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