Methods for detecting an endotoxin with a lysate reagent

Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving viable micro-organism

Reexamination Certificate

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C435S024000

Reexamination Certificate

active

07833747

ABSTRACT:
An object of the present invention is to provide a method capable of detecting and quantifying endotoxin in a sample in which endotoxin derived from gram-negative bacteria cannot be accurately detected or quantified by the method described in Commentary of the Japanese Pharmacopoeia Fourteenth Edition, Hirokawa Publishing Co. 2001 B-63. It has been found that the above object can be achieved by performing an endotoxin test using a lysate reagent in which the lysate reagent is added into a sample in the presence of albumin and/or globulin.

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Asakawa, Sadao et al., “Application of the Limulus Test for Practical Quality Control on Endotoxin Content in Commercial Human Serum Albumin (HSA) Products. In Comparsion With the Rabbit Pyrogen Test”, vol. 114, No. 11, pp. 888 to 893, 1994.
A. M. Cundell, “Use of the Limulus Amebocyte Lysate Endotoxin Assay in Plasma Fractionation.”, Progr. Clin. Biol. Res., 1982, vol. 93, pp. 269-280.
Japanese Phamacopoeia Fourteenth Edition, Hirokawa Publishing Co. 2001 B-63 (English Translation) pp. 20-23 w
otes.

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