United States Department of Agriculture

Agricultural Marketing Service

Federal Grain Inspection Service

Criteria & Specifications May 17, 2017

Distribution: Industry Originating Office: Technology and Science Division

COVER PAGE

Design Criteria and Test Performance Specifications

for Biotechnology Rapid Test Kits

Contents

COVER PAGE �������������������������������������������������������������������������������������������������������������������������1

PREFACE���������������������������������������������������������������������������������������������������������������������������������2

1. PURPOSE AND SCOPE �����������������������������������������������������������������������������������������������������

2. SUMMARY OF TEST KIT EVALUATION PROCESS ����������������������������������������������������������

3. PROGRAM CONTACT INFORMATION�������������������������������������������������������������������������������

4. DEFINITIONS ����������������������������������������������������������������������������������������������������������������������

5. TEST KIT EVALUATION REQUIREMENTS�������������������������������������������������������������������������

6. CERTIFICATE OF PERFORMANCE ����������������������������������������������������������������������������������

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Washington, DC 20250-9410, or call (202) 720-5964 (voice and TDD). USDA is an equal employment opportunity 

employer.
Design Criteria and Test Performance Specifications 

for Biotechnology Rapid Test Kits

Effective May 17, 2017

Page 2

PREFACE

Design Criteria and Test Performance Specifications for 

Biotechnology Rapid Test Kits

Effective Date: 5/17/2017

United States Department of Agriculture

Agricultural Marketing Service

Federal Grain Inspection Service

Technology and Science Division

Approved by: /s/ Tandace A. Bell, Ph..   Dae:  ____5/17/2017___

 Acting Deputy Director 

 Technology and Science Division 
Design Criteria and Test Performance Specifications 

for Biotechnology Rapid Test Kits

Effective May 17, 2017

Page 3

1. PURPOSE AND SCOPE 

To meet the grain industry’s demand for accurate and reliable qualitative testing for 

genetically engineered (GE) traits in grains and oilseeds, test kit manufacturers have 

asked the United States Department of Agriculture’s Federal Grain Inspection Service 

(FGIS to maintain a program to verify test kit performance claims and subsequently 

issue Certificates of Performance (COP) for test kits meeting these claims. In response 

to this request, FGIS has established a program for verifying the performance of these 

qualitative rapid test kits

2. SUMMARY OF TEST KIT EVALUATION PROCESS 

The Rapid Test Kit Performance Evaluation Program established by FGIS is a basic four 

step process where:

a. The rapid test kit manufacturer submits a data package supporting their claim

b. FGIS staff reviews the data submitted by the manufacture

c. If FGIS determines the data package is complete and the claims of the rapid tes

kits are supported by the data, FGIS conducts an in-house performance verification 

of the rapid test;

d. If the manufacturer’s claims are verified by FGIS’s in-house performance testing, 

a Certificate of Performance (COP) is issued to the manufacturer for the rapid test.

The COP will be valid for three years from its date of issuance. Renewal of a COP

requires a full submission and evaluation

If the test kit fails to meet all of the criteria specified herein, the test kit can be 

resubmitted after a three-month waiting period. When the test kit is resubmitted,

the applicant must state the corrective action that was taken to bring the test kit into 

conformance with FGIS requirements

3. PROGRAM CONTACT INFORMATION

For any questions regarding the program, contact the Biotechnology Laboratory 

Program Leader, Dr. Brian Beecher by email or via telephone at: Brian.S.Beech

usda.gov, 816-891-0453. Submission packets should also be sent to the email addres

above

FGIS will assess a fee for evaluating the test kit, including all documentation reviews.

Payment is required within thirty days of the invoice date
Design Criteria and Test Performance Specifications 

for Biotechnology Rapid Test Kits

Effective May 17, 2017

Page 4

4. DEFINITIONS

Genetically Engineered Grains and Oilseeds. Grains and oilseeds that are products

of modern biotechnology (genetic engineering) to modify agronomic and/or quality 

characteristics

Limit of detection. The lowest concentration of a genetically engineered protein/or

DNA that can be reliably detected by a rapid test kit. This concentration will be specified 

by the manufacturer upon submission.

Fortified Samples. Samples of grain or oilseeds containing a predetermined

concentration of genetically engineered grain due to the addition of known quantities of 

the corresponding genetically engineered grain or oilseed, as applicable

5. TEST KIT EVALUATION REQUIREMENTS

Manufacturer Information

a. Limit of Detection

The manufacturer is required to submit data that supports the claims they make 

regarding the performance of the rapid test kit. The test kit must reliably detect

the presence of genetically engineered material in the grain/oilseed at the limit of 

detection claimed by the manufacturer

b. General Information

To submit a rapid test kit to FGIS for performance verification, the manufacturer 

must submit the following information to the Biotechnology Laboratory Program 

Leader

• Manufacturer name and address

• Manufacturer point of contact

• Telephone number

• Fax Number

• E-mail address

• Test Format: Lateral slow strip, microtiter well assay, or other (specify)

• Matrix: corn, soybeans, other (specify)

• Protein/DNA detected and the corresponding trait 

• Limit of detection

• User instructions for the rapid test kit
Design Criteria and Test Performance Specifications 

for Biotechnology Rapid Test Kits

Effective May 17, 2017

Page 5

c. Manufacturer Data Submission

To support claims with respect to the particular rapid test kit, the manufacturer is 

required to submit the following data to FGIS:

• Control Samples

One hundred fifty-six (156) independent analyses performed using thirteen 

(13) different negative samples tested across three (3) manufacturing lots, at 

four (4) replicates per sample. A minimum of one hundred fifty three (153) of 

the test results must be negative for the genetically engineered material of 

interest

• Fortified Samples

One hundred fifty-six (156) independent analyses performed using thirteen 

(13) different samples fortified at the claimed detection threshold. Samples 

will be tested across three (3) manufacturing lots, at four (4) replicates per 

sample. A minimum of one hundred fifty three (153) of the test results must be 

positive for the genetically engineered material of interest

d. Performance of Rapid Test at 18° C and 30° C

Data must be provided demonstrating reliable performance of the test at 18° C 

and 30° C if the detection apparatus is not temperature controlled. Samples,

equipment, and testing materials must be equilibrated at the testing temperature 

for one hour prior to conducting the analyses

(1) Control sample analyses at 18° C

Twenty (20) independent analyses. All test results must be negative for the

genetically engineered material of interest.

(2) Fortified sample analyses at 18° C.

Twenty (20) independent analyses. All test results must be positive for the

genetically engineered material of interest.

(3) Control sample analyses at 30° C

Twenty (20) independent analyses. All test results must be negative for the

genetically engineered material of interest.

(4) Fortified sample analyses at 30° C.

Twenty (20) independent analyses. All test results must be positive for the

genetically engineered material of interest
Design Criteria and Test Performance Specifications 

for Biotechnology Rapid Test Kits

Effective May 17, 2017

Page 6

e. Cross-reactivity with Other Genetically Engineered Proteins/DNA.

For protein-based tests, data shall be provided from five (5) independent tests 

of all other genetically engineered proteins in commercial production in the U.

demonstrating that the test is specific for the protein of interest, but not necessarily 

trait-specific. All tests must be negative for test samples that do not contain the 

target protein. If multiple events express the same protein, these events and their

corresponding protein expression levels must be indicated on the submission data 

package and in the final instructions included in the manufactured test kit. 

f. FGIS Review and Performance Verification

Upon receipt of the data submission from the manufacturer, FGIS will:

Review the data submission for completeness and compliance with FGIS

performance standards as stated above and will advise the manufacturer that the 

test meets or did not meet the performance specifications. 

If the test kit meets all performance specifications, FGIS will contact the 

manufacturer and identify a mutually agreeable date for the manufacturer to train 

FGIS staff in the operation of the test. While training of FGIS staff is advisable, it

can be waived at the manufacturer’s discretion

Reference material (whole kernel or seed) is required to perform test kit 

verification. The test kit manufacturer will be asked to obtain negative material 

as well as positive reference material from the appropriate life science company 

in order to verify the claims of the kit. FGIS reserves the right to characterize the

integrity of the provided materials by appropriate laboratory analysis

The performance verification will consist of the FGIS analysis of control and 

fortified samples as specified below:

(1) Control Samples

One hundred fifty-six (156) independent analyses performed using thirteen 

(13) different negative samples tested across three (3) manufacturing lots, at 

four (4) replicates per sample. A minimum of one hundred fifty three (153) of 

the test results must be negative for the genetically engineered material of 

interest. (2) Fortified Samples

 (2) Fortified Samples

One hundred fifty-six (156) independent analyses performed using thirteen 

(13) different fortified samples. Samples will be fortified by FGIS personnel 

at the manufacturer’s stated limit of detection. Samples will be tested across

three (3) manufacturing lots, at four (4) replicates per sample. A minimum

of one hundred fifty three (153) of the test results must be positive for the 

genetically engineered material of interest.

If the test kit fails the performance verification, the test kit must be resubmitted with 

new supporting performance data
Design Criteria and Test Performance Specifications 

for Biotechnology Rapid Test Kits

Effective May 17, 2017

Page 7

6. CERTIFICATE OF PERFORMANCE

A rapid test kit that successfully demonstrates conformance with the manufacturer’s 

claims will be awarded a Certificate of Performance. The Certificate of Performance 

automatically expires three (3) years from the date of issue. The manufacturer will be

required to resubmit new performance data to FGIS prior to the expiration date to have 

the Certificate of Performance renewed for an additional three years. 

FGIS reserves the right to rescind the Certificate of Performance if:

• The manufacturer fails to notify FGIS of changes or alterations to the test kit

• The test kit is found to produce invalid results identified by users, or through some 

other program