Accession Number:

ADA553653

Title:

Advanced Developement of Leishmania Tropical Skin Test Antigen

Descriptive Note:

Annual rept. 18 Jun 2010-31 Aug 2011

Corporate Author:

ALLERMED LABS INC SAN DIEGO CA

Personal Author(s):

Report Date:

2011-09-01

Pagination or Media Count:

139.0

Abstract:

Leishmania tropica Skin Test Antigen LtSTA is lysate of microfluidized L. tropica promastigotes. The product is manufactured at a protein concentration of 0.5 mgmL. Lot consistency is established by densitometry readings of SDS-PAGE gels and delayed-type skin tests in sensitized guinea pigs. The dominant proteins in the promastigote lysate are found at 8 kDa, 20kDa, 30kDa, and 56-58 kDa of these, the 8 kDa and 56-58 kDa entities are most prominent. The 8 kDa component is believed to be ubiquitin consisting of several proteases. The 56-58 kDa component was shown to contain metalloproteases, trypanothione reductase and dihydrolipamide dehydrogenase by NanoLC-ESI-MSMS peptide sequencing technology. By densitometry, the relative amounts of the five major proteins in the lysate were as follows 8 kDa 10.1-31, 20 kDa 3.9-7.8 , 30 kDa 3.4-9.2, 56 kDa 28.9-40.1, 58 kDa 31.3-40.1. Based on a validated assay using sensitized guinea pigs, lotscontaining 0.34 mgmL to 0.61 mgmL of protein can be considered equipotent to 0.5 mgmL.

Subject Categories:

  • Anatomy and Physiology
  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE