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The BioPlex 2200 Lyme Total kit is a multiplex flow immunoassay intended for the qualitative detection of total (lgM/IgG) antibodies to Borrelia burgdorferi in human serum and plasma (EDTA, heparin). This assay should be used to test patients with a history and/ or symptoms of infection with B. burgdorferi. The BioPlex 2200 Lyme Total assay is intended for use with the Bio-Rad BioPlex 2200 System. All reactive and equivocal specimens should be tested with a second tier test such as Lyme IgM and IgG Western blot assays. Positive second tier results are supportive evidence of infection with B. burgdorferi. Diagnosis of Lyme borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Non-reactive first tier or negative second tier results should not be used to exclude borreliosis.

BioPlex 2200 Lyme Total kit includes the following components: - One (1) 10 mL vial of Bead Set , containing dyed beads coated with recombinant p58, OspC ● type B (OspCB) and synthetic peptide FVlsE (consisting of FlaB and VlsE sequences), an Internal Standard bead (ISB) and a Serum Verification bead (SVB) in MOPS (3-[N-Morpholino] propane sulfonic acid) buffer containing bovine proteins with protein stabilizers. BND (5-bromo-5-nitro-1,3-dioxan) (≤ 0.1%), ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) are added as preservatives. - One (1) 5 mL vial of Conjugate, containing phycoerythrin conjugated murine monoclonal anti-. human 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%) and sodium azide (< 0.1%) are added as preservatives. - One (1) 10 mL vial of Sample Diluent, containing bovine and murine proteins in ● triethanolamine buffer. ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) are added as preservatives. Additional materials required but not supplied include BioPlex 2200 Sheath Fluid containing Phosphate Buffered Saline (PBS) with ProClin 300 (0.03%) and sodium azide (<0.1%) added as preservatives; and the BioPlex 2200 Wash Solution containing Phosphate Buffered Saline (PBS) and Tween 20 with ProClin 300 (0.03%) and sodium azide (<0.1%) added as preservatives.

The QXDx™ BCR-ABL %IS Kit is an in vitro nucleic acid amplification test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed (9;22) positive Chronic Myeloid Leukemia (CML) patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The QXDx BCR-ABL %IS Kit is a reverse transcription-quantitative PCR performed on the Bio-Rad QXDx™ AutoDG™ ddPCR System and is intended to measure BCR-ABL1 to ABL1, expressed as a log molecular reduction (MR value) from a baseline of 100% on the International Scale, in (9;22) positive CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs). The QXDx BCR-ABL %IS Kit is intended for use only on the Bio-Rad QXDx AutoDG ddPCR System. The test does not differentiate between e13a2 or e14a2 fusion transcripts and does not monitor other rare fusion transcripts resulting from t(9;22). This test is not intended for the diagnosis of CML.

The QXDx AutoDG ddPCR System consists of two instruments, the QXDx Automated Droplet Generator and the QXDx Droplet Reader, and their associated consumables. The QXDx Automated Droplet Generator partitions samples into approximately 20,000 nanoliter-sized droplets and, after PCR on a thermal cycler, droplets from each sample are analyzed individually on the QXDx Droplet Reader. PCR-positive and PCR-negative droplets are counted to provide direct quantification of nucleic acid in digital form. Results are analyzed on QXDx Software running on a Windows based computer. The QXDx AutoDG ddPCR System contains: - QXDx Automated Droplet Generator ● - QXDx Droplet Reader ● - Laptop Computer with QXDx Software . - Accessory components: ● - o ddPCR Dx AutoDG Consumable Pack - Automated Droplet Generation Oil for Probes ■ - DG32 Cartridges w/ Gaskets ■ - ddPCR Pipet Tips - . ddPCR 96 Well Plates - . ddPCR Pierceable Foil Seals - o ddPCR Dx AutoDG Droplet Reader Oil Pack Components of the kit QXDx BCR-ABL %IS KIT: - QXDXTM BCR-ABL primers & probes - QXDXTM Nuclease Free Water - QXDXTM iScript Advanced Reverse Transcriptase - QXDXTM 5x iScript Select Reaction Mix - QXDXTM RT Primers - QXDXTM 2X ddPCRTM Supermix - QXDXTM BCR-ABL ~0.1%IS - QXDXTM BCR-ABL ~10%IS - QXDXTM BCR-ABL Neg-CTRL - QXDXTM BCR-ABL H-CTRL - QXDXTM BCR-ABL L-CTRL

The BioPlex 2200 25-OH Vitamin D Kit is a multiplex flow competitive immunoassay intended for the quantitative determination of 25-hydroxyvitamin D in human serum. The BioPlex 2200 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency. The BioPlex 2200 25-OH Vitamin D kit is intended for use with the Bio-Rad BioPlex 2200 System.

BioPlex 2200 25-OH Vitamin D kit includes the following components: - One (1) 10 mL vial of Bead Set containing dyed beads coated with anti-25-0H ● Vitamin D antibody (sheep), an Internal Standard bead (ISB), and a Serum Verification bead (SVB) in buffer with protein stabilizers (bovine). ProClin 950 (< 1.0%) and sodium azide (< 0.1%) as preservatives. - One (1) 10 mL vial of Release Buffer containing 25-OH Vitamin D releasing reagents in citrate and tri sodium citrate acid buffer at pH 4.1 and ProClin 950 (<1.0%) as preservative. - One (1) 5 mL vial of Conjugate 1 containing biotinylated 25-OH Vitamin D . conjugate and biotinylated anti-human FXIII antibody conjugate (murine) in buffer with protein stabilizers (bovine). ProClin 950 (< 1.0%) and 5-bromo-5nitro-1, 3-dioxane (<0.1%) as preservatives and chemical blockers. - . One (1) 5 mL vial of Conjugate 2 containing phycoerythrin conjugated streptavidin (SA-PE) in a buffer comprising protein stabilizers (bovine). ProClin 950 (< 1.0%) and sodium azide (< 0.1%) as preservatives, chemical blockers and detergent (Tween 20). 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.

The Hemoglobin Variants System is intended as a qualitative screen for the presence of hemoglobins F, A, S, D, C and E in eluates of neonatal blood collected on filter paper by high-performance liquid chromatography (HPLC). The Hemoglobin Variants System is intended for Professional Use Only. For in vitro diagnostic use. The Hemoglobin Variants System is for use only with the Newborn Hemoglobin System (NHS). This device, consisting of the reagents, controls, apparatus, HPLC instrumentation, software is indicated for professional laboratory IVD use to isolate and identify inherently determined abnormal (S, D, C, E) and normal (F, A) hemoqlobin types in neonatal blood samples.

The instrument, Newborn Hemoglobin System (NHS) utilizes same principles of ionexchange high-performance liguid chromatography (HPLC). The NHS instrument is a fully automated, high-throughput hemoglobin analyzer. It utilizes principles of ion-exchange highperformance liquid chromatography (HPLC). The NHS provides an integrated method for the separation and determination of relative percent of specific hemoglobins of dried blood spots. The dried blood spot collected from neonatal heel stick is punched and eluted with deionized water. The punched disc is removed and eluted sample is transferred into microplate well. The eluted sample is analyzed to identify specific inherently abnormal (S, D, C, E) as well as normal (F, A) hemoglobins through the system. The NHS consists of two modules — the Newborn Chromatographic Station (NCS) and the Newborn Auto Sampler (NAS). NCS module delivers buffer solutions (See table 4 for kit components) to the Hemoglobin Variants System CE Mini-Columns and the detector. The NAS module through automatic injection introduces eluted sample from microplate wells. Each sample is processed individually. The mini-column contains a cation exchange gel, and the analyzer makes use of a continuous pre-programmed gradient system. The preprogrammed gradient is designed to have the hemoglobins of interest elute from the minicolumn with retention times that fall within pre-determined windows characteristic of known normal and abnormal hemoglobins. The ionic strength of two phosphate buffers passing through the mini-column is changed over three minutes. The eluted hemoglobins introduced through automatic injection are sequentially detected with a dual-wavelength filter photometer. which monitors hemoglobin absorbance at 415 nm and corrects for any gradient induced absorbance changes at 690 nm. Detection is performed at two wavelengths (415 nm and 690 nm) to ensure a stable baseline. Sample of water immediately following a newborn or quality control sample prevents carryover. A workstation is used to control the Newborn Hemoglobin System using Genetic Disease Management (GDM) software. The GDM software is designed to execute the assay protocol on the NHS instrument using the Hemoglobin Variants System reagent kit components. The software processed HPLC data is outputted in a printed report that contains: 1) sample identification, 2) date and time of analysis, 3) report data (i.e., peak names, retention times, area, relative percent), and 4) chromatogram. Also system assigns a presumptive phenotype "pattern" to each sample result. The pattern is calculated by applying a set of "rules" to the peaks identified in the peak table. The purpose of the pattern rules is to eliminate minor peaks from the pattern, identify system or sample problems, and to focus the operator on the samples that may require further investigation. The pattern rules used by the GDM software were derived from those generated by the Genetic Diseases Laboratory for the state of California, USA, after analysis of 2.5 million newborns by HPLC over a four year period (Eastman, et al., 1996)'. Laboratories using the Newborn Hemoglobin System pattern rules and assignment should perform an internal validation study to confirm the performance of the system for their application. 1.Eastman, J. W.; Wong, R.; Liao, C. L.; Morales, D. R. Automated HPLC Screening of Newborns for Sickle Cell Anemia and Other Hemoglobinopathies. Clin. Chem. 1996, 42 (5), 704—710. The HbReview Software is to support the review of transmitted result and release of an approved result for each neonate sample analyzed on Hemoglobin Variants System with Newborn Hemoglobin System. A screening site using Newborn Hemoglobin Systems (NHS) transmits results from the Genetic Disease Management (GDM) software to the central site. The central site uses HbReview software to review results, identify samples for retesting, add comments and release results to the reporting site. Features are provided to assist Reviewers and Approvers in their tasks of examining results from the Hemoglobin Newborn Screening test. The HbReview software is a Client-Server design. The Review process provides a user interface (client) to a relational database, which is located on a separate computer (the server). The Client software permits an authorized user to make changes to the data maintained on the Server.

The BioPlex 2200 ToRC IgM kit is a multiplex flow immunoassay intended for the qualitative detection of IgM antibodies to Toxoplasma gondii), Rubella, and Cytomegalovirus (CMV) in human serum and plasma (K3 EDTA, lithium heparin, or sodium heparin). The BioPlex 2200 ToRC IgM kit is intended for use with the Bio-Rad BioPlex 2200 System. This kit is intended as an aid in the diagnosis of a current or recent T. gondii, Rubella and/or CMV infection, in individuals suspected of having one of the respective disease states, including women of child bearing age. This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors. Performance characteristics for the ToRC IgM assay have not been evaluated in immunosuppressed or organ transplant individuals. Performance characteristics of this kit have not been established for use in neonatal screening or for use at point of care facilities. The BioPlex 2200 ToRC IgM Calibrator Set is intended for the BioPlex 2200 ToRC IgM Reagent Pack. The BioPlex 2200 ToRC IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 ToRC IgM Reagent Pack in the clinical laboratory.

BioPlex ToRC IgM Reagent Pack includes the following components: - One (1) 10 mL vial, containing dyed beads coated with lysates of T. gondii, Rubella and CMV ● plus an Internal Standard bead (ISB) and a Serum Verification bead (SVB) in buffer with Glycerol and protein stabilizers (bovine and caprine). ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) as preservatives. - . One (1) 5 mL vial, containing phycoerythrin-conjugated murine monoclonal anti-human IgM antibody and phycoerythrin-conjugated murine monoclonal anti-human FXIII antibody, in buffer with protein stabilizers (bovine and murine). ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) as preservatives. - One (1) 10 mL vial, containing goat anti-human IgG antibody and protein stabilizers (bovine . and murine) in buffer. ProClin 300 (< 0.3%), sodium benzoate (< 0.1%) and sodium azide (< 0.1%) as preservatives. BioPlex 2200 ToRC IgM Calibrator set contains two (2) 0.5 mL vials. The calibrators are provided in a human serum matrix made from defibrinated plasma with added known analyte concentrations consisting of HuCAL® recombinant IgM antibodies for rubella and human disease state plasma derived antibodies for T. gondii and CMV. All calibrators contain ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) as preservatives. BioPlex 2200 ToRC IgM Control set contains two (2) 1.5 mL Positive Control serum vials, containing human disease state plasma derived IgM antibodies to T. gondii and CMV, and HuCAL® recombinant IgM antibodies to Rubella in a human serum matrix made from defibrinated plasma; and two (2) 1.5 mL Negative Control serum vials, in a human serum matrix made from defibrinted plasma. All controls contain Amikacin (0.003%), Cycloheximide (C15H23NO4) (0.009%), Amphotericin B (0.002%), Cefotaxime Sodium (0.002%), Ciprofloxacin (0.005%), ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%). 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.

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.

Liquichek Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Liquichek Tumor Marker Control is prepared from human source material with added constituents of human and animal origin, chemicals, stabilizers and preservatives. The control is provided in liquid form for convenience.

The D-10™ Hemoglobin A1c Program is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/ mol and NGSP %) in human whole blood using ion- exchange high-performance liquid chromatography (HPLC) on the D-10TM Hemoglobin Testing System. Hemoglobin Alc measurements are used as an aid in diagnosis of diabetes, as an aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. The D-10™ Hemoglobin A1c Program is intended for professional in vitro diagnostic use only.

The D-10™ Hemoglobin Testing System utilizes the principles of ion-exchange highperformance liquid chromatography (HPLC). A dual-piston, low pulsation HPLC pump and a proportioning value deliver the buffer solution to an analytical cartridge and detector. Whole blood samples undergo an automatic two step dilution process and then introduced into the analytical flow path. Pre-diluted samples are aspirated directly and introduced into the analytical flow path. Between sample injections, the sample probe is rinsed with Wash/Diluent Solution to minimize sample carryover. A programmed buffer gradient of increasing ionic strength delivers the sample to the analytical cartridge where the hemoglobin species are separated based upon their ionic interactions with the cartridge material and the buffer gradient. The separated hemoglobin species then pass through the photometer flow cell where changes in the absorbance are measured at 415 nm and recorded as a digital chromatogram. The software performs a reduction of raw data collected from each analysis that may indicate use of a calibration factor. A samples report and chromatogram are generated for each sample. The D-10™ Hemoglobin A1c Program is designed to be used on the D-10™ Hemoglobin Testing System with or without a D-10 Rack Loader.

Amplichek I is intended for use as an external assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the quantitative detection of Human Immunodeficiency Virus Type 1 (HIV-1), Hepatiis B Virus (HBV) and Hepatitis C Virus (HCV) for molecular diagnostic platforms listed in the package insert. This product is not intended to replace manufacturer controls provided with the device. This product is not intended for use with blood donor screening assays in U.S. or Canada.

Amplichek I is a set of quality controls consisting of four levels filled in individual vials with 1.2 mL of material. Each level is packaged separately in configuration of 10 tubes per box and four tubes per box in a MiniPak (trial size). This product is prepared from normal human plasma based material non-reactive to HIV-1 Ribonucleic Acid (RNA), HBV Deoxyribonucleic Acid (DNA) and HCV Ribonucleic Acid (RNA) with added proteins from human sources, antimicrobial agents as preservatives, and stabilizers. The positive levels are prepared using purified preparations of HIV, HBV and HCV isolated from human plasma or grown in cell cultures and are reactive for HIV-1 RNA, HBV DNA and HCV RNA. Amplichek I contains human plasma and purified retroviral and viral hepatitis materials derived from human plasma and/or cultured human cell line sources. Each human unit used in the preparation of this product is tested using licensed reagents and must be found to be non-reactive to HBsAg, antibodies to HIV-1 and HIV-2 and antibodies to HCV. Retroviral and viral hepatitis materials derived from human plasma and/or cultured human cell line sources are treated to inactivate infectious agents. However, no known test method can assure that products derived from human sources will not transmit infection. The labeling recommends that this product and all human specimens be handled in accordance with Biosafety Level 2 practices as described in the United States Department of Health and Human Services Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH), Biosafety in Microbiological and Biomedical Laboratories, or other equivalent guidelines. The package insert will provide lot specific mean and ranges for each analyte on various platforms. The assigned values listed in the proposed package insert were generated in the same manner as used for unknown specimens using FDA approved commercial test kits. The negative control reports qualitative results. The means for the positive controls were calculated from the total laboratory data generated for each analyte on the specific platform and the 3SD range was then assigned. The Amplichek I labeling recommends that each laboratory establish its own acceptable range for each analyte. Procedures for implementing a quality assurance program and monitoring test performance on a routine basis must be established by each individual laboratory. Amplichek I product should not be used as a standard. It is recommended that each laboratory establish its own means and acceptable ranges and use those provided only as quides.

Amplichek II is intended for use as an external assayed quality control material to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of Methicillin Resistant Staphylococcus aureus, Methicillin Sensitive Staphylococcus aureus, Clostridium difficile and Vancomycin-resistant Enterococci performed on Cepheid GeneXpert Systems. This product is not intended to replace manufacturer controls provided with the device. This product is only for use with assays and instruments listed in the Representative Results Chart in this labeling.

Amplichek II (Assayed Microbiology Control) is manufactured at three levels, Levels 1, 2 and 3, for each analyte indicated in the package insert. Individual analyte values are listed in the package insert and are specific for the instrument system or method utilized. Each control is prepared in liquid form in a buffer solution with preservatives including 5chloro-2-methyl-2H-isothiazol-3-one at a concentration of 0.1%, stabilizers and added preparations of purified intact microorganisms grown in microbial culture. Source materials are chemically treated and processed to inactivate infectious agents.