Abstract: Disclosed is are methods for identifying a nucleic acid in a sample. In one example, the method includes: (a) contacting the nucleic acid in the sample with an oligonucleotide that is specific for the nucleic acid in the sample and that is labeled with at least a first fluorescent dye; (b) contacting the nucleic acid in the sample with a second fluorescent dye that is different from the first fluorescent dye, such that the second fluorescent dye interacts with the nucleic acid; (c) amplifying the nucleic acid if present in the sample; and (d) detecting the nucleic acid if present in the sample by observing fluorescence from the first fluorescent dye after the oligonucleotide hybridizes to the amplified nucleic acid and determining the melting temperature of the amplified nucleic acid by measuring the fluorescence of the second fluorescent dye. The second fluorescent dye may include a fluorescent intercalating agent.

Abstract: A container system and a method for transporting hazardous materials is disclosed. One embodiment of the container system includes a soft-sided outer shell and an inner frame. The outer shell is at least partially collapsible when unsupported. The outer shell may include a plurality of vertical walls integrally formed with a bottom and an open top. A lid may be adapted to be selectively secured to the vertical walls to close the outer shell. A fastener, such as a zipper, may be provided to secure the lid to the vertical walls. The inner frame has rigid walls and is adapted to support the outer shell when the inner frame is inserted inside the outer shell. The inner frame is at least partially collapsible. One embodiment of the method includes providing a soft-sided container that is at least partially collapsible when unsupported. Hazardous material is positioned into the container.

Abstract: A device and method for detecting the presence of hemoglobin in a biological sample, more particularly, the presence of blood in a fecal sample as an indicator of upper or lower gastrointestinal tract bleeding.

Abstract: Provided are methods for determining the presence or amount of testosterone in a test sample, comprising ionizing all or a portion of the testosterone present in the sample to produce one or more testosterone ions that are detectable in a mass spectrometer. All or a portion of the testosterone present in the sample is ionized to produce one or more testosterone ions, which may be isolated and fragmented to produce precursor ions. A separately detectable internal testosterone standard can be provided in the sample. In a preferred embodiment, the reference is 2,2,4,6,6-d5 testosterone.

Abstract: Provided are methods of detecting the presence or amount of a vitamin D metabolite in a sample using mass spectrometry. The methods generally comprise ionizing a vitamin D metabolite in a sample and detecting the amount of the ion to determine the presence or amount of the vitamin D metabolite in the sample. Also provided are methods to detect the presence or amount of two or more vitamin D metabolites in a single assay.

Abstract: A method for detecting amino acids in body fluids is described. The method includes derivatizing the body fluid amino acids (e.g. plasma amino acids), separating the derivatized amino acids by liquid chromatography followed by and subjecting the identification by mass spectrometry. The identity of each amino acid from the body fluid is determined by comparing to a set of structurally similar amino acid standards, which preferably are added to the body fluid sample as internal standards. Use of the method of diagnose an individual with a metabolic disorder is also provided.

Abstract: The present invention provides a simple high-throughput assay for detecting bcr/abl translocations. The method includes qualitative PCR methods for identifying the particular amplified translocation (e1a2 or b2a3/b3a2) and real time PCR for quantifying an amount of bcr/abl transcript (e1a2, b2a3 and b3a2). Quantitative measurement of bcr/abl transcript in accordance with the methods of the invention is useful for monitoring response to therapy.

Abstract: The present invention relates to the diagnosis of hematopoietic disorders and to determining the prognosis of patients affected by such disorders. The methods generally comprise determining a level of myeloperoxidase in a body fluid sample from the individual and using the level as a factor for diagnosing the disorder in the mammal or as a factor for determining the prognosis of a patient diagnosed with such a disorder. Myelodysplastic syndrome, acute myeloid leukemia and chronic myeloid leukemia are exemplary disorders. Also provided are method of cancer therapy involving reducing the level of myeloperoxidase in the body fluid of the individual.

Abstract: A reagent cartridge for a assay device comprises a frame and at least one reagent container. A reagent cartridge frame comprises a plurality of sidewalls, one of the sidewalls includes at least one detent to engage with a flange on a reagent container, and another sidewall includes at least one notch to engage with a rib on the reagent container. The reagent cartridge frame permits various numbers of reagent containers to be placed in the frame at any position and in any order depending on the assay being performed. The reagent cartridge may also be used with as few as one reagent container.

Abstract: Methods are described for the processing of biological samples for direct use in nucleic acid amplification without extracting or isolating the nucleic acids from the sample. In preferred embodiments, the processed sample provides the nucleic acid template in PCR-based assays.

Abstract: Disclosed are methods for amplifying and sequencing target segments of nucleotides. In the method, nucleic acids are amplified using at least two oligonucleotide primers, wherein at least one of the primers contains a complimentary region that hybridizes adjacent to the target segment of nucleotides and an extender region that includes a primer hybridization sequence. Also included are methods of amplification with an extender region includes a sequence encoding a promoter for an RNA polymerase and optionally sequences for translation. The latter amplified products may be used for transcription of a RNA including subsequent translation of the RNA to generate a protein product.

Abstract: The present invention relates to the diagnosis of hematopoietic disorders and to determining the prognosis of patients affected by such disorders. The methods generally comprise determining a level of myeloperoxidase in a body fluid sample from the individual and using the level as a factor for diagnosing the disorder in the mammal or as a factor for determining the prognosis of a patient diagnosed with such a disorder. Myelodysplastic syndrome, acute myeloid leukemia and chronic myeloid leukemia are exemplary disorders. Also provided are method of cancer therapy involving reducing the level of myeloperoxidase in the body fluid of the individual.

Abstract: Disclosed is a method for detecting human retroviral nucleic acids such as human immunodeficiency virus type I (HIV-1) nucleic acid, human T-cell leukemia virus type I (HTLV-I) nucleic acid, and human T-cell leukemia virus type II (HTLV-II) nucleic acid in a sample. In the method, the sample is treated with reverse transcriptase to generate cDNA, and the cDNA is subsequently analyzed to detect HIV-1, HTLV-I, and HTLV-II. The method may include performing PCR and the method may utilize specific primers. In addition, the method may utilize HTLV linkers that facilitate PCR amplification and sequencing. The cDNA may be treated with restriction enzymes before or after PCR amplification to facilitate sequencing and detection of HIV-1, HTLV-I, or HTLV-II nucleic acid.

Abstract: A method is provided for receiving an order for a laboratory test of a biological specimen for a patient utilizing a computer network including a client computer and a central computer. The method includes facilitating a connection between the client computer and the central computer. A laboratory test request is received at the central computer from the client computer. Patient, billing, and diagnosis information corresponding to the requested laboratory test is also received at the central computer from the client computer. Information is transmitted from the central computer to the client computer for generating a test requisition and a label for use with the biological specimen.

Abstract: Methods are described for the processing of biological samples for direct use in nucleic acid amplification without extracting or isolating the nucleic acids from the sample. In preferred embodiments, the processed sample provides the nucleic acid template in PCR-based assays.

Abstract: The present invention provides methods for determining the genotype of a selected gene present in at least two alleles in a sample. The methods involve amplifying DNA from the sample with a first pair of flanking primers that hybridize to nucleic acid sequences flanking a variant-specific gene sequence, the presence of which indicates the presence of a first gene variant, and the absence of which indicates the presence of a second gene variant. The DNA is also amplified with a third primer that specifically binds to the variant-specific sequence and together with one of the flanking primers forms a second pair of primers. Detection of one or more nucleic acid products of the amplification reaction is indicative of the genotype present in the sample.

Abstract: Provided are methods of determining differences between nucleic acids in a test sample and a reference sample. In certain embodiments the methods are used for detecting and mapping chromosomal or genetic abnormalities associated with various diseases or with predisposition to various diseases, or to detecting the phenomena of large scale copy number variants. In particular, provided are advanced methods of performing array-based comparative hybridization that allow reproducibility between samples and enhanced sensitivity by using the same detectable label for both test sample and reference sample nucleic acids. Invention methods are useful for the detection or diagnosis of particular disease conditions such as cancer, and detecting predisposition to cancer based on detection of chromosomal or genetic abnormalities and gene expression level. Invention methods are also useful for the detection or diagnosis of hereditary genetic disorders or predisposition thereto, especially in prenatal samples.

Abstract: Methods for detecting invasive trophoblast antigen (ITA) in biological samples comprise screening the samples for ITA using antibodies that bind to the ITA. The methods are useful to detect pregnancy, trophoblastic diseases, and Down's syndrome in fetuses of pregnant women. Some methods include screening the samples with a plurality of capture antibodies that specifically bind ITA. Chemiluminescent immunoassays are disclosed. The methods may be practiced with the diagnostic kits of the invention.

Abstract: A system and method of diagnosing diseases from biological data is disclosed. A system for automated disease diagnostics prediction can be generated using a database of clinical test data. The diagnostics prediction can also be used to develop screening tests to screen for one or more inapparent diseases. The prediction method can be implemented with Bayesian probability estimation techniques. The system and method permit clinical test data to be analyzed and mined for improved disease diagnosis.

Abstract: Provided are methods for determining the presence or amount of testosterone in a test sample, comprising ionizing all or a portion of the testosterone present in the sample to produce one or more testosterone ions that are detectable in a mass spectrometer. All or a portion of the testosterone present in the sample is ionized to produce one or more testosterone ions, which may be isolated and fragmented to produce precursor ions. A separately detectable internal testosterone standard can be provided in the sample. In a preferred embodiment, the reference is 2,2,4,6,6-d5 testosterone.