Abstract: This invention pertains to devices, compositions and methods that can be used for the rapid determination of microorganisms, cells and other analytes of interest (e.g. a nucleic acid target) as well as associated properties of said microorganisms, cells and analytes. For example, said devices, compositions and/or methods can be applied to the determination of a trait of a microorganism present in a sample. Said devices, compositions and methods utilize matrix-forming prolonged-dissolution hydrophilic polymer to encapsulate hybridization probes and optionally other assay reagents within two or more reagent zones and/or matrix zones disposed on the surface of a substrate. Each reagent zone and/or matrix zone can be designed as a separate assay. Thus, a plurality of assays can be performed on a single substrate. In some embodiments, devices can be supplied in a form ready for a customer to rapidly perform one or a plurality of assays.

Abstract: The present invention features methods for selective lysis of endogenous cells in a biological sample. In preferred embodiments, the methods of the invention comprise contacting the biological sample with lysis solution, and subjecting the mixture to ultrasound, thereby selectively lysing the endogenous cells in the biological sample. The invention also features a lysis solution comprising Saponin and Proteinase.

Abstract: The present invention features methods for selective lysis of endogenous cells in a biological sample. In preferred embodiments, the methods of the invention comprise contacting the biological sample with lysis solution, and subjecting the mixture to ultrasound, thereby selectively lysing the endogenous cells in the biological sample. The invention also features a lysis solution comprising Saponin and Proteinase.

Abstract: The present invention relates to peptide nucleic acid (PNA) probes, PNA probe sets and methods for the analysis of Gram positive and Gram negative organisms optionally present in a sample. The invention further relates to diagnostic kits comprising such PNA probes.

Abstract: Methods of determining whether a target bacteria is susceptible to an antimicrobial compound are provided. In some embodiments the methods comprise providing a sample comprising the target bacteria; maintaining the sample in the presence of an antimicrobial compound to provide an antimicrobial compound-exposed target bacterial sample; exposing the antimicrobial compound-exposed target bacterial sample to a cell-wall disruption condition; and determining the level of lysis and/or the level of remaining intact cells present in the antimicrobial compound-exposed target bacterial sample whether the cell-wall disruption condition lyses target bacterial cells present in the antimicrobial compound-exposed target bacterial sample; wherein the method is performed such that the level of lysis and/or remaining intact cells is determined without determining lysis or non-lysis on a cell-by-cell basis. In some embodiments target bacteria are not immobilized during the exposure to cell-wall disruption conditions.

Abstract: This application pertains to methods for the whole-cell analysis of gram-positive bacteria. The methods are capable of making a determination of whether or not a sample (e.g., a clinical sample) comprises one or more select gram-positive bacteria as well as, for example, whether or not none, some or all of said select gram-positive bacteria in said sample, or possibly other bacteria in said sample, possess a select trait or traits of interest. In some embodiments, the methods can be used to determine methicillin-resistant (the select trait) staphylococcus aureus (the select gram-positive bacteria), coagulase-negative staphylococci (another select gram-positive bacteria) and/or methicillin-sensitive staphylococcus aureus (MSSA) in said sample. The whole-cell analysis can be performed, for example, by in-situ hybridization (ISH), fluorescence in-situ hybridization (FISH), immunocytochemistry (ICC), or any combination of two or more of the foregoing.

Abstract: This invention pertains to identifying one or more hybridization probes sequestered within (or optionally released from the intact) cells or microorganisms by mass spectrometry to thereby determine a trait of the cells or microorganisms and/or to identify the cells or microorganisms themselves. The cells or microorganisms can come from a subject and the information obtained from the mass spectrometry analysis may, if clinically relevant, optionally be used to diagnose and/or treat the subject.

Abstract: Provided herein are methods, kits and compositions to classify fungi. Methods are provided for classification of fungi according to established phenotypes, for example, antimicrobial susceptibility profiles. More specifically, the invention provides methods for the use of PNA probes in diagnostic applications, which will aid in the direction of appropriate therapy against fungi.

Abstract: Provided herein are methods, kits and compositions to classify fungi. Methods are provided for classification of fungi according to established phenotypes, for example, antimicrobial susceptibility profiles. More specifically, the invention provides methods for the use of PNA probes in diagnostic applications, which will aid in the direction of appropriate therapy against fungi.

Abstract: This invention pertains to devices, compositions and methods that can be used for the rapid determination of microorganisms, cells and other analytes of interest (e.g. a nucleic acid target) as well as associated properties of said microorganisms, cells and analytes. For example, said devices, compositions and/or methods can be applied to the determination of a trait of a microorganism present in a sample. Said devices, compositions and methods utilize matrix-forming prolonged-dissolution hydrophilic polymer to encapsulate hybridization probes and optionally other assay reagents within two or more reagent zones and/or matrix zones disposed on the surface of a substrate. Each reagent zone and/or matrix zone can be designed as a separate assay. Thus, a plurality of assays can be performed on a single substrate. In some embodiments, devices can be supplied in a form ready for a customer to rapidly perform one or a plurality of assays.

Abstract: A system and method for guided laboratory data collection, analysis, and reporting is provided. The system provides a software module with an interactive user interface for icon-based entry of test results by an operator. The system includes a computer system in communication with one or more laboratory information systems and/or one or more hospital information systems to assist in timely laboratory testing and reporting. Further, the system could also provide laboratory testing results directly to medical doctors and/or other medical professionals.

Abstract: The present invention relates to peptide nucleic acid (PNA) probes, PNA probe sets and methods for the analysis of certain Staphylococcus species optionally present in a sample. The invention further relates to diagnostic kits comprising such PNA probes or PNA probe sets.

Abstract: Disclosed is a PNA probe that includes a nucleobase sequence suitable for the detection, identification and/or quantitation of Pseudomonas (sensu stricto). In one embodiment, the PNA probe is complementary to a target sequence of 23S rRNA or rDNA from all species of the genus Pseudomonas. The invention has a wide range of important uses including detecting Pseudomonas in a sample of interest.

Abstract: The present invention relates to peptide nucleic acid (PNA) probes, PNA probe sets and methods for the analysis of certain Staphylococcus species optionally present in a sample. The invention further relates to diagnostic kits comprising such PNA probes or PNA probe sets.

Abstract: The present invention relates to peptide nucleic acid (PNA) probes, PNA probe sets and methods for the analysis of certain Staphylococcus species optionally present in a sample. The invention further relates to diagnostic kits comprising such PNA probes or PNA probe sets.

Abstract: This invention relates to the use of genetic probes for detection of the presence of the SCCmec cassette in Staphylococcus aureus. In one aspect, the invention allows specific detection and identification of methicillin-resistant S. aureus (MRSA) in a clinical sample without interference from the presence of other non-S. aureus methicillin-resistant staphylococci. In another aspect, the invention allows specific detection and identification of methicillin-resistant coagulase negative staphylococci (MRCNS) originating from a clinical sample without interference from the presence of methicillin-resistant S. aureus.

Abstract: The present invention relates to peptide nucleic acid (PNA) probes, PNA probe sets and methods for the analysis of certain Staphylococcus species optionally present in a sample. The invention further relates to diagnostic kits comprising such PNA probes or PNA probe sets.

Abstract: This application pertains to methods for the whole-cell analysis of gram-positive bacteria. The methods are capable of making a determination of whether or not a sample (e.g. a clinical sample) comprises one or more select gram-positive bacteria as well as, for example, whether or not none, some or all of said select gram-positive bacteria in said sample, or possibly other bacteria in said sample, possess a select trait or traits of interest. In some embodiments, the methods can be used to determine methicillin-resistant (the select trait) staphylococcus aureus (the select gram-positive bacteria), coagulase-negative staphylococci (another select gram-positive bacteria) and/or methicillin-sensitive staphylococcus aureus (MSSA) in said sample. The whole-cell analysis can be performed, for example, by in-situ hybridization (ISH), fluorescence in-situ hybridization (FISH), immunocytochemistry (ICC), or any combination of two or more of the foregoing.

Abstract: Disclosed is a PNA probe that includes a nucleobase sequence suitable for the detection, identification and/or quantitation of Pseudomonas (sensu stricto). In one embodiment, the PNA probe is complementary to a target sequence of 23S rRNA or rDNA from all species of the genus Pseudomonas. The invention has a wide range of important uses including detecting Pseudomonas in a sample of interest.

Abstract: The instant invention provides PNA probes for detection, identification and/or quantitation of microorganisms, e.g., Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Streptococcus agalactiae, fungi, and Acinetobacter species. The invention further provides methods of using the PNA probes of the invention and kits containing the PNA probes of the invention.