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VITEK®2 Gram Negative Tigecycline is intended for antimicrobial susceptibility testing of Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Citrobacter koseri, Enterobacter aerogenes, and Serratia marcescens. VITEK 2 Gram Negative Tigecycline is a qualitative test. It is intended for use with the VITEK 2 Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents.

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 and VITEK® 2 Compact Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli and Staphylococcus spp., Enterococcus spp., Streptococcus agalactiae, and S. pneumoniae.

The VITEK 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdifution methodology. The bacterial isolate to be tested is diluted to a standardized concentration in 0.45% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK 2 automatically fills, seals and places the card into the incubator/reader. The VITEK 2 Compact has a manual filling and sealing operation. The VITEK 2 systems monitor the growth of each well in the card over a defined period of time (up to 18 hours). 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.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

The document states "An external evaluation was conducted with fresh and stock clinical isolates and stock challenge strains." However, it does not explicitly state the specific sample size (number of isolates) used for the test set. It also does not explicitly state the country of origin of the data. The mention of "fresh clinical isolates" suggests some prospective collection, while "stock clinical isolates and stock challenge strains" indicate retrospective or pre-existing samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not provide information on the number of experts used or their qualifications.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The study compares the device performance to a reference method (NCCLS/CLSI agar dilution), not to human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the study describes the standalone performance of the VITEK 2 Gram Negative Tigecycline system, as it compares its output directly to the reference method without human interpretation as part of the evaluated performance metric.

7. The Type of Ground Truth Used:

The ground truth used was the NCCLS reference agar dilution method (later referred to as CLSI agar dilution reference method). This is a well-established laboratory method for determining antimicrobial susceptibility.

8. The Sample Size for the Training Set:

The sample size for the training set is not explicitly mentioned in the provided text. The document focuses on the external evaluation data used for performance validation.

9. How the Ground Truth for the Training Set Was Established:

The document does not provide information on how the ground truth for the training set was established. It only describes the ground truth used for the external evaluation (NCCLS/CLSI agar dilution method).

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