Guidance for Industry

Availability of Licensed Donor

Screening Tests Labeled for Use with

Cadaveric Blood Specimens

Comments and suggestions regarding this document may be submitted at anytime to Dockets

Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,

Rockville, MD 20852. All comments should be identified with the title of this guidance document.

Additional copies of this guidance document are available from the Office of Communication, Training

and Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Rockville, MD 20852-1448, or by

calling 1-800-835-4709 or 301-827-1800, or from the Internet at

http://www.fda.gov/cber/guidelines.htm

For questions on the content of the draft document contact Dr. Ruth Solomon, 301-827-0078.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Biologics Evaluation and Research (CBER)

June 2000
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TABLE OF CONTENTS

Note: Page numbering may vary for documents distributed electronically

I. INTRODUCTION...........................................................................1

II. BACKGROUND.............................................................................1

III. AVAILABILITY OF SPECIFICALLY LABELED TEST KITS.....................2

IV. IMPLEMENTATION......................................................................2
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Guidance for Industry1

Availability of Licensed Donor Screening Tests Labeled for Use with

Cadaveric Blood Specimens

I. INTRODUCTION

The purpose of this guidance document is to inform all establishments or persons engaged in the testing of

donations of human tissue intended for transplantation and regulated under 21 CFR Part 1270 of the

availability of two licensed donor screening tests labeled for use with cadaveric (post-mortem) blood

specimens.

II. BACKGROUND

In the Federal Register of July 29, 1997 (62 FR 40429), FDA published a final rule on human tissue

intended for transplantation. The final rule, which became effective on January 26, 1998, requires that

donor specimens be tested and found negative for the communicable disease viruses: HIV-1, HIV-2,

Hepatitis B, and Hepatitis C, using FDA licensed donor screening tests in accordance with

manufacturers’ instructions. Specifically, 21 CFR 1270.21(d) states that “FDA licensed screening tests

labeled for cadaveric specimens must be used when available.” The preamble to the rule explains that

FDA is aware of the need to clarify the appropriateness of using cadaveric specimens, i.e., a blood

specimen taken from a donor whose heartbeat has ceased, with the currently licensed test kits.

Generally, the concern has been that test results based on testing of cadaveric blood specimens that

exhibit some degree of hemolysis and/or lipemia may not be accurate. At the time of publication of the

final rule, no kits specifically labeled for cadaveric specimens were available. However, FDA states in

the preamble that once FDA approval has been given and the labeling of the test kit has been modified to

specifically indicate the use of cadaveric blood specimens, such screening tests are to be used.

Recognizing the need for specifically labeled test kits, FDA has worked with manufacturers towards

validation of assays for cadaveric specimen use. To facilitate this, FDA issued letters to test kit

manufacturers on January 12, 1995, and on May 2, 1995, which suggested a minimum protocol to

follow for such validation. Since that time, one manufacturer, Genetic Systems Corporation, has

submitted adequate validation data and has received approval for specific labeling of two screening tests

for testing of cadaveric blood specimens.

 

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This guidance document represents the agency’s current thinking and recommendations on in vitro testing of

cadaveric blood samples. It does not create or confer any rights for or on any person and does not operate to bind

FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable

statute, regulations, or both.
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III. AVAILABILITY OF SPECIFICALLY LABELED TEST KITS

On December 28, 1999, FDA approved the Genetic Systems Corporation’s Supplement to its Product

License Application for Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme-Linked

Immunosorbent Assay (ELISA) to modify the intended use of the Genetic Systems HBsAg EIA 2.0 and

the Genetic Systems HBsAg Confirmatory Assay 2.0 to include the testing of cadaveric serum samples.

On February 9, 2000, FDA approved the Genetic Systems Corporation’s Supplement to their Product

License Application for Human Immunodeficiency Virus Types 1 and 2 (Synthetic Peptide) to modify the

intended use of the Genetic Systems HIV-1/HIV-2 Peptide EIA to include the testing of cadaveric serum

samples.

These specifically labeled test kits are now available for commercial use.

IV. IMPLEMENTATION

Pursuant to 21 CFR 1270.21(d), FDA expects that testing of cadaveric samples for HIV-1, HIV-2 and

Hepatitis B should be performed using test kits specifically labeled for screening of cadaveric blood

specimens as soon as feasible, but not later than January 31, 2001. It is not necessary to retest the

cadaveric samples from donors which have already been tested prior to the implementation date.