Notification of Application of Public Medical Insurance to the New Gene Detection Kit “SARS-CoV-2 RT-qPCR Detection kit” for Coronavirus that Greatly shortens PCR Test Time
We reported on April 3, how Fujifilm was developing a fast test for Coronovirus. Here are the latest updates form Fujifilm.
Notification of application of public medical insurance to the new gene detection kit “SARS-CoV-2 RT-qPCR Detection kit” for coronavirus that greatly shortens PCR test time (Fujifilm Wako Pure Chemical)
translated from Japanese
May 1, 2020 FUJIFILM Wako Pure Chemical Industries, Ltd.
FUJIFILM Wako Pure Chemical Industries, Ltd. (Head Office: Chuo-ku, Osaka, President: Kazuo Shiraki) has announced that the research drug “SARS-CoV-2 RT-qPCR Detection kit” released on April 15 is a health-related Ministry of Health, Labor and Welfare. In the “Regarding 2019-nCoV gene testing method for which evaluation results using clinical specimens were obtained” by the Department of Tuberculosis and Infectious Diseases Division and the National Institute of Infectious Diseases (May 1, 2020 edition), the positive concordance rate, The results were published with both negative and negative concordance rates of 100% and were covered by public medical insurance. * 1 So let me know.
PCR tests for the presence of new coronavirus infection include sample pretreatment, RNA extraction, and reverse transcription reaction that converts RNA into DNA. * 2 , Real-time PCR for real-time monitoring of target DNA amplification * 3 It is necessary to go through each step of, and it takes a long time to judge the result.
By utilizing the detection know-how and technology that we have cultivated so far, we focused on the reverse transcription reaction and real-time PCR to improve efficiency at each stage and reduce the reaction time by about 90 minutes in total. ※Four Successfully developed a test kit for the PCR method. In addition to the reaction reagents, the National Institute of Infection’s published primers ※Five And probe * 6 Since April 15th, we have been selling it in Japan as a detection kit that includes all the reagents necessary for the test as a set.
In order to meet the market needs accompanying the increase in the number of inspections, we have begun to strengthen the production increase system. In July, we increased the production volume to three times the current supply volume (about 50,000 samples / month). I plan to raise it to. We are considering further advancement in response to the fact that we have been covered by public medical insurance this time.
Based on the idea of ”creating the source of happiness for people, which does not have the power of the next science,” which is the basis of our business activities, we supply a new coronavirus infectious disease (COVID-19) detection kit. It contributes to speeding up the new coronavirus test.
* 1 Office of Health, Labor and Welfare Ministry of Health, Labor and Welfare, Office of Medical Affairs dated March 18, 2013 (Sending of Interpretation Material (Part 22)
* 2 Method of converting RNA into DNA (reverse transcription) using reverse transcriptase) Since no method for amplifying RNA itself has been established, detection will proceed.To do so, reverse transcription of RNA to DNA is required.
* 3 A technique that quantitatively monitors the increase in the target DNA to be amplified in real time using a fluorescent dye. * 4 In the stages of reverse transcription reaction to real-time PCR using this reagent, the reaction time, which was conventionally over 2 hours, was shortened by about 90 minutes. * 5 Short-chain (about 20 bases) DNA that becomes the origin of replication of the target DNA during PCR reaction * 6 DNA that specifically binds to the unique base sequence in the target DNA.
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