CDC Validated System for High Throughput Detection of Influenza A (H1N1) strains from Applied Biosystems – May 2009

Materials recently listed by the US FDA under the Emergency Use Authority (EUA) program for the detection of Influenza A(H1N1) are now available from Applied Biosystems. Recent EUA releases mean that Applied Biosystems can now offer laboratories a CDC validated system for high throughput detection of new Influenza A(H1N1) strains. This integrated system forms an emerging international standard for virology and has the benefit of full technical support for both pre-developed and user developed assays.

Since the inception of the recent global alert over Influenza A(H1N1), Applied Biosystems has been working closely with public health authorities in North America and the WHO to provide bulk systems and reagents suitable for the detection of new circulating strains. Prior to the recent alert only a limited number of platforms and reagents had been validated by the US CDC and approved by the US FDA for Influenza detection. Since the outbreak was detected, a program of accelerated assessment and validation has been undertaken with the CDC to expand the range of materials recommended for Influenza A(H1N1) detection. An important part of that collaborative process has been planning and expanding manufacturing to ensure that validated detection tools be available globally.

The materials now validated and available for detection of Influenza A(H1N1) include the:

 

7500 FAST Dx Real-Time PCR System
7500 Real-Time PCR System
AgPath-ID™ One Step RT-PCR Master Mix

Applied Biosystems also has available now in quantity TaqMan® Real-Time PCR Assays fitting the recently updated CDC designs for the following targets:

Influenza A
Swine Influenza A
Swine Influenza A(H1)
RNaseP Control

To reference the EUA documents, please refer to: http://www.fda.gov/cdrh/emergency/H1N1influenza.html

To obtain the CDC developed protocols, please refer to: http://www.who.int/csr/disease/swineflu/guidance/laboratory/en/index.html

Applied Biosystems is also working rapidly to complete validation of MagMAX™ Viral Isolation systems which demonstrated excellence in providing genuine high throughput Influenza sample preparation during the recent Equine Influenza outbreak in N.S.W. This validation study includes the following components:

MagMAX™ Express-96 Magnetic Particle Processor
MagMAX™-96 Viral Isolation Kit

The Applied Biosystems service and support team can provide rapid deployment and training services should they be required.