新加坡科技研究局和陈笃生医院29日联合发布的消息说，其研究人员合作研发出一种禽流感病毒快速检测试剂，能测出由H5N1型禽流感病毒基因组改变而生成的50多种变异毒株。这种新试剂只需从人的口腔和鼻腔提取样本，可在约两小时内一次性完成测试，其准确率接近100%。
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图1 新加坡产H5N1禽流感诊断试剂盒
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图2 Dr Masafumi Inoue（新加坡科技研究局）和 Dr Timothy Barkham（陈笃生医院）
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据悉，目前普遍采用的检测方法只对H5N1型禽流感病毒部分变异毒株有效。参与此项研发的新加坡科技研究局专家说，新方法简化了对禽流感病毒变异毒株的检测，可用一种试剂通过“实时荧光定量反转录聚合酶链反应”检测这一病毒所有已知变异毒株，这对于及时测出发生抗药性变异的禽流感病毒尤为重要。
上述两家新加坡机构说，这种新试剂已通过东南亚一些医院临床试验，新加坡科技研究局下属机构已允许新加坡某企业在部分地区推广这种试剂。
更多阅读：
Made-In-Singapore H5N1 Bird Flu Diagnostic Kit – Detects All Known Strains of H5N1 Virus With A Single Test
Licence agreement signed between local SME, AITbiotech and A*STAR to market the test kit will directly benefit public healthcare sector in the fight against infectious diseases
1. The close collaboration between scientists from the Experimental Therapeutics Centre (ETC) under the Agency for Science and Technology Research (A*STAR) and clinicians from Tan Tock Seng Hospital (TTSH) has enabled the successful development of the most comprehensive and rapid H5N1 bird flu test kit available to date. With this highly advanced kit, doctors can now rapidly detect all existing strains of the H5N1 viruses in a single test with almost 100% accuracy, within a few hours. This is a big boost to public healthcare system and a great stride forward in pandemic preparedness against this highly infectious disease worldwide.
2. The bird flu virus, scientifically termed as the Avian Influenza[1] virus, is usually lethal to the birds and normally does not transmit to humans. However, highly lethal and contagious strains like H5N1 Avian Influenza A virus that can ‘jump’ from birds to human have been reported to cause serious infections and even death rates as high as 60% in infected patients[2]. Although anti-viral treatment is available, the potential for H5N1 bird flu virus to spark a pandemic remains a serious threat to public health as most humans do not have immunity to the H5N1 virus. Therefore, to successfully curb the spread of the disease during an outbreak, accuracy and speed of detection on the type of H5N1 virus is of essence for effective infection control intervention and patient management.
3. The current gold standard for H5N1 detection recommended by the World Health Organization[3] (WHO) is only able to detect three out of the 10 distinct genetic groups (clades 1, 2 and 3). To detect all existing strains of H5N1 with the WHO detection method would not be possible. The made-in-Singapore H5N1 test kit, which is more accurately known as the H5N1 real-time Reverse Transcription Polymerase Chain Reaction (RT-PCR) assay, is the only detection kit currently available on the market that can accurately and rapidly detect all known strains[4] of the H5N1 Avian Influenza A virus in a single test within a matter of hours.
4. Co-developed by Dr Masafumi Inoue, a Senior Research Scientist and Project Director of Technology Development from ETC and Dr Timothy Barkham, a senior consultant of Laboratory Medicine from TTSH, this newly launched H5N1 test kit has been clinically validated by several hospitals in Southeast Asia.
5. “We are excited to be able to contribute to the fight against H5N1 virus with our expertise and know-how. Our technology has greatly simplified and accelerated the process of detection and identification of new H5N1 variants. Such information is especially critical when the virus mutates to become more dangerous, such as in drug resistance.” said Dr Inoue. (See video release on interview with Dr Inoue http://www.youtube.com/watch?v=OY_DDU2RwEY)
6. To enhance its usability, this new H5N1 test kit is also purposefully designed to be compatible with the previously launched “4-plex” Influenza diagnostic kit[5]. The latter is already adopted for use by several regional hospitals in Thailand. Using such multiplex assays enables simultaneous detection and differentiation of the different types[6] of influenza infection in a single test, which will save hospital labs and clinicians significant time and cost.
7. “While there have not been any reported H5N1 cases in Singapore, this mutating subtype of influenza virus type A continues to be a concern. The ability to detect and characterise influenza strains remains important in the management of the disease. With this latest H5N1 assay, we can easily combine it with our previous 4-plex Influenza kit to differentiate which strain of Influenza is present with one test, giving a definite diagnosis and faster turnaround for our patients and our colleagues in infection control and public health,” said Dr Barkham.
8. Local Small and Medium Enterprise (SME), AITbiotech Pte Ltd, a regional provider of genomic services and molecular diagnostics kits, has recently signed a licence agreement with Exploit Technologies Pte Ltd (ETPL), the technology transfer arm of A*STAR, to market this H5N1 kit regionally.
9. “The new H5N1 test kit from A*STAR is a significant addition to AITbiotech’s existing portfolio of products for Influenza virus screening and surveillance. In light of the recent H5N1 outbreak in this region, we believe that this test can play a vital role for governments and public health institutions to effectively fight and control the outspread of any H5N1 virus”, said Mr Alex Thian, Founder and Chief Executive Officer of AITbiotech.
10. Previously, AITbiotech has acquired several other molecular diagnostic licenses from ETPL for swine flu mutation surveillance and for multiple pathogens detection, including Dengue, Chikungunya and Mycobacterium Tuberculosis.
11. “Licensing these highly sophisticated assays from A*STAR has given AITbiotech a springboard into the highly competitive market of Molecular Diagnostics. With our expanded capabilities, we are now able to provide a comprehensive suite of diagnostic services for a range of infectious diseases to the research, healthcare and biomedical industries in Singapore and Asia,” added Mr Thian.
12. “This collaboration between A*STAR, TTSH and AITbiotech is a great example of how public and private sectors can partner to drive impact in Singapore’s healthcare and biomedical industries. We remain committed in our role to transfer A*STAR technologies to help SMEs like AITbiotech stay competitive by delivering products with direct societal benefits,” said Philip Lim, CEO of ETPL.
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