LECTIN-BASED ASSAY FOR DETECTING MICROBIAL CONTAMINATION

Abstract

An analytical method to detect microbial contaminants in an oily liquid, comprising: a) preparing an aqueous liquid from the oily liquid, thereby obtaining glycan-containing microbial material originating from any microbial contaminants comprised in the oily liquid; b) determining the presence of glycans in the aqueous liquid using a lectin-based lateral-flow assay (LFA) that employs mannose-binding protein (MBP) as capture agent of a test region of a lateral flow membrane and as capture agent bound to flowable, identifiable reporter nanoparticles, using a capture reaction buffer (CRB) which comprises 100 to 500 mM free calcium ions, a detergent, a buffer agent and a pH ranging between 6.5 and 9.0, thereby allowing identification of an MBP sandwiched capture product at the test region, which indicates microbial contamination; and a test kit for use in the method, which comprises: a) a lectin-based lateral-flow assay device, which employs mannose-binding protein (MBP) as capture agent that is bound to flowable, identifiable reporter nanoparticles at a reaction zone of a lateral flow membrane; and b) a running buffer which comprises a detergent, a buffer agent and a pH ranging between 6.5 and 9.0, which running buffer comprises 100 to 500 mM free calcium ions and sets an amount of 100 to 500 mM free calcium ions at the reaction zone, wherein the reaction zone comprises the MBP bound to the reporter nanoparticles at a conjugate zone, and a test region comprising a test line where immobilized MBP is used as a capture agent.

Inventors

HIMMLER, GOTTFRIED
WOLOSZCZUK, WOLFGANG
MARENZI, Luca
TESARZ, Manfred

Assignees

The Antibody Lab GmbH

Dates

Publication Date: 20260506
Application Date: 20241218