Performance Standards
The LLNA was the first alternative test method evaluated and recommended by
ICCVAM. Based on the recommendations of ICCVAM and an independent scientific review panel, the
LLNA has been accepted by U.S. and international regulatory authorities for assessing the potential
of a substance to induce allergic contact dermatitis.
ICCVAM currently routinely develops performance standards for test methods. Peformance
standards can be used to evaluate the reliability and accuracy of proposed test methods that are based
on scientific principles similar to those of an established method and measure or predict the
same biological or toxic effect. Because the current concept of performance standards was not developed
by ICCVAM until 2003, performance standards for the LLNA were not developed during the 1998 ICCVAM
evaluation. When ICCVAM endorsed the CPSC LLNA nomination in 2007, they also decided to develop performance
standards to facilitate evaluation of modified LLNA protocols compared to the traditional LLNA.
ICCVAM has prepared draft performance standards for the LLNA and requests public comments on
this draft document. These draft test method performance
standards are proposed to evaluate the performance of LLNA test methods that incorporate specific modifications to the
measurement of lymphocyte proliferation in the traditional LLNA. These modifications focus specifically
on the measuring the incorporation of non-radioactive reagents in procedures to evaluate lymphocyte proliferation in the draining auricular
lymph nodes rather than incorporation of radioactivity (3H-thymidine), which is used in the traditional LLNA.
View document : Draft ICCVAM Performance Standards for the Murine Local Lymph Node Assay: Methods For
Assessing Lymphocyte Proliferation (Jan. 7, 2008)
[PDF]
View initial version of Draft ICCVAM Performance Standards released for public comment (Sept. 7, 2007)
[PDF]
View Federal Register notice announcing availablity of initial draft of performance standards
(Vol. 72, No. 176, pages 52130-52131, September 12, 2007) [PDF]
View Public Comments Submitted in response to FR Notice
ICCVAM will consider the report of the
March 2008 Peer Review Panel meeting and public and SACATM comments in preparing
final LLNA performance standards.
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