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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