Rapid Pathogen Screening, Inc.

The Penn State Research Foundation

Quidel Corporation

Med-ag Industries, Inc.

Visus Therapeutics, Inc.

Robert W VanDine

Robert P Sambursky

Uma Mahesh Babu

Marcus Scheibenzuber

Jose S Sambursky

Peter Condon

Franz Aberl

Ganga V Kanaujia

Thomas Orsini

Louis M Bassler

John V Vargo

Troy L Ott

Richard Rivas, Jr

Robert F Sambursky

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

A 'one-step', single-handed device for obtaining small, precise volumes of fluid from animals is able to quickly and easily draw a fluid sample. The device comprises an extraction component and a collection component that are coupled together and disposed along a grip handle. The user manipulates the device so as to initiate the extraction of the fluid, and then collect the fluid in a component that can quickly and easily be removed from the grip handle&#x2014;allowing the handle to be re-loaded and used again and again. The extraction component may comprise a hypodermic needle and the collection component may comprise a pre-calibrated pipette, where the pipette is positioned directly behind the needle and will thus draw the extracted fluid into a pre-sized chamber within the pipette.

Device for obtaining small, precise volumes of fluid from animals

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.

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.

Enzymatic cleavage based lateral flow assays

Assays and methods including mobile tagged single stranded nucleic acid reagents pre-loaded on an analysis device, which are preferably tagged, but not labeled and are complementary to a strand (preferably the anti-sense strand in double stranded DNA targets) of the target nucleic acid. The assay also includes a running buffer that includes a dye or other detectable label that nonspecifically binds only to double stranded nucleic acids. In addition, the analysis device includes a detection zone including one or more test zones that have an immobilized tag that binds to the tag on the mobile nucleic acid reagent.

Lateral flow assays

A lateral flow device may include one or more enhancement elements, where the enhancement elements bind to the analyte sandwich to increase a detection signal in the test zone. In preferred embodiments, some or all of the enhancement elements are encapsulated.

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Montoursville, PA, United States of America

Robert W VanDine