科技部新聞稿
科研成果跨國合作協助抗疫
12分鐘快速檢測COVID-19 準確率達9成
日期：2020年4月8日
發稿單位：產學及園區業務司
聯絡人：林月美助理研究員
電話：(02)2737-7240
Email：ymlin@nstc.gov.tw
因應緊急疫情，台灣丹麥國際技術合作，即時檢測產品快速完成
正當COVID-19疫情爆發之際，各國亟需即時檢測產品，柏勝生技成功開發COVID-19檢測設備，能在12分鐘內快速完成檢測。今(2020)年3月初已完成COVID-19血清檢測碟片開發，並在中壢天晟醫院協助下，持續優化檢測系統。上週於丹麥第二大醫院Hvidovre hospital執行初步的臨床驗證，靈敏度高達90%，此結果令當地醫生十分振奮。下周在義大利醫院將完成更大量的臨床驗證，預計在5月取得歐盟認證。
柏勝生技(BluSense Diagnostics)成立於2014年，是科技部萌芽計畫衍生新創公司，並已獲台安生技及廣明光電投資。該公司生化研發基地座落於丹麥哥本哈根，而軟硬體研發中心與設備生產則位於台灣桃園。柏勝生技擁有國際團隊，並結合台灣IT產業優勢，以藍光光碟機為基礎，設計開發可攜式醫療檢測平台BluBox，並搭配微流道生物檢測碟片ViroTrack，攜帶與操作均十分便利，適合於機場、港口等第一線防疫場所使用。期待能協助一些檢測量能比較不足的國家或地區，做為快速篩檢工具。
一滴血12分鐘得到結果，減低醫檢實驗室沉重負擔！
柏勝生技克服現有檢測系統困境，發展出兼具高準確性、攜帶方便與操作簡易之產品。僅需受測者一滴血液檢體(30 ul)，毋須進行離心等前處理，12分鐘即可取得定量且高靈敏度(sensitivity)與專一性(specificity)之檢測結果。
IgM是感染初期出現的抗體，可用於疑似病例之早期篩檢；IgG則於感染中後期出現，可了解患者處於恢復期或是否曾被感染。博勝在臨床上同時檢測IgM/IgG，可動態瞭解患者處於何種感染階段。柏勝生技COVID-19血清測試可用於：
(1)社區回溯與檢測疑似無症狀患者
目前針對COVID-19以PCR為主要檢測方式。PCR需專業人員操作且4小時方能取得結果，有時需重複檢驗，因此造成醫檢實驗室沉重負擔。柏勝生技快速且準確的檢測技術可協助執行大量社區回溯、診斷出無症狀患者與篩檢旅遊史人員，大幅減低醫檢人員的壓力。
(2)確認病患是否已無傳染力，符合出院標準(patients discharge)
現階段確認病患能否出院，需經PCR 3次採檢陰性。柏勝生技COVID-19血清測試可提供定量之檢測結果，瞭解病患IgG與IgM抗體之變化，可作為是否適合出院之參考依據。
科研成果創業有成，持續為世界盡一分力！
科技部自2011年起推動「研發成果萌芽計畫」，聚焦於台灣原創之頂尖前瞻技術，同步發展技術與事業，計畫目標為可商業化及值得投資的新創事業。
柏勝生技擁有創新技術、專業研發團隊並具備與國際重要衛生組織合作之經驗，當新傳染性疾病爆發時，有能力短時間內開發出相應的快速檢測產品。2016年茲卡(Zika)在各地，尤其是中南美洲地區大爆發。當時柏勝生技在國際廠商高度競爭下脫穎而出(獲選2%)，贏得美國國際開發署(USAID)「USAID-Combating Zika」研發獎金，並在預期的時間內完成產品開發與認證。另外，柏勝生技亦於2018年獲得歐盟展望2020 (Horizon 2020 SME Phase II)經費，此經費在歐洲獲選率僅3%，除給予實質補助外，同時更代表歐盟肯定柏勝生技為具有全球創新與競爭能力的新創公司。在此次各國都面臨疫情考驗之際，希望柏勝生技可成為台灣之光，並為世界盡一份力。
研究成果聯絡人
孫偉芸執行副總 柏勝生技
電話：03-318-5851 Email：jessie.sun@blusense-diagnostics.com
Press Release
8th April, 2020
MOST Germination Program:
Taiwan-Denmark International Technical Cooperation on rapid 12 minute COVID-19 diagnostic test
MOST supports new Start-up in Taiwan-Denmark international technical cooperation.
With the dawn of COVID-19, the world needs immediate testing products: BluSense successfully developed detection system which enables COVID-19 diagnostic test results be obtained within 12 minutes. BluSense completed the development of the COVID-19 serology test cartridge (ViroTrack COVID-19 IgM / IgG) in March 2020 with the support of the TEN-CHEN MEDICAL GROUP’s advice, which helped ensure the detection system could be continuously optimized.
Last week, BluSense had its preliminary clinical verification, performed at Hvidovre hospital, Denmark, with a sensitivity rate of up to 90%. The news of this exciting result was broadcast in an interview with the famous Danish news station (DR). Next week, a larger amount of clinical verification will be completed at the Italian and Denmark hospitals, which is expected to obtain EU certification (CE) in May.
BluSense Diagnostics was established in 2014 as part of a technical cooperation between Taiwan and Denmark. Subsidized by MOST Germination Program, the main shareholders are TaiAn Technologies Corp. and Quanta Storage Inc.. BluSense 's biotech R&D base is located in Copenhagen, Denmark, while the hardware and software center and equipment production are situated in Taoyuan, Taiwan. The international team, taking full advantage of Taiwan's excellent IT industry, designed and developed BluBox, a portable medical detection platform based on the Blu-ray disc drive. BlueBox works using a micro-channel biological detection disc called ViroTrack: it is extremely convenient to carry and operate, and suitable for use in airports, ports and other front-line epidemic prevention environments.
Get results in 12 minutes, and reduce the heavy burden on the medical laboratory.
BluSense overcomes many of the difficulties of existing detection systems and boasts high levels of accuracy, convenient portability and ease of operation. A sample of only one drop of blood (30 μl) is required from the test subject, and no pretreatment (such as centrifugation) is required. Test results that are quantitative, and high in both sensitivity and specificity can be obtained within just 12 minutes.
BluSense can be focused on COVID-19 serology test:
(1) Community track-backs and detection of suspected asymptomatic patients
Currently, PCR is the main detection method for COVID-19. PCR requires professional operation and 4 hours to obtain results, and sometimes repeated testing: a heavy burden on the medical laboratory. BluSense's rapid and accurate detection technology can assist in performing the en masse community tracks-backs, diagnosis of asymptomatic patients and screening of personal travel histories that are needed, greatly reducing the pressure on medical inspection personnel.
(2) Confirming whether a patient can be discharged
At the moment, in order to confirm whether a patient can be discharged from the hospital or not, three negative PCR results are required. BluSense 's COVID-19 serology test can provide quantitative test results, identify the changes of IgG and IgM antibodies in patients, and can be therefore be used as a superior reference for whether a patient is suitable for discharge.
Technology Research and Innovation Can Help!
Since 2011, MOST has been promoting a "Germination Program", focusing on the concept of “From Academia to Market: Transforming Research into Innovation”, with the innovation economy now a major government focus in Taiwan.
BluSense boasts innovative technology, a professional R&D team and experience in cooperation with international health organizations. When a new infectious disease breaks out, it has the ability to quickly develop corresponding rapid detection products to match. In 2016, it was the Zika virus, particularly in Central and South America. At that time, BluSense stood out despite a high degree of competition from international manufacturers (the selection rate was 2%), won the USAID-Combating Zika R&D bonus, and completed product development and certification within its expected timeframe. In addition, it also received funding for the European Union ’s Horizon 2020 SME Phase II in 2018 (the funding selection rate was only 3% in Europe), representing the EU ’s recognition that BluSense is amongst the most highly innovative and competitive global start-up companies. With all countries now facing the test of COVID-19, BluSense can become the light of Taiwan and do its part for the world.
Media Contact
Jessie Sun,
Executive Vice President, BluSense BioTech Co. Ltd.
TEL: +886-3-318-5851
Email：jessie.sun@blusense-diagnostics.com
Yueh-Mei Lin,
Assistant Researcher
Department of Academia-Industry Collaboration and Science Park Affairs, MOST
TEL: +886-2-2737-7240
Email：ymlin@nstc.gov.tw
