In situ lysis of cells in lateral flow immunoassays

Patent No. 8,614,101

Issued: December 24, 2013
Filed: July 14, 2009
Term Extension: 742 days

Inventors: VanDine; Robert W. (Montoursville, PA), Babu; Uma Mahesh (Bradenton, FL), Sambursky; Robert P. (Bradenton, FL)
Assignee: Rapid Pathogen Screening, Inc. (Sarasota, FL)

Devices and methods incorporate lysis agents into a point-of-care testing device. The sample is loaded, and then the sample travels until it encounters a lysis agent. The lysis agent is preferably pre-loaded onto the collection device. In a preferred embodiment, the initially lysis agent is localized between the sample application zone and the conjugate zone. The lysis agent is preferably soluble or miscible in the sample transport liquid, and the lysis agent is solubilized and activated upon contact with the sample transport liquid. The sample transport liquid then contains both lysis agent in solution or suspension and sample components in suspension. Any lysis-susceptible components in a sample, then being exposed in suspension to the lysis agent, are themselves lysed in situ. The running buffer then carries the analyte, including any lysis-freed components, to the detection zone.

Reference to Related Applications

This application claims one or more inventions which were disclosed in Provisional Application No. 61/080,879, filed Jul. 15, 2008, entitled "LATERAL FLOW NUCLEIC ACID DETECTOR", Provisional Application No. 61/098,935, filed Sep. 22, 2008, entitled "IN SITU LYSIS OF CELLS IN LATERAL FLOW IMMUNOASSAYS", and Provisional Application No. 61/179,059, filed May 18, 2009, entitled "METHOD AND DEVICE FOR COMBINED DETECTION OF VIRAL AND BACTERIAL INFECTIONS". The benefit under 35 USC .sctn.119(e) of the U.S. provisional applications are hereby claimed, and the aforementioned applications are hereby incorporated herein by reference.

This application is also a continuation-in-part application of application Ser. No. 12/469,207, filed May 20, 2009, entitled "NANOPARTICLES IN DIAGNOSTIC TESTS", now abandoned, which claimed priority from Provisional Application No. 61/071,833, filed May 20, 2008, entitled "NANOPARTICLES IN DIAGNOSTIC TESTS" and application Ser. No. 12/481,631, filed Jun. 10, 2009, entitled "COMBINED VISUAL/FLUORESCENCE ANALYTE DETECTION TEST", now U.S. Pat. No. 8,470,608 which claimed priority from Provisional Application No. 61/060,258, filed Jun. 10, 2008, entitled "COMBINED VISUAL/FLUORESCENCE ANALYTE DETECTION TEST". The aforementioned applications are hereby incorporated herein by reference.

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