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ETEST® is a manual, quantitative technique for the determination of antimicrobial susceptibility of non‑fastidious Gram‑negative and Gram‑positive aerobic bacteria and fastidious bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in μg/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation. Testing with ETEST® Aztreonam/Avibactam (AZA) (0.016/4-256/4 μg/mL) is indicated for Enterobacterales, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC). The ETEST® Aztreonam/Avibactam (AZA) (0.016/4-256/4 μg/mL) demonstrated acceptable performance with the following microorganisms: • **Enterobacterales:** - Escherichia coli - Klebsiella pneumoniae - Klebsiella aerogenes - Citrobacter freundii complex - Citrobacter koseri - Enterobacter cloacae complex - Proteus mirabilis - Proteus vulgaris - Morganella morganii - Providencia stuartii - Serratia marcescens

ETEST® is a thin, inert and non-porous plastic strip carrying the MIC reading scale in μg/mL on one side and a predefined antibiotic gradient on the other side. When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of μg/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip. ETEST® Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) contains a range of Aztreonam from (0.016-256 µg/mL), overlaid with a fixed concentration of 4 µg/mL of Avibactam.

ETEST® is a manual, quantitative technique for the determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in µg/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation. Sulbactam/Durlobactam has been shown to be active against the Gram-negative aerobic microorganisms listed below according to the FDA label for this antimicrobial agent. ETEST® SUD can be used to determine the MIC of Sulbactam/Durlobactam against the following microorganisms: • Acinetobacter baumannii-calcoaceticus complex

ETEST® is a thin, inert and non-porous plastic strip carrying the MIC reading scale in us/mL on one side and a predefined antibiotic gradient on the other side. When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip. ETEST® Sulbactam/Durlobactam contains a range of Sulbactam from 0.004 to 64 µg/mL, overlaid with a fixed concentration of 4 µg/mL of Durlobactam.

VIDAS® NEPHROCHECK® is an automated test for use on the VIDAS® 3 instrument for the immunoenzymatic quantitative determination of TIMP-2 (Tissue Inhibitor of Metalloproteinase-2) and IGFBP-7 (Insulin-like Growth Factor-Binding Protein 7) proteins in human urine using the ELFA technique (Enzyme Linked Fluorescent Assay) for calculation of the AKIRISKTM Score. The VIDAS® NEPHROCHECK® assay is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. The VIDAS® NEPHROCHECK® test is intended to be used in patients 21 years of age or older.

Each VIDAS® NEPHROCHECK® kit contains: x60 NEPH Reagent Strips, x60 NEPH Solid Phase Receptacles (SPR), 1 NEPH control and 1 NEPH calibrator. The VIDAS® NEPHROCHECK® principle combines an enzyme immunoassay competition method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR®) serves as the solid phase as well as the pipetting device for the assay. The interior of the NEPH SPR is coated with mouse monoclonal lgG anti-IGFBP-7 andanti-TIMP-2. The Reagent Strips consist of 10 wells covered with a labeled foil seal. Well 1 is designated for the sample. Six of the wells contain conjugate, wash buffers and substrate. Last well contains the fluorescence substrate. All of the assay steps are performed automatically by the instrument. Two detection steps, one for each protein, are performed successively in Well 10. · The first step is a classical detection step with measurement of the substrate background and incubation of the substrate in the bottom of the SPR®, to generate the first fluorescent signal, which is specific for the IGFBP-7 protein. · Before the second detection step, the antibodies and proteins in the bottom of the SPR® are removed using the cleaning solution contained in Well 5. The previously used substrate in Well 10 is removed and replaced by fresh substrate contained in Well 9. A new substrate background is then measured, and the substrate is incubated in the top of the SPR® to generate the second fluorescent signal, which is specific for the TIMP-2 protein. For each protein, the intensity of the fluorescence is proportional to its concentration in the sample. At the end of the test, the protein concentrations are calculated by the instrument in relation to the two calibration curves, one corresponding to each protein, and encoded in the MLE data. The instrument calculates the AKIRISK™ Score, which is defined as the product of the concentrations of the two proteins, expressed in ng/mL, divided by 1000: AKIRISK™ Score = ([TIMP-2] x [IGFBP-7]) / 1000 The result of the VIDAS® NEPHROCHECK® assay is reported as the AKIRISK™ Score.

VITEK® 2 AST-Gram Positive Linezolid is designed for antimicrobial susceptibility testing of Gram positive microorganisms and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 AST-Gram Positive Linezolid is a quantitative test. Linezolid has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Enterococcus faecium (vancomycin-resistant isolates only) Staphylococcus aureus (including methicillin-resistant isolates) Streptococcus agalactiae In vitro data are available, but clinical significance is unknown: Enterococcus faecalis (including vancomycin-resistant isolates) Enterococcus faecium (vancomycin-susceptible isolates) Staphylococcus epidermidis (including methicillin-resistant isolates) Staphylococcus haemolyticus The VITEK® 2 Gram-positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.

The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh (1) and Gerlach (2). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique (3). Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card. VITEK® 2 AST-GP Linezolid has the following concentrations in the card: 0.5, 1, and 2 ug/mL (equivalent standard method concentration by efficacy in us/mL).

ETEST® is a manual, quantitative technique for the determination of antimicrobial susceptibility of non-fastidious Gram-negative and Gram-positive aerobic bacteria. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC, in ug/mL) of different antimicrobial agents against microorganisms tested on agar media after overnight incubation. Plazomicin has been shown to be active against most isolates of the bacteria listed below according to the FDA label for this antimicrobial agent. ETEST® PLZ can be used to determine the MIC of Plazomicin aqainst the following microorganisms: Active both in vitro and in clinical infections: - Escherichia coli - Klebsiella pneumoniae - Proteus mirabilis - Enterobacter cloacae In vitro data are available for the following microorganisms, but clinical significance is unknown: - Citrobacter freundii - Citrobacter koseri - Klebsiella (Enterobacter) aerogenes - Klebsiella oxytoca - Morganella morganii - Proteus vulgaris - Providencia stuartii - Serratia marcescens

ETEST® is a thin, inert and non-porous plastic strip carrying the MIC reading scale in µg/mL on one side and a predefined antibiotic gradient on the other side. When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip. ETEST® Plazomicin contains a range of plazomicin from 0.016 to 256 ug/mL.