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The VITEK® COMPACT PRO is intended for the automated quantitative and/or qualitative antimicrobial susceptibility testing of isolated colonies for most clinically significant aerobic Gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp., and yeast. The VITEK® COMPACT PRO is also intended for the automated identification of most clinically significant anaerobic organisms and Corynebacterium species, fermenting and nonfermenting Gram-negative bacilli, Gram-positive organisms, fastidious organisms, and yeasts and yeast-like organisms.

The VITEK® COMPACT PRO instrument is an automated instrument designed for use in low-to medium-range applications in both Clinical and Industry laboratories. The instrument performs sample well filling, incubation, and optical readings. The VITEK® COMPACT PRO instrument is a two-step automated instrument for: - Hydrating reagents with sample inoculum - Pre-processing cards, incubating cards, and continuous reading for growth The VITEK® 2 Systems Software receives the instrument optical readings and performs analysis. The instrument then ejects the completed reagent card into the waste area for disposal. The system includes a VITEK® COMPACT PRO instrument with an internal computer, monitor, keyboard, mouse, handheld barcode scanner, and USB hub. The software provided with the internal computer includes analysis and limited data management programs. A bidirectional computer interface (BCI) may transfer results automatically to the user's laboratory information system (LIS). A Quality Control System is available to track the quality control results of the test cards. The Advanced Expert System™ (Clinical Use) is available to provide online, systematic validation of results and interpretation of resistant phenotypes found during susceptibility testing.

The VIDAS® TBI (GFAP, UCH-L1) test is composed of two automated assays - VIDAS® TBI (GFAP) and VIDAS® TBI (UCH-L1) - to be used on the VIDAS® 3 instrument for the quantitative measurement of Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase (UCH-L1) in human serum using the ELFA (Enzyme Linked Fluorescent Assay) technique. The results of both assays are requred to obtain an overall qualitative test interpretation. The overall qualitative VIDAS® TBI (GFAP, UCH-L1) test result is used, in conjunction with clinical information, to aid in the evaluation of patients (18 years of age or older), presenting within 12 hours of suspected mild traumatic brain injury (Glasgow Coma Scale score 13-15), to assist in determining the need for a Computed Tomography (CT) scan of the head. A negative interpretation of VIDAS® TBI (GFAP, UCH-L1) test is associated with the absence of acute intracranial lesions visualized on a head CT scan.

The VIDAS® TBI (GFAP, UCH-L1) test is composed of two automated assays – VIDAS® TBI (GFAP) and VIDAS® TBI (UCH-L1) – to be used on the VIDAS® 3 instrument. Similar to other VIDAS assays, VIDAS TBI (GFAP) and VIDAS TBI (UCH-L1) test kits (specific to each biomarker) contain the solid phase receptacles (SPRs®), the reagent strips, Product Calibrator S1 and Product Control C1. These test kits will also contain the master lot entry (MLE) data i.e., a barcode printed on the outer label of the packaging, as well as the reference number of the package insert to download from the bioMérieux website. Whether it be for the GFAP or UCH-L1 quantification, the test combines a three-step enzyme immunoassay sandwich method with a final fluorescent detection step, also known as enzyme-linked fluorescent assay (ELFA). The Solid Phase Receptacle (SPR) serves as the solid phase as well as the pipetting device. The inner surface of the SPR is coated with antibodies aqainst the substance of interest i.e., anti-GFAP or anti-UCH-L1 antibodies. The reagent strip consists of 10 wells covered with a labeled foil seal. Well 1 is designated for the sample. Eight of the wells contain sample diluent, wash buffer, conjugate, and tracer. The last well contains the fluorescent substrate. All of the assay steps are performed automatically by the instrument. The intensity of the fluorescence is proportional to the concentration of the analyte the sample. At the end of the assay, the biomarker concentration is automatically calculated by the instrument in relation to the calibration curve and stored in the Master Lot Entry (MLE) data. VIDAS TBI (GFAP) and VIDAS TBI (UCH-L1) results are reported separately: the VIDAS 3 reports the calculated concentration and the qualitative interpretation for each. The final result i.e., the patient's status in relation to suspected mild traumatic brain injury, must be interpreted by the user according to the decision tree presented in the package insert.