Applied Biosystems, an Applera Corp business, today November 9 announced a comprehensive offering for responding to the avian influenza threat, that includes standardised influenza detection kits for surveillance, the availability of ongoing sequencing information of the influenza virus, and provision of access to a global influenza genome database.
The purpose of these kits is to assist public health officials and researchers in evaluating and monitoring outbreaks of avian influenza. This offering is part of a broader Applied Biosystems international initiative to ensure that detection kits and up-to-date genomic data are available for priority epidemiology studies related to infectious disease threats.
As outlined in the US government’s National Strategy for Pandemic Influenza issued on November 1, 2005, surveillance and detection are a critical component in providing continuous situational awareness to ensure maximum protection for the public.
The creation of a worldwide surveillance system capable of rapidly and reliably tracking the mutation and presence of influenza strains is a necessary first step in the fight against outbreaks. Applied Biosystems outlined the following key components of its global infectious disease surveillance initiative:—Standardised Surveillance and Detection Infrastructure—Detailed Genetic Analysis—Real-Time Surveillance and Validated Influenza Detection Kits—Global Influenza Information Availability—Applied Biosystems Infectious Disease Surveillance System .
“The US government and public health organisations, such as the World Health Organisation, have made clear that the world must develop a robust global infectious disease surveillance infrastructure to prevent pandemics from emerging,” said Mark P. Stevenson, Division President of Applied Markets for Applied Biosystems.
“Recognising the importance of public and private partnerships to fulfill this mission, Applied Biosystems is marshalling its expertise in science, engineering, and manufacturing to meet this need, beginning with the launch of specific solutions to address the avian influenza threat,” added Christopher P. Melancon, director of BioSecurity, Applied Markets Division of Applied Biosystems.
Avian Influenza Programme Details Applied Biosystems, along with key partners in the public health community, is rolling out a comprehensive surveillance response to the avian influenza threat to help public health agencies identify H5N1 outbreaks as well as track the ongoing genetic changes of virulent influenza strains.
This response includes the following components: Standardised Surveillance and Detection Infrastructure—Detailed Genetic Analysis Sequencing is an important technology for understanding genetic changes in the influenza virus. Epidemiologists can use genetic sequence information to track the evolution of the virus and the spread of the disease throughout animal and human populations.
Applied Biosystems has solicited guidance from the World Health Organisation (WHO) headquarters and Collaborating Centres for Influenza to provide standardised genome sequencing protocols and technology to key public health laboratories around the world. Based on this guidance, Applied Biosystems is designing sequencing protocols and kits for distribution by March 2006, through the WHO Collaborating Centres for Influenza in Melbourne, Australia.
Based on Applied Biosystems’ industry-leading sequencing technology, viral genome sequencing systems are capable of sequencing and analysing the entire influenza genome, including the dangerous H5N1 subtype.
Over 12,000 of Applied Biosystems’ genetic analysers, such as the 3130 Genetic Analyser product line and 3730 DNA Analyser product line, are installed in more than 4,500 global locations.—Real-Time Surveillance and Validated Influenza Detection Kits Genetic-based detection, based on real-time PCR technology, represents the state-of-the art in surveillance technology to determine whether the virus is present in laboratory samples.
Applied Biosystems has a global installed base of real-time PCR systems, including over 100 systems currently utilized by the US national public health network, which could be called upon to contribute towards the US government’s national preparedness for avian influenza.
Applied Biosystems has developed a TaqMan (R) Influenza A/H5 Detection Kit to detect the presence of the H5 subtype, including H5N1, in human and animal samples in less than two hours. The kit, which is designed to run using standardised protocols on Applied Biosystems real-time PCR systems, is currently being tested and optimized for maximum sensitivity against viral samples of the H5N1 subtype in Hong Kong.
“The tendency of influenza viruses to undergo frequent genetic adaptation necessitates constant monitoring,” said Dr Leo L.M. Poon, Associate Professor of the Department of Microbiology at the University of Hong Kong. “By testing these avian flu virus detection kits with a broad range of historical and recently isolated samples, we can gain confidence that they will reliably detect and identify this rapidly changing virus.” “Genetic-based detection is one of the most reliable approaches for detecting the presence of harmful pathogens, including the dangerous Influenza H5N1 subtype,” said Ian Barr, Ph.D., deputy director, World Health Organisation Influenza Collaborating Centre, Melbourne, Australia.
“We are pleased with the initiative that Applied Biosystems has demonstrated in supporting the global influenza scientific community to address this critical public health requirement and look forward to the roll-out of these new assays.”
Further confirmation testing of the detection kits will be conducted at reference laboratory sites around the globe, including sites in Germany, Italy, Slovenia, Kenya, Thailand, Japan, and Australia. Applied Biosystems expects to ship these kits to select laboratories before the end of 2005, with broad availability in early 2006.
To ensure availability of the kits in the event of an outbreak, Applied Biosystems intends to stockpile materials in the United States, United Kingdom, and Japan to enable a more rapid response to kit production and distribution. Global Influenza Information Availability Applied Biosystems intends to purchase non-exclusive licenses (subscriptions) for the analysis software associated with the Los Alamos National Laboratory (LANL) Influenza Sequence Database (http://www.flu.lanl.gov/).
These licenses will give foreign governments and/or public health laboratories located in high risk areas of the world access to the analysis software. To ensure that there is maximal sharing of scientific information about influenza viruses between governments, scientific entities, and the private sector, laboratories using Applied Biosystems’ standardised sequencing platform will be encouraged to submit influenza genome sequence information to the LANL database, GenBank(R), the National Institutes of Health (NIH) sequence database, or other publicly accessible databases. “Los Alamos National Laboratory is keenly interested in partnering with Applied Biosystems and other partners to ensure that our scientific expertise and analysis tools are available in the global efforts to combat pandemic pathogen outbreaks,” said Allen Morris, Ph.D., Licensing Executive at Los Alamos National Laboratory.
Applied Biosystems Infectious Disease Surveillance System Moving beyond the specific response to the avian influenza threat, Applied Biosystems has developed a standardised system for surveillance and detection of a broad range of infectious diseases for epidemiological use. The system includes:—ABI PRISM(R) 6100 Nucleic Acid PrepStation: Instrument module for collecting and preparing human and animal samples for testing on the real-time PCR system.—Applied Biosystems 7900HT Real-Time PCR System with TaqMan(R) Low Density Array Capability: High throughput system for identifying and characterizing specific pathogens.—Standardised Protocols: Pathogen-specific protocols to ensure that tests are reproducible and render reliable results. Applied Biosystems Global Infectious Disease Surveillance Initiative.