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The world leader in serving science
April 15th, 2015
Demystifying USDA licensure and its importance to diagnostic testing
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APHIS regulates veterinary biologics (vaccines,
bacterins, antisera, diagnostic kits, and other
products of biological origin) to ensure that the
veterinary biologics available for the diagnosis,
prevention, and treatment of animal diseases are
pure, safe, potent, and effective. This work is
done by APHIS' Center for Veterinary Biologics
(CVB) and is centered around enforcement of the
Virus Serum Toxin Act
Regulatory Overview
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Regulatory Scope
Sample Preparation Instrumentation &
Software
Test Kits
NOT REGULATED NOT REGULATED REGULATED
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Three focus areas for USDA approval for
Veterinary diagnostics
• Production Facility
• Test Kit Performance
• Test Kit Production and Commercialization
VS Memorandum 800.73: General
Requirements for Immunodiagnostic Test Kits
for the Detection of Antibody or Antigen
Regulatory Overview
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•Plot Plans, Blueprints, and Legends
•Fraction List/Risk Assessment
•Personnel Qualifications
•Serial Release
•Adverse Event Reporting
•Facility Inspections
Facility Requirements
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Performance Requirements
•Field Sensitivity and Specificity,
•Field Repeatability and Reproducibility,
•Analytical Studies (i.e., Limit of Detection,
Inclusivity, Exclusivity, etc.), and
•Stability
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Outline of Production
• Intended Use, Limitations
•Raw materials produced in house or sourced
from qualified suppliers
•Standardized/Validated manufacturing
processes
•Serial Release criteria
•Test Kit Configuration
•Product Labeling
Production and Commercialization
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USDA Veterinary Biologics
Establishment License
USDA Veterinary Biologics
Product License
USDA Facility and Product Licenses
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USDA Licensed/Permitted Products are:
• Manufactured in an inspected, approved facility in a
controlled environment by qualified operators,
• Manufactured with qualified raw materials using validated
processes, monitored for consistent serial-to-serial
performance,
• Validated in the laboratory and in the field and found to be
suitable for the intended purpose,
• Reviewed by CVB prior to serial release,
• Reviewed by CVB for approval of material/process changes,
and
• Subject to post market surveillance.
In Summary
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Laboratory Landscape
• Laboratory accreditation and validation criteria
are evolving
•Additional documentation is needed to meet
accreditation requirements
•USDA approved diagnostic products can help
fulfill accreditation and quality standards
requirements
•Thermo Fisher is partnering with laboratories to
utilize our USDA licensed tests in standardized
workflows
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AAVLD Laboratory Accreditation Needs
•Before guidelines were considered, test
development and validation was not
standardized
•New AAVLD Laboratory Technology Committee
Guidelines outline standardization requirements;
how this is achieved is left to the laboratory
directors
USDA licensed test kits simplifies the effort to
comply with accreditation requirements
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Accreditation Guideline Compliance
Should the Lab
Offer a New Test? Justification/ Scope
Application /Feasibility
Optimization
Test
Performance
measures Range of Linearity
LOD, Precision (R/R)
Diagnostic S/S
Ongoing
Assessment of
Assay Function /
Re-validation
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Current Menu of rRT-PCR
Requires Longitudinal Management
Implementation a
laborious process
How can we help
our customers?
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Potential Implications:
Service
Test
Performance
Measures
Research
Service
Current
Near
Future
Test Performance
Measures
Laboratory
Technology
Committee
Guidelines
Research
© 2014 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo
Fisher Scientific and its subsidiaries unless otherwise specified.
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Value of USDA Licensed Tests
Service
Test
Performance
Measures
Research
Service Test Performance
Measures
Research
USDA Licensed Tests
Recommended