Rapid Pathogen Screening, Inc.

Quidel Corporation

Visus Therapeutics, Inc.

Robert P Sambursky

Robert W VanDine

Uma Mahesh Babu

Peter Condon

Franz Aberl

Marcus Scheibenzuber

Jose S Sambursky

Robert W Vandine

Ganga V Kanaujia

Thomas Orsini

Richard Rivas, Jr

A test strip with selective white blood cell (WBC) lysis for release of WBC contents and the capture and holding of red blood cells (RBC), allowing for fast clearance and result interpretation and more accurate results at early time points due to the lack of red color interference caused by background red heme color of lysing of RBCs. The removal of the red color interference enhances both visual and digital interpretation of test strips, such as test strips of an immunoassay test. The test strip enhances the detection of both intracellular proteins of WBCs and extracellular proteins of RBCs simultaneously such as MxA and CRP, MxA and PCT, MxA and HNL, and MxA and IL-6, MxA and myeloid cells (STREM-1), MxA and angiopoietin 2, MxA and vascular endothelial growth factor (VEGF) or its soluble vascular endothelial growth factor receptor-1 (sVEGFR1), MxA and heparin binding protein (HBP) or other combinations.

Selective white blood cell lysis for immunoassay systems

Devices and methods incorporate mucolytic agents into a point-of-care testing device. The sample is loaded, and then the sample travels until it encounters one or more lysis agents and/or mucolytic agents. The mucolytic agent is preferably pre-loaded onto the collection device. In a preferred embodiment, the mucolytic agent is localized between the sample application zone and the conjugate zone. In embodiments with a sample compressor, one or more mucolytic agents may be pre-loaded and dried on the sample compressor, the sample collector, in various locations on the test strip, or in the running buffer.

Methods and devices for using mucolytic agents including N-acetyl cysteine (NAC)

Diagnostic devices test markers for viral infection and markers for bacterial infection to effectively assist in the rapid differentiation of viral and bacterial infections, to differentiate between colonization and active infection, and to better diagnose microbiologically unconfirmed patients. In other embodiments, detecting a presence of MxA in combination with either the bacterial biomarker C-reactive protein or the bacterial biomarker procalcitonin increases the specificity of the bacterial biomarker with a concurrent improvement in sensitivity.

Methods and devices for accurate diagnosis of infections

Histatins may be used for corneal wound healing and as a treatment for ocular surface disease in humans and other animals. For example, histatins could be included in eye drops, eye gels, ointment, glue, or embedded in (polymer) contact lenses.

Histatin for corneal wound healing and ocular surface disease

A lateral flow assay is capable of detecting and differentiating viral and bacterial infections. A combined point of care diagnostic device tests markers for viral infection and markers for bacterial infection, to effectively assist in the rapid differentiation of viral and bacterial infections. In some preferred embodiments, bimodal methods and devices determine if an infection is bacterial and/or viral. A dual use two strip sample analysis device includes a first lateral flow chromatographic test strip to detect MxA and a low level of C-reactive protein and a second lateral flow chromatographic test strip to detect high levels of C-reactive protein. In some preferred embodiments, the sample is a fingerstick blood sample.

Method and device for combined detection of viral and bacterial infections

More particularly, the present invention relates to a method for the detection of a target, e.g. pathogen in a human body fluid wherein a body fluid sample is collected with a swab member.

Device for the detection of an analyte in a fluid sample

A sample compressor applies pressure to a sample collector and a sample application zone of a test strip to transfer a sample from the sample collector and a binding partner of an analyte to the sample application zone in a lateral flow device. At least one of the binding partners of the analyte is not located on the test strip prior to use of the lateral flow device. The test strip may be a universal test strip with no molecule that specifically binds the analyte is located on the test strip. The sample compressor may be a universal sample compressor also with no molecule that specifically binds the analyte on the sample compressor. The lateral flow device may also include one or more enhancement elements, where the enhancement elements bind to the analyte sandwich to increase a detection signal in the test zone.

Multiplanar lateral flow assay with sample compressor

A lateral flow assay detects and differentiates between viral and bacterial infections. A combined point of care diagnostic device tests markers for viral infection and markers for bacterial infection, to effectively assist in the rapid differentiation of viral and bacterial infections. In one preferred embodiment, the bacterial marker is CRP. In another preferred embodiment, the viral marker is MxA. In some embodiments, it is unnecessary to lyse the cells in the sample prior to applying it to the device.

Methods and devices for using mucolytic agents including N-Acetyl Cysteine (NAC)

The present invention includes methods and devices for preventing interfering substances from affecting the accuracy of a lateral flow immunoassay. In preferred embodiments, a test strip includes a capturing zone that includes at least one mobile capturing reagent that separates at least one interfering substance from the analyte. The capturing zone is preferably located upstream of the sample application zone. In some embodiments, the reagent/conjugate zone is also located upstream of the sample application zone. The capturing zone may be located upstream, downstream, or overlapping with the reagent/conjugate zone in these embodiments. In other preferred embodiments, one or more mobile capturing reagents are included in the elution medium/running buffer. In yet other embodiments, the capturing reagent is incorporated into a sample collection device of a sample collection system, preferably separate from the chromatographic test strip. A lysis zone is also included in some preferred embodiments.

Method to increase specificity and/or accuracy of lateral flow immunoassays

Methods and devices for detecting a target enzyme include an anchored or trapped peptide complex. The peptide complex includes an anchor particle immobilized on a sample analysis device or trapped in a reaction receptacle including a filter, a peptide, with at least one enzyme cleavage site for a target enzyme, bound to the anchor particle, at least one detectable label, and at least one first tag bound to the peptide on a side of the enzyme cleavage site opposite the anchor particle. When the target enzyme is present in the sample, the enzyme cleaves the peptide at the enzyme cleavage site, permitting the cleaved peptide to reach the test zone of a sample analysis device such that the first tag binds to the immobilized second tag and a signal is detected at the test zone.

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Bradenton, FL, United States of America

Robert P Sambursky