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  • 深圳褀氏-全自動分子免疫學體外診斷專家

    重要消息:首款新型冠狀病毒重組抗原抗體結合動態檢測試劑盒,作為唯一一款生化全自動通用型試劑盒進入國家商務部出口“白名單”

    2020-06-29

    日前,褀氏生物自主研發的新冠抗體檢測試劑,進入了中國醫藥保健品進出口商會的白名單,同時也獲得多個國家的準入資質,其中血清總抗體檢測法作為WHO推薦的方法學,適合大規模人群快速自動化檢測。褀氏為繼續支持國際社會抗擊疫情,貢獻一份中國力量!

    The two types of novel coronavirus antibody test reagents independently developed by Kisshealth's have entered the "White List" of China Chamber of Commerce for Import & Export of Medicines & Health Products. At the same time, we have also won access qualifications from a number of countries. As a methodology recommended by WHO, Serum total antibody method is suitable for rapid and automatic detection of large-scale population. Kisshealth contributes to China's efforts to continue supporting the international community in the fight against the epidemic.

    在全球疫情持續蔓延的特殊時期,為更有效支持國際社會共同應對全球公共衛生危機,現就進一步加強防疫物資質量監管、規范出口秩序。2020425日,國家商務部、海關總署、國家市場監督管理總局發布公告2020年第12號《關于進一步加強防疫物資出口質量監管的公告》。

    In order to more effectively support the international community's joint response to the global public health crisis at this particular time when the global epidemic continues to spread, it is important to further strengthen the role of the international community in addressing the global public health crisis. Strengthening quality control of epidemic prevention materials and regulating export order. On April 25, 2020, the Ministry of Commerce, the General Administration of Customs, the National The General Administration of Market Supervision and Administration issued Announcement No. 12 of 2020 “Announcement on Further Strengthening the Quality Control of Export of Epidemic Prevention Materials” .

    褀氏生物入選中國醫藥保健品進出口商會,新冠試劑出口“白名單”

    Kisshealth was selected on the "White List" by the China Chamber of Commerce for Import &Export of Medicines & Health Products

    新冠疫情爆發以來,褀氏生物迅速組織公司研發力量,針對新型冠狀病毒啟動攻關,經過研發團隊不懈努力,克服一切困難,順利完成了新型冠狀病毒總抗檢測試劑的開發。

    Since the outbreak of the novel coronavirus epidemic, Kisshealth has rapidly organized its research and development team to tackle the novel coronavirus and overcome all the difficulties to successfully complete the development of the novel coronavirus total antibody test.

    褀氏的新冠病毒檢測試劑盒既適合單獨診所進行測試,也適合大型醫院。適合獨立診所使用的是膠體金法,適合大規模人群篩查的是免疫比濁法。

    Kisshealth's novel coronavirus test kit are suitable for testing not only in individual clinics, but also in large hospitals. Colloidal gold method issuitable for individual clinic, and immune turbidimetric method is suitable forlarge-scale population screening.

    新型冠狀病毒檢測試劑盒(膠乳增強免疫比濁法

    SARS-CoV-2 IgM/IgG AntibodiesTestKit(Latex particle-enhanced turbidimetric immunoassay)

    免疫比濁法檢測試劑盒是自動化方法學,可配套醫院現有自動化設備,可應用于世界各大品牌的生化儀器,如貝克曼、羅氏、雅培等等,降低了醫護人員檢測過程中被感染的風險,可以實現上千人份同時測試,適于大型三甲醫院至基層醫療機構進行新型冠狀病毒的大規模篩查檢測。測試速度可達2000測試/小時,重復性<3%,批間差 <5%,適用于疑似患者隔離區、確診患者隔離區、三甲醫院發熱門診、基層醫院、社康門診等多種不同的復雜應用場景。

    The immunoturbidimetric test kit is an automatic methodology, which can be equipped with existing automatic equipment in hospitals, and can be applied to biochemical instruments of major brands in the world, such as Beckman, Roche, Abbott, etc., reducing the risk of healthcare workers being infected during testing, and can achieve thousands of simultaneous testing, which is suitable for large-scale screening and testing of novel coronavirus from large-scale third-class hospitals to primary care institutions. The test speed can reach 2000 tests per hour, reproducibility<3%, inter-batch variation <5%. It is suitable for a variety of complex application scenarios, such as isolation area for diagnosed patients, fever clinics in tertiary hospitals, primary hospitals, and community health clinics.

    新型冠狀病毒檢測試劑盒(膠乳增強免疫比濁法)的優勢:

    1、擁有自主研發膠乳抗原偶聯技術、液相膠乳增強免疫比濁法體外診斷技術;

    2、樣本為血液,來源靈活,降低醫護人員的暴露感染風險,極大緩解臨床診療壓力;

    3、采用目前國內最快的液相方法學,突破對人員場所的限制,縮短檢測用時,操作便捷;

    4、適用面廣泛,可應用醫療機構廣泛,與醫院全自動生化分析儀配套使用,對于廣大基層醫療機構來講經濟負擔輕、成本可控、兼容性強;

    5、可與核酸檢測、CT檢查配套進行精準診斷,實現疑似患者的快速診斷和大規模密切接觸人群的快速篩查,防止疫情擴散。

    生化檢測及其他指征進行綜合判讀、聯合應用,更能有助于提高疾病的檢出率,盡可能地找出確診患者,更有利于疫情的控制。

    Advantages of novel coronavirus test kit (latex enhanced immune turbidimetry):

    1. It has self-developed latex antigen coupling technology and liquid phase latex enhanced immunoturbidimetry In-vitro diagnosis technology;

    2. The sample is blood, the source is flexible, reduce the risk of exposure and infection of medical staff, greatly relieve the pressure of clinical diagnosis and treatment;

    3. It adopts the fastest liquid phase method, breaks through the restrictions on personnel places, shortens the detection time and is easy to operate ;

    4. It can be widely used in medical institutions, and it is used in combination with the hospital automatic biochemical analyzer. For the majority of primary medical institutions, it has the advantages of light economic burden, controllable cost and strong compatibility;

    5. It can be used for precise diagnosis in combination with nucleic acid detection and CT examination to realize rapid diagnosis of suspected patients and rapid screening of large-scale close contact population, so as to prevent the spread of the epidemic.

    新型冠狀病毒檢測試劑盒(膠體

    Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2)IgM/IgG Test Kit(Immunochromatography)

    近期,國內連續幾天出現本土新增確診病例,一方面提醒著我們要倍加珍惜來之不易的防控成果,另一方面也為我們敲響了警鐘。根據世界實時統計數據顯示,截至北京時間6171527分,全球新肺炎累計確診病例超過827萬例,其中海外達到8181606例,累計死亡病例超過44.15萬例,達到429758例。

    Recently, there have been new confirmed cases in China for several consecutive days, which on the one hand reminds us to cherish the hard-won results of prevention and control, on the other hand, it also rings the alarm for us. According to real-time world statistics, as of 15:27 on June 17, Beijing time, the cumulative number of confirmed cases of COVID-19 worldwide exceeded 8.27million, of which 8181606 were overseas, and the cumulative number of deaths exceeded 441500, reaching 429758.

    面對國際疫情,褀氏生物承擔起企業應有的責任和社會擔當,謹記責任勇于擔當,時刻為疫情抗爭貢獻自身力量,褀氏所研發的新冠檢測試劑將為全球抗疫戰構筑抵御病毒的衛生防線。褀氏用行動踐行著構建人類命運共同體的莊嚴承諾。

    In the face of the international epidemic, Kisshealth assumes its due responsibility and social responsibility, bear in mind that it has the courage to take responsibility, always contribute its own strength to the fight against the epidemic. Kisshealth will build a health line of defense against the virus for the global anti-epidemic war. With actions, Kisshealth fulfills the solemn promise of building a community with a shared future for mankind.



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