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The Lyra™ Direct HSV 1 + 2/VZV Assay is an in vitro multiplex Real-Time PCR test for qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1. herpes simplex virus 2 and/or varicella-zoster infection. The Lyra™ Direct HSV 1 + 2/VZV Assay is intended to aid in the diagnosis of herpes simplex virus 1, herpes simplex virus 2 and varicella-zoster virus active cutaneous or mucocutaneous infections. Negative results do not preclude herpes simplex virus 1, herpes simplex virus 2 and varicella-zoster virus infections and should not be used as the sole basis for diagnosis, treatment or other management decisions. The Lyra™ Direct HSV 1 + 2/VZV Assay is not intended for use with cerebrospinal fluid or to aid in the diagnosis of HSV or VZV infections of the central nervous system (CNS). The Lyra™ Direct HSV 1 + 2/VZV Assay is not intended for use in prenatal screening. The device is not intended for point-of-care use.

The Lyra™ Direct HSV 1 + 2/VZV Assay detects viral nucleic acids from a patient sample. A multiplex Real-Time PCR reaction is carried out under optimized conditions in a single tube or well generating amplicons for HSV-1, HSV-2, VZV, and the Process Control (PRC). Identification of amplicons for HSV-1, HSV-2, VZV, and the PRC occurs by the use of target-specific primers and fluorescent-labeled probes that hybridize to conserved regions in the genomes of HSV-1, HSV-2, and VZV and to the PRC, respectively.

The Thyretain ™ TSI Reporter BioAssay is intended for the qualitative detection in serum of thyroid stimulating autoantibodies to the thyroid stimulating hormone (TSH) receptors (TSHRs) on the thyroid. The detection of these stimulating autoantibodies, in conjunction with other clinical and laboratory findings, may be useful as an aid in the differential diagnosis of patients with Graves' disease (GD).

The number of wells tested per Positive, Reference and Negative control has been reduced from three to two for each. The number of wells tested per patient specimen has been reduced from three to two.

The Diagnostic Hybrids, Inc. device, D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit is intended for the qualitative identification of adenovirus and to screen for the presence of parainfluenza virus types 1, 2, and 3 in nasal and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and symptoms of respiratory infection by direct detection of immunofluorescence using monoclonal antibodies (MAbs). It is recommended that specimens found to be negative for parainfluenza virus and adenovirus after examination of the direct specimen result be confirmed by cell culture. Negative results do not preclude parainfluenza virus and adenovirus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.

The D3 FastPoint L-DFA Parainfluenza Virus/Adenovirus Identification Kit (D3 FastPoint PIV/ADV Kit) uses a blend (called an "L-DFA Reagent") of viral antigen-specific murine monoclonal antibodies that are directly labeled with either R-phycoerythin (PE) (parainfluenza virus types 1, 2 and 3) or fluorescein isothiocyanate (FITC) (adenovirus) for the qualitative identification of adenovirus and to screen for the presence of parainfluenza virus types 1, 2, and 3. The cells to be tested are derived from respiratory specimens from patients with signs and symptoms of respiratory infection. The cells are permeabilized and stained concurrently in a liquid suspension format with the L-DFA Reagent. After incubating at 35℃ to 37℃ for 5-minutes, the stained cell suspensions are rinsed with 1X PBS. The rinsed cells are pelleted by centrifugation and then re-suspended with the Resuspension Buffer and loaded onto a specimen slide well. The cells are examined using a fluorescence microscope. Cells infected with parainfluenza virus types 1, 2 and 3 will exhibit golden-yellow fluorescence. Cells infected with adenovirus will exhibit apple green fluorescence due to the FITC. Non-infected cells will exhibit red fluorescence due to the Evans Blue counter-stain. Nuclei of intact cells will exhibit orange-red fluorescence due to the propidium iodide.

The Diagnostic Hybrids, Inc. device, D3 FastPoint L-DFA RSV/MPV Identification Kit is intended for the qualitative identification of respiratory syncytial virus and human metapneumovirus in nasal and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and symptoms of respiratory infection by direct detection of immunofluorescence using monoclonal antibodies (MAbs). It is recommended that specimens found to be negative for respiratory syncytial virus after examination of the direct specimen result be confirmed by cell culture. Specimens found to be negative for human metapneumovirus after examination of the direct specimen results should be confirmed by an FDA-cleared human metapneumovirus molecular assay. Negative results do not preclude respiratory syncytial virus and human metapneumovirus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.

The D3 FastPoint L-DFA RSV/MPV Identification Kit uses a blend (called a "L-DFA Reagent'") of viral antigen-specific murine monoclonal antibodies that are directly labeled with either R-phycoerythin (PE) (respiratory syncytial virus) or fluorescein isothiocyanate (FITC) (human metapneumovirus) for the rapid identification of respiratory syncytial virus and human metapneumovirus in nasal and nasopharyngeal swabs and aspirates from patients with signs and symptoms of respiratory infection. The cells to be tested are derived from respiratory specimens from patients with signs and symptoms of respiratory infection. The cells are permeabilized and stained concurrently in a liquid suspension format with the L-DFA Reagent. After incubating at 35℃ to 37℃ for 5-minutes, the stained cell suspensions are rinsed with 1X PBS. The rinsed cells are pelleted by centrifugation and then re-suspended with the Resuspension Buffer and loaded onto a specimen slide well. The cells are examined using a fluorescence microscope. Cells infected with RSV will exhibit golden-yellow fluorescence due to the PE. Cells infected with hMPV will exhibit apple-green fluorescence due to the FITC. Non-infected cells will exhibit red fluorescence due to the Evans Blue counter-stain. Nuclei of intact cells will exhibit orange-red fluorescence due to the propidium iodide.

The Diagnostic Hybrids, Inc. device, D3 FastPoint L-DFA Influenza A/Influenza B Virus Identification Kit is intended for the qualitative identification of influenza A virus and influenza B virus in nasal and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and symptoms of respiratory infection by direct detection of immunofluorescence using monoclonal antibodies (MAbs). It is recommended that specimens found to be negative for influenza A or influenza B virus after examination of the direct specimen result be confirmed by cell culture. Negative results do not preclude influenza A or influenza B virus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Performance characteristics for influenza A virus detection and identification were established when influenza A (H3N2) and influenza A (H1N1) were the predominant influenza A strains circulating in the United States. Since influenza strains display antigenic drift and shift from year to year, performance characteristics may vary. If infection with a novel influenza A virus is suspected, based on clinical and epidemiological screening criteria communicated by public health authorities, collect specimens following appropriate infection control precautions and submit to state or local health departments, for testing. Viral culture should not be attempted in these cases unless a BSL 3+facility' is available to receive and culture specimens .

The D3 FastPoint L-DFA Influenza A/Influenza B Virus Identification Kit (D3 FastPoint A/B Kit) uses a blend (called a "L-DFA Reagent") of viral antigen-specific murine monoclonal antibodies that are directly labeled with either R-PE (influenza A virus) or fluorescein (influenza B virus) for the rapid identification of influenza A virus and influenza B virus in nasal and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and symptoms of respiratory infection. The cells to be tested are derived from respiratory specimens from patients with signs and symptoms of respiratory infection. The cells are permeabilized and stained concurrently in a liquid suspension format with the L-DFA reagent. After incubating at 35℃ to 37℃ for 5-minutes, the stained cell suspensions are rinsed with 1X PBS. The rinsed cells are pelleted by centrifugation and then re-suspended with the re-suspension buffer and loaded onto a specimen slide well. The cells are examined using a fluorescence microscope. Cells infected with influenza A virus will exhibit goldenyellow fluorescence due to the PE. Cells infected with influenza B virus will exhibit apple-green fluorescence due to the FITC. Non-infected cells will exhibit red fluorescence due to the Evans Blue counter-stain. Nuclei of intact cells will exhibit orange-red fluorescence due to the propidium iodide.

The Diagnostic Hybrids, Inc. device, D3 FastPoint L-DFA Respiratory Virus Identification Kit is intended for the qualitative identification of influenza A virus, influenza B virus, respiratory syncytial virus, human metapneumovirus, adenovirus and to screen for the presence of parainfluenza virus types 1, 2, and 3 in nasal and nasopharyngeal swabs and aspirates/washes specimens from patients with signs and symptoms of respiratory infection by direct detection of immunofluorescence using monoclonal antibodies (MAbs). It is recommended that specimens found to be negative for influenza A virus, influenza B virus, respiratory syncytial virus, adenovirus or parainfluenza viruses after examination of the direct specimen result be confirmed by cell culture. Specimens found to be negative for human metapneumovirus after examination of the direct specimen results should be confirmed by an FDA cleared human metapneumovirus molecular assay. Negative results do not preclude respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Performance characteristics for influenza A virus detection and identification were established when influenza A (H3N2) and influenza A (H1N1) were the predominant influenza A strains circulating in the United States. Since influenza strains display antigenic drift and shift from year to year, performance characteristics may vary. If infection with a novel influenza A virus is suspected, based on clinical and epidemiological screening criteria communicated by public health authorities, collect specimens following appropriate infection control precautions and submit to state or local health departments, for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

The D3 FastPoint L-DFA Respiratory Virus Identification Kit uses three blends (each called a "L-DFA Reagent") of viral antigen-specific murine monoclonal antibodies that are directly labeled with either R-PE (influenza A virus, respiratory syncytial virus, and parainfluenza virus) or fluorescein (influenza B virus, metapneumovirus, and adenovirus) for the rapid identification of respiratory viruses in nasal and nasopharyngeal swabs and aspirates from patients with signs and symptoms of respiratory infection. Kit Components: 1. D3 FastPoint L-DFA Influenza A/Influenza B Reagent, 4.0-mL. One dropper bottle containing a mixture of PE-labeled murine monoclonal antibodies directed against influenza A virus antigens and FITC-labeled murine monoclonal antibodies directed against influenza B virus antigens. The buffered, stabilized, aqueous solution contains Evans Blue and propidium iodide as counter-stains and 0.1% sodium azide as preservative. 2. D3 FastPoint L-DFA RSV/MPV Reagent, 4.0-mL. One dropper bottle containing a mixture of PE-labeled murine monoclonal antibodies directed against respiratory syncytial virus antigens and FITC-labeled murine monoclonal antibodies directed against metapneumovirus antigens. The buffered, stabilized, aqueous solution contains Evans Blue and propidium iodide as counter-stains and 0.1% sodium azide as preservative. 3. D3 FastPoint L-DFA PIV/Adenovirus Reagent, 4.0-mL. One dropper bottle containing a mixture of PE-labeled murine monoclonal antibodies directed against parainfluenza virus types 1, 2, or 3 antigens and FITClabeled murine monoclonal antibodies directed against adenovirus antigens. The buffered, stabilized, aqueous solution contains Evans Blue and propidium iodide as counter-stains and 0.1% sodium azide as preservative. 4. 40X PBS Concentrate, 25-mL. One bottle of 40X PBS concentrate containing 4% sodium azide (0.1% sodium azide after dilution to 1X using de-mineralized water). 5. Re-suspension Buffer, 6.0-mL. One bottle of a buffered glycerol solution and 0.1% sodium azide. 6. D3 FastPoint L-DFA Respiratory Virus Antigen Control Slides, 5-slides. Five individually packaged control slides containing 6 wells with cell culture-derived positive and negative control cells. Each positive well is identified as to the virus infected cells present, i.e., influenza A virus, influenza B virus, respiratory syncytial virus, metapneumovirus, parainfluenza virus, and adenovirus. The negative wells contain noninfected cells. Each slide is intended to be stained only one time. The cells to be tested are derived from respiratory specimens from patients with signs and symptoms of respiratory infection. The cells are permeabilized and stained concurrently in a liquid suspension format in 3 separate vials, each containing one of the 3 above reagents. After incubating at 35℃ to 37℃ for 5 minutes, the stained cell suspensions are rinsed with 1X PBS. The rinsed cells are pelleted by centrifugation and then re-suspended with the resuspension buffer and loaded onto a specimen slide well. The cells are examined using a fluorescence microscope. Cells infected with influenza A virus, respiratory syncytial virus, or parainfluenza virus types 1, 2 and 3 will exhibit goldenyellow fluorescence due to the PE. Cells infected with influenza B virus, metapnemovirus or adenovirus will exhibit apple-green fluorescence due to the FITC. Non-infected cells will exhibit red fluorescence due to the Evans Blue counter-stain. Nuclei of intact cells will exhibit orange-red fluorescence due to the propidium iodide.

The ELVIS®HSV ID and D3 Typing Test System provides Cells, Replacement Medium and Test Reagents for the culture, qualitative identification and typing of Herpes simplex virus (HSV) from cutaneous or mucocutaneous specimens collected from patients with clinical suspicion of HSV infection. The performance characteristics of this assay have not been established for antiviral therapy, prenatal monitoring or CSF specimens.

The ELVIS®HSV ID and D3 Typing Test System provides Cells, Replacement Medium and Test Reagents for the culture, qualitative identification and typing of herpes simplex virus (HSV) from cutaneous or mucocutaneous specimens as an aid in the diagnosis of HSV type 1 (HSV-1) and HSV type 2 (HSV-2) infections. The performance characteristics of this assay have not been established for antiviral therapy, prenatal monitoring or use with cerebral spinal fluid specimens. ELVIS HSV Cells are genetically engineered Baby Hamster Kidney (BHK) cells, which, when infected with either HSV-1 or HSV-2, are induced to generate and accumulate an endogenous, intracellular bacterial enzyme, ßgalactosidase. Other related viruses (e.g., Varicella zoster) are not capable of inducing the formation of this enzyme. HSV infection of the ELVIS®HSV Cells also results in the formation of HSV-type-specific proteins. The presence of these proteins can be detected microscopically when fluorescent labeled HSV-type-specific antibodies are used. The two Type 1 monoclonal antibodies used in ELVIS® are directed against specific to epitopes on the HSV-1 protein. The three Type 2 monoclonal antibodies are directed against the HSV-2 glycoproteins C, G and a recombinant glycoprotein G that occur in the cytoplasm of infected cells. The ELVIS®HSV ID and D2 Typing Test System consists of: 1. ELVIS®HSV Cells: The ELVIS®HSV Cells have a routine use period of 7 days from customer receipt while all other components have a shelflife of months (see expiration date on label of each component). ELVIS® HSV Cells are provided as 75% to 95% confluent monolavers in shell-vials with or without coverslips, or in multi-well plates with or without coverslips, and up to 24 monolayers per plate. Each monolayer is covered by at least 0.75-mL of Eagle's Minimum Essential Medium (EMEM) with fetal bovine serum (FBS), penicillin, and streptomycin. Cells are characterized by isoenzyme analysis and have been tested and found free of Mycoplasma spp. and other adventitious organisms. 2. ELVIS HSV Replacement Medium: Sterile EMEM containing FBS, Penicillin, Streptomycin and Amphotericin B. ELVIS®HSV Replacement Medium is for use with ELVIS®HSV Shell-Vials and Multi-well Plates. 3. ELVIS® HSV Solution 1 (Cell Fixative): an aqueous acetone solution. 4. ELVIS® HSV Solution 2T (Staining Buffer): A diluted solution of X-Gal (5-Bromo-4-Chloro-3-Indolyl-B-D-Galactopyranoside), N.N-Dimethylformamide, iron, sodium and magnesium salts, fluorescein-labeled HSV-2-specific murine MAbs (directed against HSV-2 glycoproteins C, G, and a recombinant glycoprotein G) and nonlabeled HSV-1-specific murine MAbs (specific to epitopes on the HSV-1 protein UL42), penicillin, streptomycin, bovine serum albumin and Evans Blue in an aqueous, buffered solution. 5. ELVIS®HSV Solution 3: An aqueous, stabilized, buffered solution containing fluorescein-labeled, affinity purified goat-anti-mouse IgG antibody and Evans Blue with sodium azide as preservative. 6. ELVIS®HSV Mounting Fluid (Buffered Glycerol): Aqueous, stabilized, buffered glycerol (pH 7.3 +/- 0.5), containing sodium azide as preservative. 7. 40X PBS Concentrate. 25-mL: One bottle of a 40X PBS concentrate consisting of 0.4% sodium azide (0.1% sodium azide after dilution to 1X using de-mineralized water).

The Diagnostic Hybrids. Inc. D Ultra DFA (direct fluorescent antibody) Respiratory Virus Screening & ID Kit is intended for the qualitative detection and identification of the Influenza A. Influenza B, Respiratory Syncytial Virus (RSV), Adenovirus, Parainfluenza 1, Parainfluenza 2 and Parainfluenza 3 virus in respiratory specimens, by either direct detection or cell culture method, by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). It is recommended that specimens found to be negative after examination of the direct specimen result be confirmed by cell culture. Negative results do not preclude respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. - Performance characteristics for influenza A were established when influenza A/H3 and A/H1 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. - If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL3+ facility is available to receive and culture specimens.

The Diagnostic Hybrids, Inc. D3 Ultra DFA RESPIRATORY VIRUS SCREENING & ID KIT uses viral antigen-specific murine monoclonal antibodies that are directly labeled with fluorescein for the rapid detection and identification of respiratory viruses. The kit includes a DFA Screening Reagent that contains a blend of murine monoclonal antibodies (MAbs) directed against seven respiratory viruses (Influenza A, Influenza B, Respiratory Syncytial Virus, Adenovirus, Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3) plus seven separate DFA Reagents, each consisting of MAb blends directed against a single respiratory virus. The kit can be used for direct specimen or cell culture screening and final virus identification. The cells to be tested, either derived from a clinical specimen or cell culture, are fixed in acetone. The DFA Screening Reagent is added to the cells to determine the presence of viral antigens. After incubating at 35℃ to 37℃, the stained cells are rinsed with the diluted Wash Solution. A drop of the supplied Mounting Fluid is added and a coverslip is placed on the prepared cells. The cells are examined using a fluorescence microscope. Virus infected cells will be stained with viral specific apple-green fluorescence when stained with the DFA Screening Reagent while uninfected cells will contain no fluorescence but will be stained red by the Evan's Blue counter-stain. If the specimen contains fluorescent cells, the particular virus is identified using the separate DFA Reagents on new, separate cell preparations.

The Thyretain ™ TSI Reporter BioAssay is intended for the qualitative detection in serum of thyroid stimulating autoantibodies to the thyroid stimulating hormone (TSH) receptors (TSHRs) on the thyroid. The detection of these stimulating autoantibodies, in conjunction with other clinical and laboratory findings, may be useful as an aid in the differential diagnosis of patients with Graves' disease (GD).

The Thyretain ™ TSI Reporter BioAssay (TSI Reporter) utilizes a patented bioassay technology to detect thyroid stimulating immunoglobulin (TSI) in human serum. Genetically engineered Chinese hamster ovary (CHO) cells, expressing a chimeric form' of the human thyroid stimulating hormone receptor (TSHR) and a cyclic adenosine monophosphate (cAMP) induced luciferase reporter gene, are cryogenically preserved and provided in measured aliquots. The CHO Mc4 cell line has a nucleic acid sequence encoding a chimeric human TSH receptor, designed for reduced response to thyroid blocking immunoglobulin (TBI) activity. Thus, the hTSH receptor, comprised of 730 amino acids, has amino acid residues 262 to 335 replaced by the equivalently located 73 amino acid residues of the rat Luteinizing Hormone receptor to form the chimeric TSHR. This chimeric receptor is linked to a firefly luciferase reporter gene in operable combination with a glycoprotein hormone a-subunit promoter. The cells are seeded and grown for 15 to 18 hours to confluent monolayers in a 96-well plate. Patient sera, reference control, positive and normal controls and are diluted with a proprietary reaction buffer (RB), added to the cell monolayers and allowed to react with the cells for 3 hours. During this induction period TSI, if present in the patient serum, bind to the chimeric human TSHR on the cell surface. This binding event induces a signaling cascade resulting in increased production of intra-cellular cAMP. This increased production of cAMP is evidenced by increased production of luciferase. At the conclusion of the 3 hour induction period the cells are lysed. Luciferase levels are then measured using a luminometer. A significant increase in luminescence over the Reference Control indicates the presence of TSI antibodies in the sample.

The Diagnostic Hybrids, Inc. device, D3 DFA Metapneumovirus Identification Kit, is intended for the qualitative detection and identification of human metapneumovirus (hMPV) in nasal and nasopharyngeal swabs and aspirates/washes or cell culture. The assay detects hMPV antigens by immunofluorescence using a blend of three monoclonal antibodies (MAbs), from patients with signs and symptoms of acute respiratory infection. This assay detects but is not intended to differentiate the four recognized genetic sub-lineages of hMPV. Negative results do not preclude hMPV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. It is recommended that specimens found to be negative after examination of the direct specimen results be confirmed by an FDA cleared hMPV molecular assay.

The D DFA Metapneumovirus Identification Kit uses a blend of three hMPV antigen-specific murine MAbs that are directly labeled with fluorescein for detection of hMPV. The reagent detects but does not differentiate between the four recognized subtypes of hMPV (subtypes A1, A2, B1, and B2). Kit Components: - 1. Metapneumovirus DFA Reagent, 5-mL. One dropper bottle containing a blend (see below for MAb discussion) of fluorescein-labeled murine monoclonal antibodies directed against MPV. The buffered, stabilized, aqueous solution contains Evans Blue as a counter-stain and 0.1% sodium azide as a preservative. - 2. hMPV Antigen Control Slides, 5 slides. Five individually packaged control slides, each with a well containing cell culture-derived MPV positive cells and a well containing cell culture-derived negative cells. Each slide is intended to be stained only one time. Control material has been treated to be non-infectious; however normal laboratory precautions are required when the material is handled. - 3. 40X PBS Concentrate, 25-mL. One bottle containing a 40X concentrate consisting of 4% sodium azide (0.1% sodium azide after dilution to 1X using de-mineralized water) in PBS. - 4. Mounting Fluid, 7-mL. One dropper bottle containing an aqueous, buffer-stabilized solution of glycerol and 0.1% sodium azide. The cells to be tested, derived from a clinical specimen or cell culture, are placed onto a glass slide, allowed to air dry and are fixed in acetone. The Metapneumovirus DFA Reagent is added to the cells which are then incubated for 15 to 30 minutes at 35℃ to 37℃ in a humidified chamber or humidified incubator. The stained cclls are then washed with the diluted phosphate buffered saline (PBS), a drop of the supplied Mounting Fluid is added and a coverslip is placed on the prepared cells. The cells are examined using a fluorescence microscope. The hMPV infected cells will fluoresce apple-green. Uninfected cells will contain no fluorescence but will be stained red by the Evans Blue counter-stain. It is recommended that specimens found to contain no fluorescent cells after examination of the direct specimen be confirmed by an FDA cleared hMPV molecular assay.