Clinical Innovations, LLC

Auric Enterprises, LLC

Bioassay Works

Glen Ford

William D Wallace

Leslie Kirkegaard

A method is taught for the accurate determination of the premature rupture of membranes (PROM), defined as spontaneous rupture of membranes before the onset of uterine contractions. More specifically, a lateral flow assay strip tests for at least two antigens to greatly limit or eliminate the possibility of false negatives. A built-in timer in the cassette holding the lateral flow assay further increases the accuracy of the test. A collection buffer vial with self-contained shipping and dropper caps and built-in stand is also taught.

Detection of amniotic fluid in vaginal secretions of pregnant women due to premature rupture of fetal membranes

A method is taught for the accurate determination of the premature rupture of membranes (PROM), defined as spontaneous rupture of membranes before the onset of uterine contractions. More specifically, a lateral flow assay strip tests for at least two antigens to greatly limit or eliminate the possibility of false negatives. A built in timer in the cassette holding the lateral flow assay further increases the accuracy of the test. A collection buffer vial with self-contained shipping and dropper caps and built in stand is also taught.

A chromatographic specific binding assay strip device, comprising: a non-permeable platform strip; a permeable membrane testing strip positioned on top of said non-permeable platform strip, with the testing strip comprising at least one capture reagent site containing a capture reagent for at least one specific analyte, a sample receiving pad positioned on top of and at a proximal end of the non-permeable platform strip, with the sample receiving pad having contact with a proximal end of said permeable membrane testing strip, a reservoir pad positioned on top of and at a distal end of said non-permeable membrane testing strip, with the reservoir pad having contact with a proximal end of said permeable membrane test strip; a supporting strip attached to and extending from the proximal end of said non-permeable platform strip; and a conjugate pad positioned on said supporting strip, said conjugate pad comprising a semi-permeable membrane containing a colorant conjugate. The semi-permeable membrane acts as a barrier between the conjugate pad and the sample receiving pad, regulating the flow through the semi-permeable membrane and overall flow of the assay. By dipping the conjugate pad into a sample solution, there will be increased binding between the analyte in the sample and the conjugate (preferably colloidal gold), thereby giving improved results on the lateral flow assay.

Immuno gold lateral flow assay

A chromatographic specific binding assay strip device, comprising: a non-permeable platform strip; a permeable membrane testing strip positioned on top of said non-permeable platform strip, with the testing strip comprising at least one capture reagent site containing a capture reagent for at least one specific analyte, a sample receiving pad positioned on top of and at a proximal end of the non-permeable platform strip, with the sample receiving pad having contact with a proximal end of said permeable membrane testing strip, a reservoir pad positioned on top of and at a distal end of said non-permeable membrane testing strip, with the reservoir pad having contact with a proximal end of said permeable membrane test strip; a supporting strip attached to and extending from the proximal end of said non-permeable platform strip; and a conjugate pad positioned on said supporting strip, said conjugate pad comprising a semi-permeable membrane containing a colorant conjugate. The semi-permeable membrane acts as a barrier between the conjugate pad and the sample receiving pad, regulating the flow through the semi-permeable membrane and overall flow of the assay by dipping the conjugate pad into a sample solution, there will be increased binding between the analyte in the sample and the conjugate (preferably colloidal gold), thereby giving improved results on the lateral flow assay.

A chromatographic lateral-flow assay system for rapid, high sensitivity method of detecting low levels of ligands in body fluids, with few false positives and few false negatives. The lateral-flow assay may have a membrane strip in ribbon form, which increases detection on the order of 2 to 10 fold over the conventional chromatographic specific binding assay techniques by placing a dried or lyophilized conjugate in colloidal spheres opposite side of the lateral flow membrane strip. A chromatographic specific binding assay strip device, comprising: a laminate strip having a first side and an opposite second side; a conjugate pad or membrane disposed on said first side of said laminate; a sample receiving pad or membrane strip and reservoir pad or membrane disposed on said second side of said laminate; and a detection pad or membrane strip disposed between the sample pad or membrane and the reservoir pad or membrane on said second side of said laminate. The assay system comprises a housing device, such as a test tube or cassettes to facilitate the mixing of a sample solution with the dried or lyophilized conjugate, and kits.

Growing community of inventors

Montgomery Village, MD, United States of America

Glen Ford