Study of the Performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA

Study Overview
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Brief Summary
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In vitro identification of S. aureus,methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)from positive blood culture using MicroPhage's bacteriophage-based diagnostic platform.

Detailed Description
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This is a multi-center clinical study to investigate the effectiveness of the performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA. The KeyPath test is performed directly on positive blood culture specimens from bioMerieux BacT/ALERT blood culture bottles. The MicroPhage test will be compared to standards and market available tests with similar indications (comparators). It is estimated that the study will last 3-4 months depending on the accural rate at the institutions.

Official Title
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Prospective Study Into the Performance of the KeyPathtm MRSA/MSSA Blood Culture Test - BTA

Conditions
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Bacteremia

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Blood culture samples determined to be Gram-positive from subjects aged 18+, inclusive, with any of the following bottle types: bioMerieux BacT/ALERT® Standard Aerobic and Anaerobic bioMerieux BacT/ALERT® FAN Aerobic and FAN Anaerobic Completion of the KeyPathTM BTA Test on the sample. Completion of the reference method for S. aureus identification (tube coagulase and Remel Staphaurex ) and completion of the reference method for methicillin resistance determination (30 µg cefoxitin disc diffusion) for S. aureus positive samples. Exclusion Criteria: Samples from blood culture positives over 24 hours from alarm Samples deemed contaminated. Violations and/or deviations from the KeyPathTM BTA Test protocol and/or other included test protocols under study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard of Care<br>Comparison of S. aureus to the reference methods for S. aureus (tube coagulase and Staphaurex.) Comparison to the reference method (30 ug cefoxitin disc diffusion). | |
| KeyPath Test Group<br>All specimens collected that meet the inclusion criteria will be tested using the KeyPath BTA Test. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prospective study into the performance of the KeyPath MRSA/MSSA Blood Culture Test -BTA | A. Determination of the performance of the KeyPathTM MRSA/MSSA Blood Culture Test - BTA for identification of S. aureus and determination of MRSA and MSSA direct from clinical blood culture positives by: i. KeyPathTM MRSA/MSSA Blood Culture Test - BTA for identification of S. aureus to the reference methods for S. aureus (tube coagulase and Staphaurex). ii. KeyPathTM MRSA/MSSA Blood Culture Test - BTA for determination of MRSA and MSSA among S. aureus positives by comparison to the reference method (30 µg cefoxitin disc diffusion). | 3-4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Staphylococcus aureus, methicillin resistant, MRSA, MSSA, Blood Culture, Diagnostic