Comparison of several control standard endotoxins to the National Reference Standard Endotoxin--an HIMA collaborative study

Abstract

A collaborative study, initiated under the auspices of the Health Industry Manufacturers Association (HIMA), was designed to establish the relationship of Escherichia coli 055:B5 endotoxin (the control standard endotoxin of HIMA and the Food and Drug Administration's Office of Medical Devices) to the U.S. National Reference Standard Endotoxin and to two internationally used control standard endotoxins. By using two Limulus amoebocyte lysate test systems, it was established that the E. coli 055:B5 endotoxin lot originally used by HIMA and the Office of Medical Devices to establish Limulus amoebocyte lysate release test criteria for pyrogen testing of medical devices contains approximately 4.5 endotoxin units (EU) per ng. Thus, the 1.0-ng/kg endotoxin dose limit currently established for medical devices is approximately the same as the 5.0-EU/kg endotoxin limit (on an activity basis) established by several other Food and Drug Administration agencies for human and animal parenteral drugs and biological products.

Lipopolysaccharide-binding protein (LBP) reverses the amyloid state of fibrin seen in plasma of type 2 diabetics with cardiovascular co-morbidities

“…A question that can arise is why we did not measure the amount of LPS in the plasma. LPS is typically not a molecularly defined substance, and its activity is sometimes reported in ‘endotoxin units’ (EU); this is based on a standard taken from an E. coli O55:B5 strain; an approximate relationship is that 1 ng endotoxin ~10 EU 73 , 102 . The only assay currently available is the Limulus amoebocyte lysate assay; however, its use in the estimation of LPS in blood is not considered especially reliable 103 – 107 .…”

Dodecin as carrier protein for immunizations and bioengineering applications

“…MtDod-PAS-Pep3 and Dod-PAS-Pep6 contained the highest amount of endotoxin with 73 EU/mg and 55 EU/mg, respectively; all other samples showed values less than 30 EU/mg (average of all constructs 30 ± 23 EU/mg). Since less than 0.1 mg protein was used per injection, none of the samples were critical in endotoxin levels (above 5-10 EU/kg of rabbit per injection) 37,38 .…”

Antiviral, Immunomodulatory and Antiproliferative Activities of Recombinant Soluble IFNAR2 without IFN-ß Mediation

“…The endotoxin levels of the recombinant sIFNAR2 purified were determined using the Endosafe ® -PTS™ system and the kinetic chromogenic "Limulus Amebocyte Lysate" (LAL) Test Cartridges with a sensitivity of 0.005 EU mL −1 (Charles River Laboratories, Wilmington, MA, USA). Endotoxin levels at the working dilutions used for all the experiments were less than 1 EU mL −1 , which is equivalent to a quantity of endotoxin lower than 0.1 ng mL −1 [20][21][22]. Supplementary Table S1 shows endotoxin levels of recombinant sIFNAR2.…”

“…Table S1: Endotoxin levels of the recombinant sIFNAR2 at working dilution determined using the Endosafe ® -PTS™ system and thekinetic chromogenic"Limulus Amebocyte Lysate" (LAL) Test Cartridges with a sensitivity of 0.005 EU mL −1 " (Charles River Laboratories). Endotoxin levels at the working dilutions used for all the experiments were less than 1 EU mL −1 , which is equivalent to a quantity of endotoxin lower than 0.1 ng mL −1 [20][21][22]". Funding: This research was funded by grants from the Instituto de Salud Carlos III and co-funded by European Regional Development Fund (ERDF) "A way to build Europe" research project PI13/00927 and Technological Development Project in health DTS/1800045 to B. Oliver-Martos.…”