Abstract: An assay kit of reagents including a nucleic acid capable of acting as substrate for polymerase microorganism activity useful in a method of detecting polymerase activity as an indicator of the presence of a micro-organism in a sample are disclosed. The disclosed embodiments also relate to reagents for use in such methods, and to test kits comprising such reagents for carrying out the methods.

Abstract: Methods for detecting microorganisms, in particular detection of bacteria and methods for measuring enzyme activity, such as Deoxyribonucleic acid (DNA) polymerase activity are disclosed. The aforesaid methods include, but are not limited to such methods performed on microbial crude lysates, useful for determining microbial enzyme activities, which can be linked to amplification signal generators such as real-time Polymerase Chain Reaction (PCR) techniques, thereby enabling determination of microbial pathogens in samples such as unpurified blood and other body fluids. Moreover, the disclosed embodiments also relate to reagents for use in such methods, and to test kits comprising such reagents for carrying out the methods.

Abstract: Methods for detecting microorganisms, in particular detection of bacteria and methods for measuring enzyme activity, such as Deoxyribonucleic acid (DNA) polymerase activity are disclosed. The aforesaid methods include, but are not limited to such methods performed on microbial crude lysates, useful for determining microbial enzyme activities, which can be linked to amplification signal generators such as real-time Polymerase Chain Reaction (PCR) techniques, thereby enabling determination of microbial pathogens in samples such as unpurified blood and other body fluids. Moreover, the disclosed embodiments also relate to reagents for use in such methods, and to test kits comprising such reagents for carrying out the methods.

Abstract: An assay kit of reagents including a nucleic acid capable of acting as substrate for polymerase microorganism activity useful in a method of detecting polymerase activity as an indicator of the presence of a micro-organism in a sample are disclosed. The disclosed embodiments also relate to reagents for use in such methods, and to test kits comprising such reagents for carrying out the methods.

Abstract: A method for performing a diagnostic assay for the detection of the presence or amount of a microorganism within a sample matrix containing active DNA polymerase, is disclosed. The method utilizes the measurement of DNA polymerase extension activity, wherein the assay comprises the steps of incubating DNA polymerase in the sample matrix with a selected suitable substrate, and performing PCR cycling and detection via the use of a selected suitable nucleic acid probe, thereby to detect endogenous DNA polymerase extension activity in the sample matrix as an indication of the presence or amount of said microorganism.

Abstract: A novel, highly sensitive, quantitative and rapid DPE-PCR assay is disclosed that can be used to enumerate prokaryotic cells when presenting a purified or selected cell type and that has the capability to reproducibly measure DNA polymerase extension activity from less than 10 cfu of bacteria via coupling to bead lysis. Also disclosed is the potential for the DPE-PCR assay of the invention to universally detect microbes by testing a panel of microorganisms comprised of gram-negative bacteria, gram-positive bacteria and Candida species. Furthermore, it is disclosed that the DPE-PCR assay of the invention can be used to assess bacterial cell viability, provided via the reproducibly strong correlation between DNA polymerase extension activity and proliferation as indicated by the presence of cfu. It is believed that the disclosed assay of the invention can be a useful quantitative tool for a wide range of testing applications within pharmaceutical, environmental, food and clinical settings.

Abstract: A method for performing a diagnostic assay for the detection of the presence or amount of a microorganism within a sample matrix containing active DNA polymerase, is disclosed. The method utilizes the measurement of DNA polymerase extension activity, wherein the assay comprises the steps of incubating DNA polymerase in the sample matrix with a selected suitable substrate, and performing PCR cycling and detection via the use of a selected suitable nucleic acid probe, thereby to detect endogenous DNA polymerase extension activity in the sample matrix as an indication of the presence or amount of said microorganism.

Abstract: The present invention relates to novel methods, and kits, for selectively excluding dead cells from a mixture containing live and dead cells, such as microbe cells in clinical samples, blood products, medical/biotechnology products and food products where subsequent interrogation of the selected live cells are an indicator of the presence of microbe viability. In particular, the invention relates to improved methods for performing direct nucleic acid amplification techniques such as Polymerase Chain Reaction (PCR) and isothermal techniques in blood and other body fluids, for correlation with microbe cell viability from Bacteremia and Fungemia samples. The improved methods provided by the invention are particularly advantageous for the diagnosis of septicemia and to determine pathological conditions in all other normally sterile body fluids.

Abstract: The present invention relates generally to the field of detection of microorganisms, in particular detection of bacteria, to methods for measuring enzyme activity, such as DNA polymerase activity, and particularly relates to such methods performed on microbial crude lysates, useful for determining microbial enzyme activities which can be linked to amplification signal generators such as real-time Polymerase Chain Reaction (PCR) techniques, thereby enabling determination of microbial pathogens in samples such as unpurified blood and other body fluids. This invention also relates to reagents for use in such methods, and to test kits comprising such reagents for carrying out the methods.

Abstract: The methods and reagents described in this invention are used to analyze circulating tumor cells, clusters, fragments, and debris. Analysis is performed with a number of platforms, including flow cytometry and the CELLSPOTTER® fluorescent microscopy imaging system. Analyzing damaged cells has shown to be important. However, there are two sources of damage: in vivo and in vitro. Damage in vivo occurs by apoptosis, necrosis, or immune response. Damage in vitro occurs during sample acquisition, handling, transport, processing, or analysis. It is therefore desirable to confine, reduce, eliminate, or at least qualify in vitro damage to prevent it from interfering in analysis. Described herein are methods to diagnose, monitor, and screen disease based on circulating rare cells, including malignancy as determined by CTC, clusters, fragments, and debris. Also provided are kits for assaying biological specimens using these methods.

Abstract: The present invention provides methods, compositions and diagnostic kits for the detection of Staphylococcus Aureus (SA) and antibiotic resistant forms and variants thereof, such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Staphylococcus aureus (VRSA), mupirocin-resistant Staphylococcus aureus (mupSA), and the like, in a sample population. The invention preferably involves the improvements of bacterial sampling by means of SA enrichment, followed by SA cell disruption and amplification procedures incorporating the use of multiplex assays for SA specific genes, such as mecA and coagulase negative Staphylococci (CONS) specific genes such as tufA, for SA identification and identification of its known species. This provides means for controlling for the thirty or more known CONS species in assessing SA samples, especially those CONS species that may carry antibiotic resistance genes, such as SCCmec.

Abstract: Methods and compositions, including diagnostic kits, for the detection of Staphylococcus Aureus (SA) and clinically important antibiotic resistant forms thereof, such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Staphylococcus aureus (VRSA), mupirocin-resistant Staphylococcus aureus (mupSA), and the like, from individuals in a sample population are disclosed Also disclosed are cost effective methods and kits for bacterial sampling and analysis via inherent and expeditious SA cell disruption methods followed by Direct PCR, circumventing the need, expense and contamination ?sks associated with DNA isolation methods These improved methods in conjunction with SA prevalence analysis are applied so as to eliminate the approximately 70% of samples in the human population which do not carry SA (SA negative), followed by a second more costly test for antibiotic resistant forms thereof, such as amplification to confirm for presence of MRSA or other target disease

Abstract: The methods and reagents described in this invention are used to analyze circulating tumor cells, clusters, fragments, and debris. Analysis is performed with a number of platforms, including flow cytometry and the CellSpotter® fluorescent microscopy imaging system. Analyzing damaged cells has shown to be important. However, there are two sources of damage: in vivo and in vitro. Damage in vivo occurs by apoptosis, necrosis, or immune response. Damage in vitro occurs during sample acquisition, handling, transport, processing, or analysis. It is therefore desirable to confine, reduce, eliminate, or at least qualify in vitro damage to prevent it from interfering in analysis. Described herein are methods to diagnose, monitor, and screen disease based on circulating rare cells, including malignancy as determined by CTC, clusters, fragments, and debris. Also provided are kits for assaying biological specimens using these methods.

Abstract: The methods and reagents described in this invention are used to analyze circulating tumor cells, clusters, fragments, and debris. Analysis is performed with a number of platforms, including flow cytometry and the CellSpotter® fluorescent microscopy imaging system. Analyzing damaged cells has shown to be important. However, there are two sources of damage: in vivo and in vitro. Damage in vivo occurs by apoptosis, necrosis, or immune response. Damage in vitro occurs during sample acquisition, handling, transport, processing, or analysis. It is therefore desirable to confine, reduce, eliminate, or at least qualify in vitro damage to prevent it from interfering in analysis. Described herein are methods to diagnose, monitor, and screen disease based on circulating rare cells, including malignancy as determined by CTC, clusters, fragments, and debris. Also provided are kits for assaying biological specimens using these methods.

Abstract: A method for assessing tumor progression is described by assessing AGR2 and/or TFF3 expression in a biological sample after induction of a physiological stress, such as hypoxia or serum deprivation in an enriched sample. Assessing the role of these indicators and their expression levels in an enriched CTC sample provides diagnostic and prognositic information on a patient. This method is also useful as a pharmatool in drug discovery.

Abstract: Methods and compositions are provided for detecting circulating tumor cells and assessing said cells for alterations in tumor-diathesis associated molecules.