, Department of Parasitology, Faculty of Medicine Siriraj Hospital, stated that the immunochromatographic assay was an easy-to-use and affordable feature of this “innovative rapid COVID-19 antigen test kit”. The immunochromatographic assay can detect the virus's specific protein using nasopharyngeal samples from patients. This antigen test kit provided precise and accurate results in 15 minutes without the need for lab equipment. Furthermore, the solution in the test kits can kill the virus in less than a minute, preventing COVID-19 from spreading during field tests.

“After the FDA approved this innovative rapid COVID-19 antigen test kit, the manufacturer informed Assoc. Prof. Dr. Nitat and his team that the production capacity would be 100,000 kits in July 2021 and another 200,000 kits in August 2021. The first manufacturing batch would target healthcare professionals so that community hospitals and rural areas could access proactive case findings, leading to viral infection control. While the antigen test kit for regular citizens was being improved for greater accessibility. By August 2021, it was expected to be manufactured and distributed on the market. The price should be reasonable, ranging between 250 and 300 THB per kit.”

Assoc. Prof. Dr. Nitat had previously told the press that they were currently working on an instructional video demonstrating how to use the antigen test kit safely and effectively for ordinary citizens. For example, when collecting the anterior nasal swab, insert a swab about 2 centimeters deep into the nostril, then roll the swab to collect as much of the specimen as possible. Aside from these instructions, it also covered how to insert a swab into the solution correctly, how to read the lateral flow, and how to collect and destroy antigen test kits so that they do not become infectious waste in the future.

He also stated that the anterior nasal swab antigen test kit was as effective as the nasopharyngeal swab. Furthermore, the antigen test kit was a diagnostic method of screening high-risk asymptomatic patients because it detected patients with high viral load in the early stages of infection. The innovative COVID-19 antigen test kit enabled patients to receive treatment on time and be isolated from others to avoid mass infection. Nonetheless, the outcome was initially negative. In that case, the suspects of infection must repeat the diagnosis after 4-5 days, along with strict quarantine and symptom observation. If the results are negative again, but the patients have obvious symptoms, they should see a doctor immediately for further diagnosis.

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Department of Parasitology, Faculty of Medicine Siriraj Hospital, Mahidol University
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