VetMAX-Gold USDA-Licensed Solutions

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The USDA Animal and Plant Health Inspection Service (APHIS) regulates veterinary biologics (vaccines, bacterins, antisera, diagnostic kits, and other products of biological origin) to help ensure that the veterinary biologics available for the diagnosis, prevention, and treatment of animal diseases are safe and effective. The APHIS Center for Veterinary Biologics (CVB) carries out this work, focusing on enforcement of the Virus Serum Toxin Act.

Thermo Fisher Scientific animal health products have been at the forefront of recent advances in production animal diagnostics, and are some of the leading modern diagnostic tools to veterinary laboratories around the world.

Our vision is to provide comprehensive solutions to help diagnose farm animal health issues more quickly and accurately than ever before. To learn more about our USDA-licensed diagnostic solutions for such diseases as tritrichomonas foetus, bovine viral diarrhea virus and swine influenza virus please download our product flyer.

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Thermo Fisher Scientific hosted an event attended by state veterinarians that included a presentation explaining the USDA licensure process, as well as the production and performance criteria that veterinary diagnostic test kits must satisfy to earn a USDA license. See below to view the presentation video.

Mary Anne Williams
Senior Manager, Regulatory Affairs
Thermo Fisher Scientific

• Sensitive, qualitative real-time PCR assay yielded up to 100% sensitivity in field trials
• Detection kit can be used to test pools of up to 5 samples with 96.16% accuracy
• Helps improve reproducibility across laboratories and across states
• Simplifies lab workflow and is easily automated for high-throughput processing
• USDA oversees the quality control process and the release of every batch

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• Approved for use with single samples or pooled samples of up to 24 animals
• Proven repeatability (CV <3.3%) and reproducibility (CV <2.4%) in field studies
• Rapid and cost-effective method for detection of BVDV, with results in ~1.5 hr
• Workflow minimizes sample handling and helps reduce sample cross-contamination
• USDA oversees the quality control process and the release of every batch

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• Validated for use with single cattle feces samples or pooled samples of up to 5 animals
• Demonstrated high sensitivity (96.2%) and specificity (96.4–100%) in USDA validation study
• Proven repeatability (100%) and reproducibility (100%) in USDA validation study
• Simple workflow tailored for MAP detection that is easily automated for high-throughput processing
• Includes Applied Biosystems™ VetMAX™ Xeno™ Internal Positive Control to help prevent false signals from nonspecific targets
• Routine monitoring of our manufacturing site for compliance with production and quality system guidelines

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• SIV Detection Kit sensitivity of 98.4% and specificity of 99.1%
• SIV Subtyping Detection Kit sensitivity of 98.2% and specificity of 100%
• Real-time PCR technology helps improve reproducibility via assay standardization
• Genomic targeting helps reduce risk of false negatives caused by genomic mutation
• Kits are designed to provide rapid detection of SIV RNA extracted from porcine nasal swabs
• USDA authorized representatives oversee the quality control process and the release of every batch

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• Designed to screen 3 genomic regions to detect AIV with exceptional sensitivity and specificity
• A simplified, validated workflow helps labs streamline their testing process
• Real-time PCR technology enables greater testing consistency and reproducibility
• USDA oversees the quality control process and the release of every batch

Find out more ›  Download product flyer ›