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The Access Syphilis assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of total antibodies to Treponema pallidum in human serum and plasma using the Access lmmunoassay Systems. It is intended to be used as an aid in the diagnosis of syphilis or in conjunction with a nontreponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection. The Access Syphilis assay is not intended for blood and tissue donor screening.

The Access Syphilis assay is a two-step enzyme immunoassay. A sample is added to a reaction vessel with buffer, paramagnetic particles coated with recombinant Treponema pallidum antigens Tp17 and Tp47, and Tp47, and biotinylated Treponema Tp17 & Tp47 antigens. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Alkaline phosphatase conjugates are added, and the conjugates bind to the immunoglobulin captured on the particles. A chemilyminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is proportional to the amount of Treponema pallidum antibodies in the sample. The light quantity measured for a sample allows a determination of the presence of the analyte by comparison with a cut-off value defined during the assay calibration on the instrument. The Access Syphilis reagents are provided in liquid ready-to-use format designed for optimal performance on the Beckman Coulter Access Immunoassay Systems. Each reagent kit contains two reagent packs.

For the qualitative determination of total (IgG and IgM) antibodies to Treponema pallidum (TP) specific antigens in human serum and plasma using the VITROS 5600 Integrated System. The presence of antibodies to Treponema pallidum (TP) specific antigens, in conjunction with non-treponemal laboratory tests and clinical findings may aid in the diagnosis of syphilis infection. The VITROS Syphilis test is not intended for blood and tissue donor screening.

The VITROS Immunodiagnostic Products Syphilis test is performed using the VITROS Immunodiagnostic Products Syphilis Reagent Pack and VITROS Immunodiagnostic Products Syphilis Calibrator on the VITROS 5600 Integrated System. An immunometric technique is used; this involves a two-stage reaction. In the first stage antibodies to Syphilis TP specific antigens present in the sample bind with biotinylated recombinant Syphilis TP antigens immobilized on streptavidin coated wells. Unbound sample is removed by washing. In the second stage conjugate reagent containing horseradish peroxidase (HRP)-labeled recombinant Syphilis TP antigens is added. The conjugate binds specifically to any antibody to Syphilis TP specific antigens captured on the well in the first stage. Unbound conjugate is removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system.

Immunoassay for the in vitro qualitative detection of total antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma. The test is intended as an aid in the diagnosis of syphilis infection in conjunction with clinical signs and symptoms. The Elecsys Syphilis immunoasay is not in screening blood or tissue donors. The effectiveness of this assay in testing blood or tissue donors has not been established. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

The Elecsys Syphilis immunoassay is a fully automated, qualitative assay that uses a double antigen sandwich format for the detection of IgM and IgG antibodies to T. pallidum. Recombinant T. pallidum antigens labeled with either biotin or a ruthenium complex bind to T. pallidum-specific IgG or IgM to form a double antigen sandwich complex. The sandwich complex binds to streptavidin-coated microparticles which can be immobilized magnetically to the surface of an electrode. Unbound substances are removed during a wash step using ProCell. A chemiluminescent substrate is then added to the reaction tube. Application of a voltage to the electrode induces a chemiluminescent emission which is measured by a photomultiplier. The presence or absence of anti-TP antibodies in the specimen is determined by comparing the chemiluminescent signal in the reaction to the cutoff index (COI) determined from an active calibration. The strength of the signal generated is proportional to the amount of bound conjugate and thus the amount of anti-T. pallidum antibodies present in the specimen. If the chemiluminescent signal in the reaction is greater than or equal to the cutoff signal, the specimen is considered reactive for anti-TP antibodies. If the chemiluminescent signal is below the cutoff signal, the specimen is considered nonreactive for the anti-TP antibodies.

The BioPlex Syphilis Total & RPR kit is a multiplex flow immunoassay intended for the qualitative detection of total (IgG/IgM) antibodies to Treponema pallidum and the qualitative detection and/or titer determination of non-treponemal reagin antibodies in human serum or plasma. The Syphilis Total or RPR assays may be used to supplement a previously determined reactive treponemal or non-treponemal test. The test system should be used in conjunction with other laboratory tests and clinical findings to aid in the diagnosis of syphilis infection. The BioPlex 2200 Syphilis Total & RPR kit is not intended for use in screening blood or plasma donors The BioPlex 2200 Syphilis Total & RPR kit is intended for use with the Bio-Rad BioPlex 2200 System. The BioPlex 2200 Syphilis Total & RPR Control Set is intended for use as an assayed quality control to monitor the performance of the BioPlex 2200 Instrument and BioPlex 2200 Syphilis Total & RPR assay in the clinical laboratory. The performance of the BioPlex 2200 Syphilis Total & RPR Control Set has not been established with any other Syphilis Total & RPR assays. The BioPlex 2200 Syphilis Total & RPR Calibrator Set is intended for the BioPlex 2200 Syphilis Total & RPR Reagent Pack.

BioPlex 2200 Syphilis Total & RPR kit includes the following components: - One (1) 10 mL vial, containing dyed beads coated with recombinant Syphilis ● rTP47/rTP17 fusion protein, a cardiolipin antigen, an Internal Standard Bead (ISB) and a Serum Verification Bead (SVB) in MOPS (3-[N-Morpholino] propanesulfonic acid) buffer containing bovine proteins with protein stabilizers. ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) are added as preservatives. - One (1) 5 mL vial, containing phycoerythrin conjugated murine monoclonal antihuman IgG and murine monoclonal anti-human IgM, and phycoerythrin conjugated murine monoclonal anti-human FXIII antibody in phosphate buffer supplemented with murine and bovine protein stabilizers. ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) are added as preservatives. - One (1) 10 mL vial, containing bovine and murine protein stabilizers in MOPS (3-IN-Morpholino] propanesulfonic acid) buffer. ProClin 300 (< 0.3%), sodium benzoate (< 0.1%) and sodium azide (< 0.1%) are added as preservatives BioPlex 2200 Syphilis Total & RPR Calibrator Set: Four (4) 0.5 mL vials, containing T. pallidum and reagin antibodies in a human serum matrix made from defibrinated plasma, and one (1) 0.5 mL vial containing human serum matrix made from defibrinated plasma for a total of five (5) calibrator vials. All calibrators contain ProClin 300 (≤ 0.3%), sodium benzoate (< 0.1%) and sodium azide (< 0.1%) as preservatives BioPlex 2200 Syphilis Total & RPR Control Set: Two sets of three (3) control vials. Each set contains two (2) 1.5 mL Positive Control vials with antibodies to T. pallidum and reagin in a human serum matrix made from defibrinated plasma and one (1) 1.5 mL vial of Negative Control in a human serum matrix made from defibrinated plasma. ProClin 300 (≤ 0.3%) sodium benzoate (< 0.1%) and sodium azide (< 0.1%) are added as preservatives for all controls. Additional materials required but not supplied include BioPlex 2200 Sheath Fluid containing Phosphate Buffered Saline (PBS), ProClin 300 (0.03%) and sodium azide (<0.1%) as preservatives; and BioPlex 2200 Wash Solution containing Phosphate Buffered Saline (PBS) and Tween 20. ProClin 300 (0.03%) and sodium azide (<0.1%) as preservatives.

Immunoassay for the in vitro qualitative detection of total antibodies (IgG and IgM) to Treponema pallidum in human serum and plasma. The test is intended as an aid in the diagnosis of syphilis infection with clinical signs and symptoms. The Elecsys Syphilis immunoassay is not intended for use in screening blood or tissue donors. The effectiveness of this assay in testing blood or tissue donors has not been established. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 analyzer. PreciControl Syphilis is intended for the quality control of the Elecsys Syphilis immunoassay on the cobas e 411 analyzer.

The Elecsys Syphilis assay is a fully automated qualitative assay detecting IgG and IgM antibodies to Treponema pallidum, the causative agent of syphilis. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of active or previous infection with Treponema pallidum in persons with signs and symptoms of syphilis, as well as in patients at risk for syphilis infection. This assay does not determine the stage of infection or associated disease. PreciControl Syphilis is a lyophilized control based on human serum. It is used for monitoring the accuracy of the Elecsys Syphilis immunoassay.

Lumipulse G TP-N Immunoreaction Cartridges Set For in vitro diagnostic use. WARNING: Lumipulse G TP-N is not intended for blood and tissue donor screening. United States federal law restricts this device to sale by or on the order of a physician. Lumipulse G TP-N is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the qualitative determination of antibodies (1gG and 1gM) to Treponema pallidum in human serum and plasma (sodium citrate, or dipotassium EDTA) on the LUMIPULSE & System. Lumipulse G TP-N can be used as an initial diagnostic test or in conjunction with a nontreponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection.

The Lumipulse G TP-N is an assay system, including a set of immunoassay reagents, for the qualitative detection of anti-TP antibodies (IgG and IgM) in specimens based on CLEIA technology by a two-step sandwich immunoassay method on the LUMIPULSE G System.

The ARCHITECT Syphilis TP assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of antibodies (IgG and IgM) directed against Treponema pallidum (TP) in human serum and plasma. The ARCHITECT Syphilis TP assay is intended to be used as an initial diagnostic test or in conjunction with a nontreponemal laboratory test and clinical findings to aid in the diagnosis of syphilis infection. Warning: The ARCHITECT Syphilis TP assay is not intended for use in screening blood, plasma, or tissue donors. The effectiveness of the ARCHITECT Syphilis TP assay for use in screening blood, plasma, or tissue donors has not been established. The ARCHITECT Syphilis TP Calibrator is for the ARCHITECT iSystem when used for the qualitative detection of antibody to Treponema pallidum (TP) in human serum and plasma. The ARCHITECT Syphilis TP Controls are for the estimation of test precision of systematic analytical deviations of the ARCHITECT iSystem when used for the qualitative detection of antibody to Treponema pallidum (TP) in human serum and plasma.

The ARCHITECT Syphilis TP assay is a two-step immunoassay for the qualitative detection of antibodies (IgG and IgM) directed against TP in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. 1. Sample, assay diluent, and recombinant TP antigen (TpN15, TpN17 and TpN47) coated microparticles are combined. Anti-TP antibodies present in the sample bind to the TP coated microparticles. 2. After washing, anti-human IgG and IgM acridinium-labeled conjugate is added to create a reaction mixture. 3. Following another wash cycle, Pre-Trigger and Trigger Solutions are added to the reaction mixture. 4. The resulting chemiluminescent reaction is measured as relative light units (RLUs). There is a direct relationship between the amount of anti-TP antibodies in the sample and the RLUs detected by the ARCHITECT iSystem optics. The presence or absence of anti-TP antibodies in the specimen is determined by comparing the chemiluminescent signal in the reaction to the cutoff signal determined from an active calibration. If the chemiluminescent signal in the reaction is greater than or equal to the cutoff signal, the specimen is considered reactive for anti-TP antibodies.

The BioPlex® 2200 EBV IgG kit is a multiplex flow immunoassay intended for the qualitative detection of IgG antibodies to three (3) separate EBV antigens; Epstein-Barr Virus Nuclear Antigen-1 (EBV NA-1), Viral Capsid Antigen (EBV VCA), and Early Antigen diffuse (EBV EA-D) in human serum. The test system can be used in conjunction with the BioPlex 2200 EBV IgM kit as an aid in the laboratory diagnosis of infectious mononucleosis (IM). The EBV IgG kit is intended for use with the Bio-Rad BioPlex 2200 System. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, neonatal specimens, or infants. Assay performance characteristics have not been established for the diagnosis of nasopharyngeal carcinoma, Burkitt's lymphoma, and other EBV-associated lymphomas. The BioPlex® 2200 Syphilis IgG kit is a multiplex flow immunoassay intended for the qualitative detection of Treponema pallidum IgG antibodies in human serum. The test system, when used in conjunction with non-treponemal based assays, provides serological evidence of infection with T. pallidum. This test system also confirms reactive test results form non-treponemal based screening assays. The Syphilis IgG kit is intended for use with the Bio-Rad BioPlex 2200 System. The BioPlex 2200 Syphilis IgG kit is not intended for use in screening blood or plasma donors Warning: A positive result is not useful for establishing a diagnosis of Syphilis. In most situations, such a result may reflect prior treated infection; a negative result can exclude a diagnosis of syphilis except for incubating or early primary disease.

The EBV IgG kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional ElA, but permits simultaneous detection and identification of many antibodies in a single tube. Three (3) different populations of beads are coated with E. coli derived recombinant proteins, EBV NA-1 (28kD and 45kD), EBV VCA p18 (40kD), and EBV EA-D (28kD) associated with infectious mononucleosis. The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, antihuman IgG antibody, conjugated to phycoerythrin (PE), is added to the dyed beads and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data is calculated in relative fluorescence intensity (RFI). Three additional dyed beads, an Internal Standard Bead (ISB), a Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum or plasma to the reaction vessel and the absence of significant non-specific binding in serum or plasma. Refer to the BioPlex 2200 System Operation Manual for more information. The instrument is calibrated using a set of seven (7) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. A combination of four (4) vials representing four (4) different antibody concentrations are used for semiquantitative calibration. The result for each of these antibodies is expressed as an antibody index (AI). The Syphilis IgG kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional ElA, but permits simultaneous detection and identification of many antibodies in a single tube. Three (3) different populations of beads are coated with recombinant proteins associated with T. pallidum (15kD. 17kD. and 47kD). The BioPlex 2200 System combines an aliquot of patient sample diluent, and bead reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, anti-human IgG antibody, conjugated to phycoerythrin (PE), is added to the dyed beads and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data is calculated in relative fluorescence intensity (RFI). Three additional dyed beads, an Internal Standard Bead (ISB), a Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum or plasma to the reaction vessel and the absence of significant non-specific binding in serum or plasma. Refer to the BioPlex 2200 System Operation Manual for more information. The system is calibrated using a set of four (4) distinct calibrator vials, supplied separately by Bio-Rad Laboratories. Four (4) vials representing two (2) or three (3) different antibody concentrations are used for calibration. Results are calculated for each of the three (3) antibodies and are compared against their own respective cut-off and are expressed as an antibody index (AI). A single result is reported after completing a composite analysis of all the antibodies (the highest AI value is reported).

The ADVIA Centaur Syphilis (SYPH) assay is an in-vitro diagnostic immunoassay for the qualitative determination of antibodies to Treponema pallidum in human serum or plasma (EDTA. lithium or sodium heparinized, citrate) using the ADVIA Centaur® and ADVIA Centaur® XP systems as an aid in the diagnosis of syphilis. The ADVIA Centaur Syphilis assay is not intended for blood and tissue donor screening. ADVIA® Centaur Syphilis Quality Control Materials are for in-vitro diagnostics use to monitor the performance of the Syphilis assay on the ADVIA Centaur® systems. The performance of the SYPH quality control material has not been established with any other Syphilis assay.

The ADVIA Centaur syphilis assay is a fully automated, antigen sandwich assay, using direct chemiluminometric technology. The ancillary pack reagent containing acridinium-ester-labeled T. pallidum recombinant antigens is added to the sample. These T. pallidum antigens complex with the antibodies in the sample. The solid phase containing biotinylated T. pallidum recombinant antigens preformed to streptavidin-coated magnetic latex particles, is then added to the sample. These particles capture the T. pallidum antigen-antibody complexes. Antibody-antigen complexes will form if Syphilis antibodies are present in the sample. A direct relationship exists between the level of antibodies to T. pallidum present in the patient sample and the amount of relative light units (RLUs) detected by the system. A result of reactive, nonreactive, or equivocal is determined according to the Index Value established with the calibrators. The Syphilis kit contains the following: - 1 ReadyPack® primary reagent pack containing ADVIA Centaur Syphilis Solid Phase Reagent (20 mL); - 1 Ancillary pack containing ADVIA Centaur Syphilis Ancillary Reagent (10mL) - ADVIA Centaur Syphilis Master Curve card - 2 vials of Syphilis Low Calibrator (2 mL fill volume) - 2 vials of Syphilis High Calibrator (2 mL fill volume) - ADVIA Centaur Syphilis Calibrator Assigned Value cards In addition Syphilis quality control materials (2 vials of negative control and 2 vials of positive control with 7 mL fill volume each) are provided separately.

Syphilis Health Check is a qualitative rapid membrane immunochromatographic assay for the detection of Treponema pallidum (syphilis) antibodies in human whole blood, serum or plasma. This product can be used as an initial screening test or in conjunction with a non-treponemal laboratory test and clinical findings, may aid in the diagnosis of syphilis infection. This test is not intended for use in screening blood or plasma donors.

SYPHILIS HEALTH CHECK is a rapid qualitative screening test for detection of human antibodies to TP in serum, plasma or whole blood. The method employs an unique combination of anti-human immunoglobulins gold conjugate and highly purified TP recombinant proteins to specifically detect anti-TP antibodies. The test mainly detects IgG and IgM will also react in case of high concentrations. As the samples flow through the absorbent device, the anti-human immunoglobulins/protein A dye conjugate binds to the human immunoglobulins forming an antigen-antibody complex. This complex binds to the recombinant protein in the positive reaction zone and produces a pink-rose colored band. In the absence of anti TP antibodies, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device past the reaction and control zones. Unbound conjugate binds to the reagents in the control zone producing a pink-rose color band, demonstrating that the reagents are functioning correctly.